[Federal Register: August 24, 2001 (Volume 66, Number 165)] [Proposed Rules] [Page 44671-44720] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24au01-38]
Addenda
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 413, et al.
Medicare Program; Changes to the Hospital Outpatient Prospective
Payment System and Calendar Year 2002 Payment Rates; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 413, 419, and 489
[CMS-1159-P]
RIN 0938-AK54
Medicare Program; Changes to the Hospital Outpatient Prospective
Payment System and Calendar Year 2002 Payment Rates
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the Medicare hospital
outpatient prospective payment system to implement applicable statutory
requirements, including relevant provisions of the Medicare, Medicaid,
and SCHIP Benefits Improvement and Protection Act of 2000 and changes
arising from our continuing experience with this system. In addition,
it would describe proposed changes to the amounts and factors used to
determine the payment rates for Medicare hospital outpatient services
paid under the prospective payment system. These changes would be
applicable to services furnished on or after January 1, 2002.
DATES: We will consider comments if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on October 3, 2001.
ADDRESSES: In commenting, please refer to file code CMS-1159-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. Mail written comments (one original and
three copies) to the following address only: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-1159-P, P.O. Box 8017, Baltimore, MD 21244-8017.
To ensure that mailed comments are received in time for us to
consider them, please allow for possible delays in delivery.
If you prefer, you may deliver (by hand or courier) your written
comments (one original and three copies) to one of the following
addresses:
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received too late for us to
consider them.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
When ordering copies of the Federal Register containing this
document, see the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: George Morey (410) 786-4653, for
provider-based issues; and Nancy Edwards (410) 786-0378, for all other
issues.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments
Comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244-
1850 on Monday through Friday of each week from 8:30 a.m. to 4 p.m. To
schedule an appointment to view public comments, please call (410) 786-
7195 or (410) 786-4668.
Availability of Copies and Electronic Access
Copies: To order copies of the Federal Register containing this
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libraries throughout the country that receive the Federal Register.
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. The Website address is: http://
www.access.gpo.gov/nara/index.html. To assist readers in referencing
sections contained in this document, we are providing the following
table of contents.
Outline of Contents
I. Background
A. Authority
B. Summary of Rulemaking
C. Summary of Relevant Provisions of the Benefits Improvement
and Protection Act of 2000 (BIPA 2000)
1. Accelerated Reduction of Beneficiary Copayment
2. Revision of Payment Update
3. Process and Standards for Determining Eligibility of Devices
for Transitional Pass-Through Payments
4. Application of Transitional Corridor Payments to Certain
Hospitals That Did Not Submit A 1996 Cost Report
5. Treatment of Children's Hospitals
6. Transitional Pass-Through Payment for Temperature Monitored
Cryoablation
7. Contrast Enhanced Diagnostic Procedures
8. Other Changes
II. Proposed Changes to the Ambulatory Payment Classification (APC)
Groups and Relative Weights
A. Recommendations of the Advisory Panel on APC Groups
1. Establishment of the Advisory Panel
2. Specific Recommendations of the Advisory Panel and Our
Responses
B. Additional APC Changes Resulting from BIPA Provisions
1. Coverage of Glaucoma Screening
2. APCs for Contrast Enhanced Diagnostic Procedures
C. Other Changes Affecting the APCs
1. Changes in Revenue Code Packaging
2. Special Revenue Code Packaging for Specific Types of
Procedures
3. Limit on Variation of Costs of Services Classified Within a
Group
4. Observation Services
5. List of Procedures That Will Be Paid Only As Inpatient
Procedures
6. Additional New Technology APC Groups
D. Recalibration of APC Weights for CY 2002
III. Wage Index Changes
IV. Copayment Changes
A. BIPA 2000 Coinsurance Limit
B. Impact of BIPA 2000 Payment Rate Increase on Coinsurance
C. Coinsurance and Copayment Changes Resulting from Change in an
APC Group
V. Outlier Policy Changes
VI. Other Policy Decisions and Proposed Changes
A. Change in Services Covered Within the Scope of the OPPS
B. Categories of Hospitals Subject To and Excluded from the OPPS
C. Conforming Changes: Additional Payments on a Reasonable Cost
Basis
D. Hospital Coding for Evaluation and Management Services
E. Annual Drug Pricing Update
F. Definition of Single-Use Devices
G. Criteria for New Technology APCs
1. Background
2. Proposed Modifications to the Criteria and Process for
Assigning Services to New Technology APCs a. Services Paid Under New
Technology APCs b. Criteria for Assignment to New Technology APC c.
Revision of Application for New Technology Status d. Length of Time
in a New Technology APC
VII. Transitional Pass-Through Payment Issues
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A. Background
B. Discussion of Pro-Rata Reduction
1. Data and Methodology
2. Drugs and Biologicals
3. Radiopharmaceutical Drugs and Biological Products
4. Medical Devices
5. Projecting to 2002
C. Reducing Transitional Pass-Through Payments to Offset Costs
Packaged into APC Groups
1. Background
2. Proposed Reduction for 2002
VIII. Conversion Factor Update for CY 2002
IX. Summary of and Responses to MedPAC Recommendations
X. Provider-Based Issues
A. Background and April 7, 2000 Regulations
B. Provider-Based Issues/Frequently Asked Questions
C. Benefits Improvement and Protection Act of 2000
1. Two-Year ``Grandfathering'
2. Geographic Location Criteria
3.Criteria for Temporary Treatment as Provider--Based
D. Proposed Changes to Provider-Based Regulations
1. Clarification of Requirements for Adequate Cost Data and Cost
Finding
2. Scope and Definitions
3. BIPA Provisions on Grandfathering and Temporary Treatment as
Provider-Based
4. Reporting
5. Geographic Location Criteria
6. Notice to Beneficiaries of Coinsurance Liability
7. Clarification of Protocols for Off-Campus Departments
8. Other Changes
XI. Summary of Proposed Changes
A. Changes Required by BIPA
B. Additional Changes
C. Technical Corrections
XII. Collection of Information Requirements
XIII. Response to Public Comments
XIV. Regulatory Impact Analysis
Regulations Text
Addenda
Addendum A--List of Ambulatory Payment Classifications (APCs) with
Status Indicators, Relative Weights, Payment Rates, and Copayment
Amounts
Addendum B--Payment Status by HCPCS Code, and Related Information
Addendum C--Hospital Outpatient Payment for Procedures by APC:
Displayed on Website Only
Addendum D--Payment Status Indicators for the Hospital Outpatient
Prospective Payment System
Addendum E--CPT Codes Which Would Be Paid Only As Inpatient
Procedures
Addendum G--Service Mix Indices by Hospital: Displayed on Website
only
Addendum H--Wage Index for Urban Areas
Addendum I--Wage Index for Rural Areas
Addendum J--Wage Index for Hospitals That Are Reclassified
Alphabetical List of Acronyms Appearing in the Proposed Rule
APC Ambulatory payment classification
APG Ambulatory patient group
ASC Ambulatory surgical center
AWP Average wholesale price
BBA 1997 Balanced Budget Act of 1997
BIPA 2000 Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000
BBRA 1999 Balanced Budget Refinement Act of 1999
CAH Critical access hospital
CAT Computerized axial tomography
CCI Correct Coding Initiative
CCR Cost center specific cost-to-charge ratio
CMHC Community mental health center
CMS Centers for Medicare & Medicaid Services (Formerly known as the
Health Care Financing Administration)
CORF Comprehensive outpatient rehabilitation facility
CPI Consumer Price Index
CPT (Physician's) Current Procedural Terminology, Fourth Edition,
2001, copyrighted by the American Medical Association
DME Durable medical equipment
DMEPOS DME, prosthetics (which include prosthetic devices and
implants) orthotics, and supplies
DRG Diagnosis-related group
EMTALA Emergency Medical Treatment and Active Labor Act
FDA Food and Drug Administration
FQHC Federally qualified health center
HCPCS Healthcare Common Procedure Coding System
HHA Home health agency
ICD-9-CM International Classification of Diseases, Ninth Edition,
Clinical Modification
IME Indirect medical education
JCAHO Joint Commission on Accreditation of Healthcare Organizations
MRI Magnetic resonance imaging
MSA Metropolitan statistical area
NECMA New England County Metropolitan Area
OPPS Hospital outpatient prospective payment system
PPS Prospective payment system
RFA Regulatory Flexibility Act
RHC Rural health clinic
RRC Rural referral center
SCH Sole community hospital
SNF Skilled nursing facility
I. Background
A. Authority
When the Medicare statute was originally enacted, Medicare payment
for hospital outpatient services was based on hospital-specific costs.
In an effort to ensure that Medicare and its beneficiaries pay
appropriately for services and to encourage more efficient delivery of
care, the Congress mandated replacement of the cost-based payment
methodology with a prospective payment system (PPS). The Balanced
Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997,
added section 1833(t) to the Social Security Act (the Act) authorizing
implementation of a PPS for hospital outpatient services. The Balanced
Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), enacted on
November 29, 1999, made major changes that affected the hospital
outpatient PPS (OPPS). The Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554),
enacted on December 21, 2000, made further changes in the OPPS. The
BIPA provisions that affect the OPPS are summarized below, in section
I.C. The OPPS was first implemented for services furnished on or after
August 1, 2000.
B. Summary of Rulemaking
On September 8, 1998, we published a proposed rule (63 FR
47552) to establish in regulations a PPS for hospital outpatient
services, to eliminate the formula-driven overpayment for certain
hospital outpatient services, and to extend reductions in payment for
costs of hospital outpatient services. On June 30, 1999, we published a
correction notice (64 FR 35258) to correct a number of technical and
typographic errors in the September 1998 proposed rule including the
proposed amounts and factors used to determine the payment rates.
On April 7, 2000, we published a final rule with comment
period (65 FR 18438) that addressed the provisions of the PPS for
hospital outpatient services scheduled to be effective for services
furnished on or after July 1, 2000. Under this system, Medicare payment
for hospital outpatient services included in the PPS is made at a
predetermined, specific rate. These outpatient services are classified
according to a list of ambulatory payment classifications (APCs). The
April 7 final rule with comment period also established requirements
for provider departments and provider-based entities and prohibited
Medicare payment for non-physician services furnished to a hospital
outpatient by a provider or supplier other than a hospital unless the
services are furnished under arrangement. In addition, this rule
extended reductions in payment for costs of hospital outpatient
services as required by the BBA of 1997 and
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amended by the BBRA of 1999. Medicare regulations governing the
hospital OPPS are set forth at 42 CFR 419.
On June 30, 2000, we published a notice (65 FR 40535)
announcing a delay in implementation of the OPPS from July 1, 2000 to
August 1, 2000.
On August 3, 2000, we published an interim final rule with
comment period (65 FR 47670) that modified criteria that we use to
determine which medical devices are eligible for transitional pass-
through payments. The August 3, 2000 rule also corrected and clarified
certain provider-based provisions included in the April 7, 2000 rule.
On November 13, 2000, we published an interim final rule
with comment period (65 FR 67798). This rule provided for the annual
update to the amounts and factors for OPPS payment rates effective for
services furnished on or after January 1, 2001. We also responded to
public comments on those portions of the April 7, 2000 final rule that
implemented related provisions of the BBRA and public comments on the
August 3, 2000 rule.
C. Summary of Relevant Provisions of the BIPA
The BIPA, which was enacted on December 21, 2000, made the
following changes to the Act relating to OPPS.
1. Accelerated Reduction of Beneficiary Copayment
Section 111 amended section 1833(t)(8)(C) of the Act to limit the
national copayment rate for OPPS services to 57 percent of the OPPS
payment rate for services furnished in 2001 on or after April 1, 2001;
55 percent for services in 2002 and 2003; 50 percent for services
furnished in 2004; 45 percent for services furnished in 2005; and 40
percent for services furnished in 2006 and thereafter.
Section 111 also specifies that nothing in BIPA 2000 or the Act,
shall be viewed as preventing a hospital from waiving the amount of any
beneficiary coinsurance for outpatient hospital services that may have
been increased as a result of implementation of the OPPS.
2. Revision of Payment Update
Section 401 amended section 1833(t)(3)(C) of the Act to provide in
2001 an update equal to the full rate of increase in the market basket
index. The 2002 update factor remains as it was under the law before
the enactment of BIPA, that is, the market basket index percentage
increase minus 1 percentage point.
3. Process and Standards for Determining Eligibility of Devices for
Transitional Pass-Through Payments
Section 402 amended section 1833(t)(6) of the Act to require that
the determination of eligibility for transitional pass-through payments
be based on categories of devices (previously, eligibility was
determined on a device-specific basis). The establishment of an initial
set of categories was required effective for services furnished on or
after April 1, 2001. This provision was implemented on March 22, 2001
in Program Memorandum (PM) No. A-01-41, which set forth a list of 96
initial categories.
Section 402 of the BIPA also provides that the Secretary must
establish criteria to use in creating additional device categories.
These criteria will be set forth in an interim final rule with comment
period that will be published in the Federal Register at a later date.
Related to this issue is the issue of pro rata reductions of
transitional pass through payments for new technology. A discussion of
this can be found later in this document in Section VII. B.
4. Application of Transitional Corridor Payments to Certain Hospitals
That Did Not Submit a 1996 Cost Report
Section 403 amended section 1833(t)(7)(F)(ii)(I) of the Act to
allow transitional corridor payments to hospitals subject to the OPPS
that did not have a 1996 cost report by authorizing the use of the
first available cost reporting period ending after 1996 and before
2001.
5. Treatment of Children's Hospitals
Section 405 amended section 1833(t) of the Act to give children's
hospitals the same permanent hold harmless protection as cancer
hospitals under the OPPS.
6. Transitional Pass-Through Payment for Temperature Monitored
Cryoablation
Section 406 amended section 1833(t)(6)(A)(ii) of the Act to include
devices of temperature monitored cryoablation as eligible for
transitional pass-through payments. This provision will be included in
the interim final rule concerning changes in eligibility of devices for
transitional pass-through payments mentioned above.
7. Contrast Enhanced Diagnostic Procedures
Section 430 amended section 1833(t)(2) of the Act to require that
procedures that use contrast agents be classified in groups that are
separate from those to which procedures not using contrast agents are
assigned. We implemented this provision in PM No. A-01-73, issued on
June 1, 2001. In addition, section 430 amended section 1861(t)(1) of
the Act to expand the definition of drugs to include contrast agents
effective for contrast agents furnished on or after July 1, 2001.
8. Other Changes
In addition to the provisions directly related to OPPS, BIPA
included the following provisions that will require revision in the
services assigned to APCs in the OPPS:
Section 102 amended section 1861(s)(2) of the Act to allow
coverage of glaucoma screening for certain high risk individuals
effective for services furnished on or after January 1, 2002.
Section 104(d)(2) directed the Secretary to determine if
HCPCS codes are appropriate to describe mammography that uses new
technology. The Secretary has created these codes for 2002.
Throughout this proposed rule, we discuss these various provisions
and the changes we are proposing to make in the OPPS for them.
II. Proposed Changes to the APC Groups and Relative Weights
Under the OPPS, we pay for hospital outpatient services on a rate
per service basis that varies according to the APC group to which the
service is assigned. Each APC weight represents the median hospital
cost of the services included in that APC relative to the median
hospital cost of the services included in APC 0601, Mid-Level Clinic
Visits. As described in the April 7, 2000 final rule (65 FR 18484), the
APC weights are scaled to APC 0601 because a mid-level clinic visit is
one of the most frequently performed services in the outpatient
setting.
Section 1833(t)(9)(A) of the Act requires the Secretary to review
the components of the OPPS not less often than annually and to revise
the groups and related payment adjustment factors to take into account
changes in medical practice, changes in technology, and the addition of
the new services, new cost data, and other relevant information.
Section 1833(t)(9)(A) of the Act requires the Secretary, beginning in
2001, to consult with an outside panel of experts when annually
reviewing and updating the APC groups and the relative weights.
Finally, section 1833(t)(2) of the Act provides that, subject to
certain exceptions, the items and services within an APC group cannot
be considered comparable with respect to
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the use of resources if the highest median or mean cost item or service
in the group is more than 2 times greater than the lowest median or
mean cost item or service within the same group (referred to as the ``2
times rule''). We use the median cost of the item or service in
implementing this provision. The statute authorizes the Secretary to
make exceptions to the 2 times rule ``in unusual cases, such as low
volume items and services.''
The APC groups that we are proposing in this rule as the basis for
payment in 2002 under the OPPS have been analyzed within this statutory
framework.
A. Recommendations of the Advisory Panel on APC Groups
1. Establishment of the Advisory Panel
Section 1833(t)(9)(A) of the Act, which requires that we consult
with an outside panel of experts when annually reviewing and updating
the APC groups and the relative weights, specifies that the panel will
act in an advisory capacity. The expert panel, which is to be composed
of representatives of providers, is to review and advise us about the
clinical integrity of the APC groups and their weights. The panel is
not restricted to using our data and may use data collected or
developed by organizations outside the Department in conducting its
review.
On November 21, 2000, the Secretary signed the charter establishing
an ``Advisory Panel on APC Groups'' (the Panel). The Panel is technical
in nature and is governed by the provisions of the Federal Advisory
Committee Act (FACA) as amended (Public Law 92-463). To establish the
Panel, we solicited members in a notice published in the Federal
Register on December 5, 2000 (65 FR 75943). We received applications
from more than 115 individuals nominating either themselves or a
colleague. After carefully reviewing the applications, CMS chose 15
highly qualified individuals to serve on the panel. The Panel was
convened for the first time on February 27, February 28, and March 1,
2001. We published a notice in the Federal Register on February 12,
2001 (66 FR 9857) to announce the location and time of the Panel
meeting, a list of agenda items, and that the meeting was open to the
public. We also provided additional information through a press release
and our website.
2. Specific Recommendations of the Advisory Panel and Our Responses
In this section of the proposed rule, we summarize the issues
considered by the Panel, the Panel's APC recommendations, and our
subsequent action with regard to the Panel's recommendations. The data
used by the Panel in making its recommendation are the 1996 claims that
were used to set the APC weights and payment rates for CY 2000 and
2001.
As discussed below, the Panel sometimes declined to recommend a
change in an APC even though the APC violated the 2 times rule. In
section II.C.3 of this preamble, we discuss our proposals regarding the
2 times rule based on the data we are using to recalibrate the 2002 APC
relative weights (that is, claims for services furnished on or after
July 1, 1999 and before July 1, 2000). That section also details the
criteria we use in deciding to make an exception to the 2 times rule.
We asked the Panel to review many of the exceptions we implemented in
2000 and 2001. The exceptions are referred to as ``violations of the 2
times'' rule in the following discussion.
APC 0016: Level V Debridement & Destruction
APC 0017: Level VI Debridement & Destruction
We asked the Panel to review the current placement of CPT code
56501, Destruction of lesion(s), vulva; simple, any method, in APC 0016
because the APC violates the 2 times rule. Because the procedure is a
simple destruction of skin and superficial subcutaneous tissues, we
would not expect it to have a median cost of $500. Thus, we believe
that the higher costs associated with this code were the result of
incorrect coding. To ensure that procedures in APC 0016 comply with the
2 times rule, we asked the Panel to consider one of the following
clinical options:
Move CPT code 56501 to APC 0017.
Retain CPT code 56501 in APC 0016 but split APC 0016 into
three APCs to distinguish simple destruction lesions from extensive
destruction lesions.
The Panel rejected the option to split APC 0016 into three
different APCs. The members stated that there was no validity in taking
that approach because simple versus extensive destruction of lesions
had greater significance in relation to physician work than in
measuring facility resource use. They believed that many of the
procedures assigned to APC 0016 are performed in a procedure room
rather than in the operating room. The Panel considered factors such as
the use of anesthesia and the method used to destroy the lesions as
indicators of differences in facility resource consumption between
simple and extensive destruction of lesions. The Panel agreed that the
simple destruction of lesions should be assigned to the same APC as the
extensive destruction of lesions if a laser is used to remove simple
lesions. In this case, the Panel stated that the similarity in resource
use is based on the method or technique used to perform the procedure.
The Panel also noted that CPT code 11042, Debridement; skin,
subcutaneous tissue, and muscle, is the most frequently performed
procedure in APC 0016, accounting for approximately 85 percent of this
APC's total volume. The Panel noted that this code had probably been
billed incorrectly because of widespread misunderstanding about its
definition.
The Panel also reviewed procedures assigned to APCs 0014 (Level III
Debridement & Destruction) and 0015 (Level IV Debridement &
Destruction) and compared similarities and differences among those
procedures and the ones assigned to APCs 0016 and 0017. During this
comparative review, the Panel compared CPT code 56501 to the following
two CPT codes: 46917, Destruction of lesion(s), anus, simple; laser
surgery, which is assigned to APC 0014, and 54055, Destruction of
lesion(s), penis, simple; electrodesiccation, which is assigned to APC
0016. In reviewing these three procedures, the Panel questioned whether
the resources involved supported their current APC assignments. After
considerable discussion, the Panel recommended the following:
Move CPT code 56501 from APC 0016 to APC 0017.
Move CPT code 46917 from APC 0014 to APC 0017.
The Panel recommended these changes to achieve clinical coherence
and resource similarity among the procedures assigned to these APCs.
Because CPT code 46917 is performed using laser equipment and requires
anesthesia, the Panel believed it appropriate to move this procedure to
APC 0017. Although the Panel considered the reassignment of CPT code
54055 to APC 0017, it did not recommend this change. The Panel's
recommended changes would group in APC 0017 simple destruction of
lesion procedures that use laser or surgical techniques with extensive
destruction of lesion procedures.
We propose to accept the Panel's recommendation regarding CPT code
56501 and to revise the APC accordingly. However, as shown below in
Table 3, we are proposing to make
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additional changes to these APCs because of the 2 times rule.
APC 0024: Level I Skin Repair
APC 0025: Level II Skin Repair
APC 0026: Level III Skin Repair
APC 0027: Level IV Skin Repair
The composition of procedures in APCs 0025 and 0027 results in
these APCs violating the 2 times rule. Therefore, we requested the
Panel's advice in exploring other clinical options for reconfiguring
the four skin repair APCs to achieve clinical and resource homogeneity
among the procedures assigned to APCs 0025 and 0027 while retaining
clinical and resource homogeneity for APCs 0024 and 0026. We asked the
Panel to consider the following clinical options to achieve this
result:
Rearrange the procedures assigned to APCs 0024 through
0027 based on the size or the length of the skin incision.
Rearrange the procedures assigned to APCs 0024 through
0027 based on the complexity of the repair, such as distinguishing
repairs that involve layers of skin, flaps, or grafts from those that
do not.
The Panel reviewed the various options presented, which were
modeled based on the 1996 claims data used in constructing the current
APC groups and payment rates. Using these data, the Panel discussed
size and complexity of the various repairs, considered the clinical
differences in performing the repairs on different anatomical sites,
and the clinical differences involved in making skin repairs using
flaps and grafts versus layers of skin. As a result of its review, the
Panel stated that they found no compelling clinical advantages in the
options presented. The Panel also agreed that more current data would
be needed to make appropriate recommendations about the actual merits
and benefits of the various options. For these reasons, the Panel
recommended the following:
Make no changes to APCs 0024 and 0027.
Reevaluate these APCs with new data when the Panel meets
in 2002.
The Panel, in preparation for the 2002 meeting, will
discuss with and gather clinical and utilization information from their
respective hospitals regarding these procedures.
We propose to accept the Panel's recommendations. However, as shown
in Table 3, we are proposing to make changes to these APCs based on the
use of new data and application of the 2 times rule.
APC 0058: Level I Strapping and Casting Application
APC 0059: Level II Strapping and Casting Application
APC 0058 (which consists of the simpler casting, splinting, and
strapping procedures) violates the 2 times rule. The median costs for
high volume procedures in APC 0058 vary widely, ranging from $27 to
$83. The median costs associated with presumably more resource-
intensive procedures in APC 0059 are fairly uniform, ranging from $69
to $119. To limit the cost variation in APC 0058, we asked the Panel to
consider the following options:
Move the following four codes from APC 0058 to APC 0059:
CPT code 29515, Application of short splint (calf to foot); CPT code
29520, Strapping; hip; CPT code 29530, Strapping; knee; and CPT code
29590, Denis-Brown splint strapping.
Create a new APC to include a third level of strapping and
casting application procedures by regrouping all procedures assigned to
both APCs 0058 and 0059 based on the following clinical distinctions:
Removal/revision, strapping/splinting, and casting.
Package certain CPT codes assigned to APC 0058 with
relevant procedures.
The Panel discussion revealed that codes grouped in APC 0058 are
not always appropriately billed by hospitals. The Panel pointed out
that code descriptors such as ``strapping of the hip'' are not commonly
understood by hospital staff. The Panel noted that before
implementation of OPPS, hospitals billed the items described by these
codes as supplies (without a CPT code) when they were billed as
anything other than an emergency room visit. They also stated that the
use of these codes has been confused with the use of some codes
associated with durable medical equipment. For these reasons, the Panel
believed that the procedure costs reflected in our data are skewed. As
a result, the Panel recommended that we do the following:
Make no changes to APC 0058.
Provide appropriate education and guidance to hospitals
regarding appropriate use and billing of codes in APC 0058.
Resubmit APC 0058 to the Panel for reevaluation when later
data are available.
We propose to accept the Panel's recommendations except that we
propose to move CPT code 29515 to APC 0059 due to the 2 times rule and
the newer data we are using for this proposed rule.
APC 0079: Ventilation Initiation and Management
The codes in APC 0079 represent respiratory treatment and support
provided in the outpatient setting. The cost variation among the
assigned procedures in this APC raises concern about hospital coding
practices. The median costs for these procedures range from $40 to
$315. We asked the Panel to clarify whether these procedures are
performed on outpatients or if they are performed on patients who come
to the emergency room and are later admitted to the hospital as
inpatients.
The Panel acknowledged that there are major problems associated
with appropriately assigning codes to these procedures which results in
incorrect billing. The Panel concluded that additional information is
necessary to better understand the issues raised. The Panel also
advised that CPT code 94660, Continuous positive airway pressure
ventilation (CPAP), initiation and management, is a sleep apnea
procedure used in the treatment of obesity and is clinically different
from all other procedures in APC 0079. For these reasons, the Panel
recommended the following:
Remove CPT code 94660 from APC 0079 and create a new APC
for this one procedure.
We propose to accept the Panel's recommendation by creating a new
APC 0065, CPAP Initiation.
APC 0094: Resuscitation and Cardioversion
We requested the Panel's assistance in determining whether it is
clinically appropriate to remove the cardioversion procedures from APC
0094 because the rest of the procedures assigned to APC 0094 are
emergency procedures rather than elective. We proposed that the Panel
consider the creation of a new APC for the cardioversion procedures or
reassignment of the procedures to another APC that would be more
appropriate in terms of clinical coherence and resource similarity.
Splitting APC 0094 into two distinct groups, one for resuscitation
procedures and the other for internal and external electrical
cardioversion procedures, would not result in a significant difference
in the APC payment rate for either of the new APCs.
The Panel considered whether it was clinically appropriate to
combine internal and external cardioversion procedures (CPT codes 92960
and 92961, respectively) in the same APC. The Panel also questioned the
conditions under which internal cardioversion procedures would be
performed on an outpatient basis.
[[Page 44677]]
The Panel recommended that the only action we should take is to
move CPT code 92961, Cardioversion, elective, electrical conversion of
arrhythmia; internal (separate procedure), from APC 0094 to APC 0087,
Cardiac Electrophysiology Recording/Mapping.
We propose to accept the APC Panel recommendation.
APC 0102: Electronic Analysis of Pacemakers/Other Devices
The neurologic procedures included in APC 0102 (CPT codes 95970
through 95975), are significantly more complex than the routine cardiac
pacemaker programming codes also assigned to this APC. Because we
believe these codes are clinically different, we asked the Panel to
consider the following:
Create a new APC for the neurologic codes.
Move the neurologic codes to APC 0215, Level I Nerve and
Muscle Tests.
One presenter appearing before the Panel stated that APC 0102
involves clinical functions related to four different categories of
devices; that is, pacemakers, defibrillators, infusion pumps, and
neurostimulators. The presenter, who represented a device
manufacturers' association, contended that these four categories of
devices differ clinically. The presenter also stated that patients
receiving these devices are clinically different and are even treated
by different hospital departments. The presenter recommended the
following:
Split APC 0102 into two APCs: One APC for electronic
analysis of pacemakers and other cardiac devices and a separate APC for
electronic analysis of infusion pumps and neurostimulators.
The APC created for electronic analysis of infusion pumps
and neurostimulators would include the following CPT codes:
------------------------------------------------------------------------
Code Descriptor
------------------------------------------------------------------------
62367............................ Analyze spine infusion pump.
62368............................ Analyze spine infusion pump.
95970............................ Analyze neurostim, no prog.
95971............................ Analyze neurostim, simple.
95972............................ Analyze neurostim, complex.
95973............................ Analyze neurostim, complex.
95974............................ Cranial neurostim, complex.
95975............................ Cranial neurostim, complex.
------------------------------------------------------------------------
The APC created for electronic analysis of pacemakers and
other cardiac devices would include the following CPT codes:
------------------------------------------------------------------------
Code Descriptor
------------------------------------------------------------------------
93727............................ Analyze ilr system.
93731............................ Analyze pacemaker system.
93732............................ Analyze pacemaker system.
93733............................ Telephone analy, pacemaker.
93734............................ Analyze pacemaker system.
93735............................ Analyze pacemaker system.
93736............................ Telephone analy, pacemaker.
93737............................ Analyze cardio/defibrillator.
93738............................ Analyze cardio/defibrillator.
93741............................ Analyze ht pace device sngl.
93742............................ Analyze ht pace device single.
93743............................ Analyze ht pace device dual.
93744............................ Analyze ht pace device dual.
------------------------------------------------------------------------
The presenter stated that reorganizing APC 0102 as recommended
would establish groups that are more clinically and resource similar
than the current grouping. The presenter believes that APC 0102 as
currently configured violates the 2 times rule. The median costs for
the 21 procedures currently included in APC 0102 vary from $19 to $145.
Other presenters clarified clinical aspects of the procedures,
identified which practitioners perform them, the time it takes to
perform them, and how they are to be billed. Yet another presenter
speaking on behalf of a specialty society noted that the society had
previously commented on this APC and requested that we remove CPT codes
93737 and 93738 from APC 0102.
The Panel noted that because most of the codes are new, having been
established since 1996 (the base year of data available to the Panel),
these newer procedures could not have been included in the data file
used to create the current APC payment rates. In the absence of
frequency and median cost data for many of these procedures, the Panel
was concerned about reorganizing the codes in this APC. Nonetheless,
the Panel recommended the following reorganization of APC 0102 to
better reflect clinical coherence:
APC 0102 be split into four new APCs: One APC for analysis
and programming of infusion pumps and CSF shunts; a second for analysis
and programming of neurostimulators; a third for analysis and
programming of pacemakers and internal loop recorders; and a fourth for
analysis and programming of cardioverter-defibrillators.
We propose to accept the Panel's recommendations and propose to
create four new APCs as follows:
APC 0689: Electronic Analysis of Cardioverter-Defibrillator
APC 0690: Electronic Analysis of Pacemakers and Other Cardiac Devices
APC 0691: Electronic Analysis of Programmable Shunts/Pumps
APC 0692: Electronic Analysis of Neurostimulator Pulse Generators.
APC 0110: Transfusion
APC 0111: Blood Product Exchange
APC 0112: Extracorporeal Photopheresis
The procedures included in APC 0110 are those related only to the
services associated with performing the blood transfusion and
monitoring the patient during the transfusion; the costs associated
with the blood products themselves are not included in APC 0110. We
advised the Panel that we were not certain that cost data for blood
transfusions excluded the costs of the blood products because the APC
0110 median cost of $289 seemed excessive. We expressed concern about
hospital coding and billing practices for blood products, blood
processing, storage, and transportation charges as represented in the
1996 data. We asked the Panel to advise us on how to clarify hospital
billing and coding practices for blood transfusions; we also asked if
the Panel members believe that the median costs for transfusion
procedures include the costs for blood products and, if so, how the
procedures should be adjusted to eliminate these costs.
A presenter representing a device manufacturers' association noted
that these issues were examined extensively by several specialty
societies that sent considerable data to us on the actual cost of the
transfusion procedures before publication of the April 7, 2000 final
rule (65 FR 18434). The presenter stated that the median costs for
transfusion procedures that we used in calculating the final payment
rate for APC 0110 was somewhat lower than the costs submitted by the
specialty societies. The presenter believes that our experience under
the APC system is too limited for us to make a judgment concerning the
validity of the median costs. The presenter also believes that the
payment rate for APC 0110 should have been adjusted to include costs
for blood safety tests, such as the hepatitis and HIV look-back tests
mandated by the FDA over the past several years, because these costs
were not included in the 1996 data used to construct the APC rates. The
presenter stated that these tests are expensive and that they increase
the hospitals' costs to provide the blood. However, it was unclear
whether these tests are separately billable under the lab fee schedule.
In addition, the presenter explained that blood centers do not
charge hospitals for blood because it is voluntarily donated, not
manufactured. The presenter stated that blood centers charge hospitals
what it costs them to provide the blood and that hospitals bill
[[Page 44678]]
acquisition and processing charges rather than charges for the blood
itself. Based on the information provided, the presenter urged the
Panel not to revise APC 0110 until more data become available.
For APC 0111, another representative of a specialty society
recommended that CPT code 36521, Therapeutic apheresis; with
extracorporeal affinity column absorption and plasma reinfusion, be
moved from APC 0111 to APC 0112. The presenter stated that CPT code
36521 is more similar clinically and in resource use to 36522,
Photopheresis, extracorporeal which is in APC 0112. The presenter
stated that a major difference between the procedure represented by CPT
codes 36521 and 36520, Therapeutic Apheresis; plasma and/or cell
exchange, which is also assigned to APC 0111, and the other procedures
codes assigned to APC 0111, is that hospitals can bill separately for
blood products such as the plasma or albumin used in performing plasma
exchange procedures. The presenter described CPT code 36521 as a
``self-contained'' procedure not requiring the use of albumin or
plasma, because the patient's own blood is processed through a machine
and returned to the patient. The presenter stated that the materials
and equipment used to perform this procedure make it much more costly
than the other procedures assigned to APC 0111. The presenter, citing
cost data from two medical centers where CPT code 36521 is frequently
performed, stated that the total cost of the procedure, including the
cost of the adsorption column, is approximately $2000. At this time,
the commenter noted, only one of the adsorption columns (Prosorba) used
for this procedure is eligible for transitional pass-through payments,
which means that payments for this procedure, which are based upon the
APC payment alone, are too low when one of the other columns is used
and no additional pass-through payment is made. It was stated that the
cost of many of the adsorption columns is over $1000 per column. The
presenter concluded that moving CPT code 36521 from APC 0111 to APC
0112 would comply with the statutory requirements for clinical
coherence and resource similarity among procedures in the same APC.
The Panel discussed various adsorption devices used in performing
CPT code 36521, their eligibility for transitional pass-through
payments, as well as the clinical and resource use difference between
CPT codes 36520 and 36551. After considerable discussion, the Panel
recommended the following:
Take no action on APC 0110.
Move CPT code 36521 from APC 0111 to APC 0112 to achieve
clinical coherence and resource similarity with photopheresis
procedures included in APC 0112. However, the Panel cautioned that the
payment for APC 0112 captured the cost of the entire procedure
including the cost of the adsorption column. For this reason, any
additional payment for the adsorption column through the transitional
pass-through payment mechanism would be a duplicate payment. Therefore,
the panel asked that CMS address this problem when considering their
recommendation.
We propose to accept the Panel's recommendations. We note that
effective April 1, 2001, the Prosorba column is no longer eligible for
a transitional pass-through payment (see PMA-01-40 issued on March 27,
2001).
APC 0116: Chemotherapy Administration by Other Technique Except
Infusion
APC 0117: Chemotherapy Administration by Infusion Only
APC 0118: Chemotherapy Administration by Both Infusion and Other
Technique
We had received several comments requesting that oral delivery of
chemotherapy and delivery of chemotherapy by infusion pumps and
reservoirs be recognized for payment under the OPPS. We asked the Panel
to examine this issue.
With regard to oral administration of chemotherapy, the Panel heard
several presenters discuss the need for extensive beneficiary education
prior to administration of oral anticancer agents. The Panel agreed
that the beneficiaries actually self-administer the drug and that
beneficiary education was appropriately billed as a clinic visit. The
Panel stated that this would be true whether the education involved
cancer chemotherapy, diabetes management, or congestive heart failure
management. Therefore, the Panel recommended that no new codes be
created to specifically recognize oral administration of chemotherapy.
With regard to recognizing chemotherapy administration through
infusion pumps and ports, the Panel heard several presentations that
this is becoming a common method of administering not only cancer
chemotherapy but also for administering other types of pharmaceuticals.
It was pointed out that because CPT codes 96520, Refilling and
maintenance of portable pump, and 96530, Refilling and maintenance of
implantable pump or reservoir, were excluded from the OPPS it was
impossible for hospitals to be paid when performing these services.
After lengthy discussion, the Panel recommended that refilling and
maintenance of pumps and reservoirs be assigned to an APC.
The Panel also discussed the current HCPCS Q codes for chemotherapy
administration and concluded that these codes should continue to be
recognized in the OPPS. In addition, the Panel discussed whether a new
Q code should be developed for extended chemotherapy infusions.
In summary, the Panel recommended the following:
Hospitals be allowed to bill for patient education under
the appropriate clinic codes.
CPT codes 96520 and 96530 be assigned to a new APC.
The current HCPCS Level II Q codes for chemotherapy
administration should continue to be used.
There is no need to develop a new HCPCS code for
``extended chemotherapy infusions.''
CMS should consider developing a new HCPCS code for
flushing of ports and reservoirs.
We propose to accept all the Panel recommendations except for the
recommendation regarding flushing of ports and reservoirs. Flushing is
performed in conjunction with either a chemotherapy administration
service or an outpatient clinic visit. In the first case, flushing is
part of the chemotherapy administration and its costs are adequately
captured in the costs of the chemotherapy administration code. In the
second case, we believe that the costs of flushing are adequately
captured in the costs of the clinic visit and need not be paid
separately. We are proposing to create a new APC 0125, Refilling of
Infusion Pump.
APC 0123: Bone Marrow Harvesting and Bone Marrow/Stem Cell
Transplant
In APC 0123, the 1996 median cost for CPT code 38230, Bone marrow
harvesting for transplantation, was only $15. We believe that this cost
is lower than the actual cost of the procedure. Further, we do not have
sufficient data to determine how often bone marrow and stem cell
transplant procedures are performed on an outpatient basis. For these
reasons, we requested the Panel's advice in clarifying the resources
used in performing the procedures assigned to APC 0123, and the extent
to which these procedures are performed on an outpatient basis.
The Panel noted that these transplant and stem cell harvesting
procedures are
[[Page 44679]]
being increasingly performed on an outpatient basis. One presenter
representing a specialty society stated that 95 percent of these
procedures are performed in the hospital outpatient setting. The
presenter shared cost data from the bone marrow transplant unit of an
academic medical center that showed the cost to harvest bone marrow to
be about $1,800. The presenter observed that this cost is significantly
higher than the APC payment rate of about $205 for APC 0123. Another
presenter representing a group of hospitals stated that the supply
costs alone for bone marrow harvesting are more than the current APC
payment for the procedure. The presenter suggested that miscoding may
have contributed to the low $15 median cost reflected in our database.
After discussion, the Panel recommended the following:
Make no changes in the procedures assigned to APC 0123 in
the absence of sufficient data to support such modifications.
The two presenters on this APC issue submit cost data for
the Panel to use in reevaluating this issue at its 2002 meeting.
We note that our analysis of the more recent claims data we are
using to reclassify and recalibrate the APCs in this proposed rule
reveals a significant increase in costs for this APC resulting in a
proposed payment rate that is double the current rate. However, very
few procedures (fewer than 20) were billed on an outpatient basis. We
will have the Panel review this APC again at their next meeting.
APC 0142: Small Intestine Endoscopy
APC 0143: Lower GI Endoscopy
APC 0145: Therapeutic Anoscopy
APC 0147: Level II Sigmoidoscopy
APC 0148: Level I Anal/Rectal Procedures
APC 0149: Level II Anal/Rectal Procedures
APC 0150: Level III Anal/Rectal Procedures
We presented these seven APCs to the Panel because of the
inconsistencies in the median costs for some procedures included in
APCs 0142, 0143, 0145, and 0147. We advised the Panel that our cost
data do not show a progression of median costs proportional to
increases in clinical complexity as we would expect. For example, the
data indicate that a therapeutic anoscopy assigned to APC 0145 costs
more than twice as much as a flexible or rigid sigmoidoscopy assigned
to APC 0147. We stated our concern that cost disparity could provide
incentives to use inappropriate procedures. Because of these concerns,
we asked the Panel's advice in determining whether one of the following
actions should be taken:
Divide the codes in APC 0142 into separate APCs
representing ileoscopy and small intestine procedures.
Combine diagnostic anoscopy and Level I sigmoidoscopy.
Merge APCs 0143, 0145, and 0147 into one APC.
We also asked the Panel whether the costs associated with codes in
APC 0145 appeared to be valid.
During the Panel discussion, it was noted that the data distributed
to the Panel for these APCs indicated that most of the procedures are
billed as single procedures only 50 percent of the time. This raised
questions as to whether the data include procedures such as flexible
sigmoidoscopies that were miscoded as rigid sigmoidoscopies,
colonoscopies, and anoscopies. In examining the data, the Panel
considered what impact this miscoding would have on the cost data, and
discussed the clinical approaches used to perform some of the
procedures, what type of practitioners perform them, and other
procedures and supplies that would be billed with them. As a result of
this discussion, the Panel concluded that the data anomalies were
probably attributable to miscoding because hospitals have not received
sufficient guidance and information on appropriately coding procedures
included in these APCs. The Panel also agreed that it would need more
current data before it could consider reconfiguring these APCs.
Therefore, the Panel recommended that we do the following:
Make no changes to APCs 0142, 0143, 0145, and 0147.
Provide information and guidance to better assist
hospitals in understanding how to bill appropriately for services
included in APCs 0142, 0143, 0145, and 0147.
Resubmit these APCs to the Panel for review when newer
data are available.
We propose to accept the Panel's recommendations.
APC 0151: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
We advised the Panel that we have received comments that indicate
that it is inappropriate to assign both diagnostic and therapeutic ERCP
procedures to the same APC. The commenters allege that virtually every
hospital performs diagnostic ERCPs but only teaching hospitals perform
therapeutic ERCPs. Based on our current data, if we created two APCs
for ERCP procedures, the APC payment rate for therapeutic ERCPs would
be lower than that for diagnostic ERCPs (approximately $526 and $535,
respectively). Therefore, we requested the Panel's advice to help us
determine whether to create separate APCs for diagnostic and
therapeutic ERCP procedures.
A presenter speaking on behalf of a specialty society made the
following points:
ERCP is the most complex endoscopy procedure to perform
and is usually performed by gastroenterologists.
ERCP is usually performed at large hospitals.
The most complex ERCP procedures are usually performed in
teaching hospitals.
Current payments for ERCP are lower than the costs to
perform the procedure (based on cost and frequency data gathered from
several teaching hospitals).
Single claims should not be used to calculate an APC
payment rate for ERCP services because a single ERCP procedure usually
consists of several components, each with its own CPT code (e.g.,
sphincterotomy and stent placement). Therefore, an ERCP billed as a
single CPT code would represent aberrant billing and would not
accurately reflect the costs of an ERCP.
The OPPS data distributed to the Panel verified that the vast
majority of the ERCP procedures are performed as multiple procedures.
The Panel agreed that the use of single claims data could possibly skew
the APC payment rate for ERCP services.
The Panel recommended that we do the following:
Do not reconfigure the ERCP procedures in APC 0151.
Resubmit this issue to the Panel for review when more
recent data are available.
Explore the feasibility of using multiple claims rather
than single claims to calculate appropriate APC payment rates for ERCP
procedures.
We propose to accept the Panel's recommendations. We are currently
reviewing the potential for using multiple claims data for determining
payment rates for ERCP procedures. As a first step in the process, in
this proposed rule, we have determined a payment rate for ERCP
procedures based on both single claims for ERCP procedures and, because
ERCP procedures are typically done under radiologic guidance, on claims
that included both an ERCP procedure and a radiologic supervision or
guidance
[[Page 44680]]
procedure in this APC. Using these additional claims has resulted in
significantly increasing the number of claims used to determine the
payment rate for this APC and in a much higher proposed payment rate
(about $825).
APC 0160: Level I Cystourethroscopy and other Genitourinary
Procedures
APC 0161: Level II Cystourethroscopy and other Genitourinary
Procedures
APC 0162: Level III Cystourethroscopy and other Genitourinary
Procedures
APC 0163: Level IV Cystourethroscopy and other Genitourinary
Procedures
APC 0169: Lithotripsy
We advised the Panel that we had received a number of comments that
advocated moving CPT code 52337, Cystoscopy, with ureteroscopy and/or
pyeloscopy; with lithotripsy (ureteral catheterization is included),
from APC 0162 to APC 0163. (We note that CPT code 52337 was deleted for
2001 and replaced with an identical CPT code, 52353. We will use the
new code in the following discussion.) Because of these comments, we
sought the Panel's advice in examining the clinical and resource
distinctions between CPT code 52353 and other procedures assigned to
APC 0162. Other information shared with the Panel noted that most of
the procedures included in APC 0162 are complicated cystourethroscopies
while those assigned to APC 0163 are largely prostate procedures.
One presenter representing a device manufacturer discussed the
merits of reassigning CPT code 52353 to either APC 0163 or 0169 (APC
0169 contains a single CPT code, 50590, Lithotripsy, extracorporeal
shock wave (ESWL)). The presenter was concerned that our decision to
assign the cystourethroscopic procedure to APC 0162 rather to APC 0163
was not explained in our April 7, 2000 final rule.
Furthermore, the presenter noted that this decision resulted in a
40 percent decline in payment for the procedure which will make it
difficult for hospitals to provide this service because the capital
equipment, probes, and fibers required to perform the procedure are
expensive. Moreover, the probes and fibers are ineligible for
transitional pass-through payments because they are not single-use
items. At the Panel's request, the presenter discussed the clinical
differences between CPT codes 52353 and 50590. The presenter stated
that code 50590 is a noninvasive procedure that involves breaking up
kidney stones using shock waves produced outside the patient while code
52353 is an invasive procedure that requires the urologist to insert
different instruments through a cystoscope and a uretheroscope to
access stones in the upper urinary tract (the ureter and kidney).
The presenter also compared the cost of performing CPT code 52353
with that for CPT code 52352, which involves the mechanical removal of
stones. The presenter asked the Panel to consider the following two
options to resolve this issue:
Reassign CPT code 52353 to APC 0169, Lithotripsy. The
presenter believes that this would be the most appropriate assignment
clinically and from a cost perspective because both involve lithotripsy
and require expensive capital equipment, fibers, and probes. Also,
other payers using a similar procedure grouping system, ambulatory
procedure groups (APGs), have grouped these procedures together.
Restore CPT code 52353 to its original APC assignment, APC
0163.
In addition, the presenter expressed concern that the large number
of procedures assigned to APC 0162 makes it difficult to achieve
clinical homogeneity within the APC. The presenter asked that we work
with appropriate groups to reconfigure APC 0162 because, as
constituted, it appears to violate the 2 times rule.
The Panel had a lengthy discussion regarding whether to move CPT
code 52353 to APC 0163 or to APC 0169. The Panel considered the
resources used for procedures in APCs 0163 and 0169 and noted that the
lithotriptor used for code 50590 may be purchased or leased and that
lease rates for lithotriptors have frequently been inflated.
Furthermore, it noted that much of the equipment and resource use
required for code 52353 is similar to the resource use of other
procedures in APC 0163. In spite of these considerations, the Panel
voted eight to seven to recommend moving CPT code 52353 from APC 0162
to APC 0169 because both codes 52353 and 50590 are lithotripsy
procedures.
We reviewed the panel discussion very carefully and noted the close
vote. After careful consideration, we propose to disagree with the
Panel's recommendation and move code 52353 to APC 0163. The 1999-2000
cost data, which contains over 400 single claims for code 52353 and
over 6,000 single claims for code 50590, show that the median cost for
code 52353 is much more similar to the median cost of other procedures
in APC 0163 than it is to the median cost of APC 0169. Although both
codes involve lithotripsy, the type of equipment used in the two
procedures is very different. Clinically, the surgical approach used
for code 52353 and the resources used (e.g., anesthesia and operating
room costs) are much more similar to other procedures in APC 0163 than
to those for code 50590. Additionally, the median cost for code 50590,
which is $700 higher than that of code 52353, is dependent on the
widely variable arrangements hospitals make for use of the
extracorporeal lithotriptor. Therefore, we believe that placing code
52353 in APC 0163 maintains its clinical coherence and similar use of
resources.
APC 0191: Level I Female Reproductive Procedures
APC 0192: Level II Female Reproductive Procedures
APC 0193: Level III Female Reproductive Procedures
APC 0194: Level IV Female Reproductive Procedures
APC 0195: Level V Female Reproductive Procedures
This group of APCs was presented to the Panel because APC 0195
violates the 2 times rule. To facilitate the Panel's review of this
issue, we distributed cost data on all the female reproductive
procedures assigned to these five APCs. These data showed that the
median costs for procedures assigned to APC 0195 ranged from a low of
$365 to a high of $1,817. The CPT code 57288, Sling operation for
stress incontinence (e.g., fascia or synthetic), which is assigned to
APC 0195, has the highest median cost of the procedures in this group.
We discussed with the Panel two clinical options for rearranging the
procedures assigned to APC 0195 to comply with the 2 times rule. The
first option would split APC 0195 into two separate APCs by separating
vaginal procedures from abdominal procedures. The second option would
split APC 0195 into three distinct APCs by retaining the separate APCs
for abdominal and vaginal procedures and further distinguishing vaginal
procedures based on whether they are simple or complex.
The Panel discussed the rapid increase in the rate at which CPT
code 57288 is performed on an outpatient basis. The Panel stated that
this procedure is becoming more routine and replacing many of the
older, more complex urinary dysfunctional procedures. Questions were
raised about the frequency with which this procedure is performed alone
as opposed to being performed as one of several procedures. The Panel
was advised that the sling material and the relevant anchors used in
performing
[[Page 44681]]
CPT code 57288 are eligible for transitional pass-through payments.
One presenter, speaking on behalf of a device manufacturer,
supported our proposal to divide APC 0195 into different clinical
groupings. The presenter's testimony was limited to a discussion of CPT
code 57288. The presenter concurred with the Panel's assessment of the
current utilization trends for CPT code 57288, emphasized the high
costs associated with performing this procedure, and highlighted the
wide variation in techniques and devices used to perform it. Because of
these factors, the presenter believes that the procedure is underpaid
and that the 1996 cost data may not fully reflect the actual costs
associated with performing CPT code 57288.
The Panel also closely reviewed the other four APCs for female
reproductive procedures to ensure each was clinically homogeneous. As a
result of this review, the Panel recommended a number of changes for
these APCs. These recommendations and those for APC 0195 are as
follows:
Move CPT codes 56350, Hysteroscopy, diagnostic, and 58555,
Hysteroscopy, diagnostic/separate procedure, from APC 0191 to APC 0194
(In 2001, CPT code 56350 was replaced with CPT code 58555.)
Divide APC 0195 into two APCs to distinguish vaginal
procedures from abdominal procedures.
Retain the following vaginal procedures in APC 0195:
------------------------------------------------------------------------
CPT code Descriptor
------------------------------------------------------------------------
57555.................... Excision of cervical stump, vaginal approach:
with anterior and/or posterior repair.
58800.................... Drainage of ovarian cyst(s), unilateral or
bilateral, (separate procedure); vaginal
approach.
58820.................... Drainage of ovarian abscess; vaginal
approach, open.
57310.................... Closure of urethrovaginal fistula.
57320.................... Closure of vesicovaginal fistula; vaginal
approach.
57530.................... Trachelectomy (cervicectomy), amputation of
cervix (separate procedure).
57291.................... Construction of artificial vagina; without
graft.
57220.................... Plastic operation on urethral sphincter,
vaginal approach (e.g., Kelly urethral
plication).
57550.................... Excision of cervical stump, vaginal approach.
57556.................... Excision of cervical stump, vaginal approach;
with repair of enterocele.
57289.................... Pereyra procedure, including anterior
colporrhaphy.
57300.................... Closure of rectovaginal fistula; vaginal or
transanal approach.
57284.................... Paravaginal defect repair (including repair
of cystocele, stress urinary incontinence,
and/or incomplete vaginal prolapse).
57265.................... Combined anteroposterior colporrhaphy; with
enterocele repair.
57268.................... Repair of enterocele vaginal approach
(separate procedure).
56625.................... Vulvectomy simple; complete.
58145.................... Myomectomy excision of fibroid tumor of
uterus, single or multiple (separate
procedure); vaginal approach.
57260.................... Combined anteroposterior colporrhaphy.
57240.................... Anterior colporrhaphy, repair of cystocele
with or without repair of urethrocele.
57250.................... Posterior colporrhaphy, repair of rectocele
with or without perineorrhaphy.
56620.................... Vulvectomy simple; partial.
57522.................... Conization of cervix, with or without
fulguration, with or without dilation and
curettage, with or without repair; loop
electrode excision.
------------------------------------------------------------------------
Include the following abdominal procedures in a new APC
titled ``Level VI Female Reproductive Procedures.''
------------------------------------------------------------------------
CPT code Descriptor
------------------------------------------------------------------------
58920.................... Wedge resection or bisection of ovary,
unilateral or bilateral.
58900.................... Biopsy of ovary, unilateral or bilateral
(separate procedure).
58925.................... Ovarian cystectomy, unilateral or bilateral.
57288.................... Sling operation for stress incontinence
(e.g., fascia or synthetic).
57287.................... Removal or revision of sling for stress
incontinence (e.g., fascia or synthetic).
------------------------------------------------------------------------
Move CPT code 57107 from APC 0194 to APC 0195, Level V
Female Reproductive Procedures.
Move CPT code 57109, Vaginectomy with removal of
paravaginal tissue (radical vaginectomy) with bilateral total pelvic
lympadenectomy and para-oortic lymph node sampling (biopsy), from APC
0194 to the new APC, Level VI Female Reproductive Procedures.
We propose to accept all of these Panel recommendations. These APCs
would be reconfigured and renumbered as APCs 0188 to 0194. We are also
proposing to add new APCs for Level VII and Level VIII Female
Reproductive Procedures (APCs 0195 and 0202, respectively) based on the
1999-2000 claims data and the 2 times rule.
APC 0210: Spinal Tap
APC 0211: Level I Nervous System Injections
APC 0212: Level II Nervous System Injections
The Panel heard testimony from two presenters regarding the merits
of modifying these three APCs. The first presenter, speaking on behalf
of a manufacturer, discussed CPT code 64614, Chemodenervation of
muscles; extremities and/or trunk muscles (e.g., for dystonia, cerebral
palsy, multiple sclerosis). The presenter advised the Panel that
although this is a new code for 2001, the procedure is well established
and formerly coded using CPT code 64640, Destruction by neurolytic
agent; other peripheral nerve or branch. The new code was created to
distinguish chemodenervation of limb and trunk muscles from other
chemodenervation procedures. The presenter claimed that this code is
similar both clinically and in terms of resource use to the other
chemodenervation procedures assigned to APC 0211, so it should be
assigned to that APC instead of APC 0971, New Technology--Level II,
where it is currently assigned.
The second presenter, representing a specialty society, proposed
regrouping the procedures assigned to APCs 0210, 0211, and 0212 based
on similar levels of complexity and median costs. The presenter's
proposal also included reassignment to these APCs of interventional
pain procedures
[[Page 44682]]
currently assigned to APCs 040, Arthrocenteris and Ligament/Tendon
Injection, 0105, Revision/Removal of Pacemakers, AICD, or Vascular
Device, and 0971. The presenter contended that it was essential to
reconfigure these APCs because of disparity in resource use among
procedures currently assigned to the same APC. The presenter also
claimed that many of these procedures are being underpaid in their
current APC and, for that reason, a number of hospitals have chosen not
to perform them in the outpatient setting. The presenter proposed
establishing the following five levels of interventional pain
procedures by regrouping the procedures into new APCs as stated below:
Level I Nerve Injections (to include Trigger Point, Joint,
Other Injections, and Lower Complexity Nerve Blocks):
------------------------------------------------------------------------
Reassigned
CPT code from APC
------------------------------------------------------------------------
20550................................................... 040
20600................................................... 040
20605................................................... 040
20610................................................... 040
64612................................................... 0211
64613................................................... 0211
64614................................................... 0971
64400-64418............................................. 0211
64425................................................... 0211
64430................................................... 0211
64435................................................... 0211
64445................................................... 0211
64450................................................... 0211
64505................................................... 0211
64508................................................... 0211
------------------------------------------------------------------------
Level II Nerve Injections (to include Moderate Complexity
Nerve Blocks and Epidurals):
------------------------------------------------------------------------
Reassigned
CPT code from APC
------------------------------------------------------------------------
27096................................................... 0210
62270................................................... 0210
62272................................................... 0210
62273................................................... 0212
62310-62319............................................. 0212
------------------------------------------------------------------------
Level III Nerve Injections (to include Moderately High Complexity
Epidurals, Facet Blocks, and Disk Injections):
------------------------------------------------------------------------
CPT code Reassigned from APC
------------------------------------------------------------------------
62280-62282.............................. 0212
62290.................................... Currently Packaged.
62291.................................... Currently Packaged.
64420-64421.............................. 0211
64470.................................... 0211
64472.................................... 0211
64475-64476.............................. 0211
64479.................................... 0211
64480.................................... 0211
64483-64484.............................. 0211
64510.................................... 0211
64520.................................... 0211
64530.................................... 0211
64630.................................... 0211
64640.................................... 0211
------------------------------------------------------------------------
Level IV Nerve Injections (to include High Complexity
Lysis of Adhesions, Neurolytic Procedures, Removal of Implantable Pumps
and Stimulators):
------------------------------------------------------------------------
Reassigned
CPT code from APC
------------------------------------------------------------------------
62263................................................... 0212
64600................................................... 0211
64605................................................... 0211
64610................................................... 0211
64620................................................... 0211
64622-64623............................................. 0211
64626-64627............................................. 0211
64680................................................... 0211
62355................................................... 0105
62365................................................... 0105
------------------------------------------------------------------------
Level V Nerve Injections (to include Highest Complexity
Disk and Spinal Endoscopies): CPT code 62287, Aspiration or
decompression procedure, percutaneous, of nucleus pulposus of
invertebral disk, any method, single or multiple levels, lumbar (e.g.,
manual or automated percutaneous diskectomy, percutaneous laser
diskectomy), reassigned from APC 0220, Level I Nerve Procedures.
The Panel recommended reassignment of CPT code 64614 from APC 0971
to APC 0211.
Concerning the suggested regrouping of interventional pain
procedures, the Panel agreed that the recommended division of these
procedures by clinical complexity would reflect resource use and was a
reasonable approach to take. It was pointed out to the Panel that the
costs for CPT codes 62290, Injection procedure for diskography, each
level; lumbar, and 62291, Injection procedure for diskography, each
level; cervical or thoracic, were packaged into the procedures with
which they were billed. Therefore, the Panel concurred with the
regrouping of procedures to establish Levels I, II, III, and IV with
the following exceptions:
The Panel recommended that CPT codes 62290 and 62291 not
be included in Level III because they are packaged injections and
should not be unpackaged and paid separately.
The Panel opposed moving CPT codes 62355, Removal of
previously implanted intrathecal or epidural catheter, and 62365,
Removal of subcutaneous reservoir or pump, previously implanted for
intrathecal or epidural infusion, from APC 0105 to Level IV Nerve
Injections because they were neither clinically similar nor similar in
resource use to the other codes assigned to this proposed APC.
The Panel opposed the creation of Level V Nerve Tests as
it included only one code and recommended that CPT code 62287 remain in
APC 220.
We propose to accept the Panel's recommendations for these
services. We propose to create new APCs 0203, 0204, 0206, and 0207 to
accommodate these proposed changes.
APC 0215: Level I Nerve and Muscle Tests
APC 0216: Level II Nerve and Muscle Tests
APC 0217: Level III Nerve and Muscle Tests
We advised the Panel that we had received a comment contending that
assignment of CPT code 95863, Needle electromyography, three
extremities with or without related paraspinal areas, to APC 0216
created an inappropriate incentive to perform tests on three
extremities rather than two or four extremities. The payment of about
$144 for APC 0216 is greater than the payment of about $58 for the same
tests when performed on one, two, or four extremities. This is due to
the fact that CPT codes 95860, 95861, and 95864, Needle
electromyography, one, two, and four extremities with or without
related paraspinal areas, respectively, are assigned to APC 0215. We
distributed data to the Panel that showed a median cost of about $141
for CPT code 95863, which is more than 3 times that of the median cost
of $41 for CPT code 95864. We asked the Panel to consider the
reassignment of CPT code 95863 from APC 0216 to APC 0215 and advised
the Panel that, based on cost data available at the time of our
meeting, this change could potentially reduce the payment for APC 0216.
It was also noted that this change could result in a payment increase
for APC 0215.
The Panel reviewed the cost data for APCs 0215 and 0216 and noted
that the median costs for both CPT codes 95863 and 95864 appeared
aberrant. Based on the information presented, the Panel recommended
that we move CPT code 95863 from APC 0216 to APC 0215.
We propose to accept the Panel's recommendation with one exception.
We are proposing to revise these APCs based on the 1999-2000 cost data
and the 2 times rule, and CPT code 95863 would be assigned to a
reconfigured APC for Level II Nerve and Muscle Tests (APC 0218).
[[Page 44683]]
APC 0237: Level III Posterior Segment Eye Procedures
We advised the Panel that procedures assigned to APC 0237 are high
volume procedures and rank among the top outpatient procedures billed
under Medicare. We have received a number of comments disagreeing with
the assignment of CPT code 67027, Implantation of intravitreal drug
delivery system (e.g., ganciclovoir implant), which includes
concomitant removal of vitreous, to APC 0237. This procedure was added
to the CPT coding system after 1996 and, therefore, was not included in
the 1996 data. We advised the Panel that ganciclovoir, the drug
implanted during this procedure, is paid separately as a transitional
pass-through item. Because the drug is paid separately, it should not
be included in determining whether the resources associated with the
surgical procedure are similar to the resources required to perform the
other procedures assigned to APC 0237. We advised the Panel that, of
the procedures assigned to APC 0237, we believe that CPT code 67027 is
related to codes 65260, 65265, and 67005, all of which involve removal
of foreign bodies and vitreous from the eye. To ensure that CPT code
67027 is assigned to the appropriate APC, we asked the Panel to
consider creation of a new APC, Level IV Posterior Segment Eye
Procedures, for CPT codes 65260, 65265, 67005, and 67027. Based on the
APC rates effective January 1, 2001, the suggested change could lower
the APC rate for the four procedures by $400.
The Panel reviewed the data and did not believe it was sufficient
to support the creation of a new APC for these four procedures.
Therefore, the Panel recommended that APC 0237 remain intact and that
more recent claims data be analyzed to determine whether CPT code 67027
is similar to the other procedures assigned to APC 0237.
Based on the 1999-2000 claims data, we have determined that the
resources used for code 67027 are similar to other procedures in APC
0237. However, we will present APCs 0235, 0236, and 0237 to the Panel
at their next meeting to determine whether any further changes should
be made. We are proposing to make various other changes to these APCs
based on the new data and the 2 times rule.
APC 0251: Level I ENT Procedures
This APC violates the 2 times rule because it consists of a wide
variety of minor ENT procedures, many of which are low volume services
or codes for nonspecific procedures. In order to correct this problem,
we proposed to the Panel that this APC be split by surgical site (e.g.,
nasal and oral). After reviewing cost data, the Panel agreed that the
APC should be split but that current data were insufficient to
determine how that split should be made. Therefore, the Panel asked
that this APC, along with more recent cost data, be placed on the
agenda at the next meeting.
We agree that this APC should be reviewed by the Panel at its next
meeting. However, our review of the more recent cost data indicates
that significant violations of the 2 times rule still exist. In order
to correct this problem, but keep the APC as intact as possible, we
propose to move CPT codes 30300, Remove foreign body, intranasal;
office type procedure, 40804, Removal of embedded foreign body,
vestiblue of mouth; simple, and 42809, Removal of foreign body from
pharynx, to APC 0340, Minor Ancillary Procedures. This APC consists of
procedures such as removal of earwax that require similar resources.
APC 0264: Level II Miscellaneous Radiology Procedures
We asked the panel to review this APC because it violated the 2
times rule and consisted of a wide variety of unrelated procedures.
Specifically, we believe that the costs associated with CPT codes
74740, Hysterosalpingography, radiological supervision and
interpretation, and 76102, Radiologic examination, complex motion
(e.g., hypercycloidal) body section (e.g., mastoid polytomography),
other than with urography; bilateral, were aberrant and that we would
significantly underpay these procedures if we moved them into a lower
paying APC. We also asked the Panel to determine whether this APC and
APC 0263, Level I Miscellaneous Radiology Procedures, should be
reconfigured by body system. After considerable discussion, the Panel
agreed that the procedures in these APCs were not clinically
homogeneous; however, it recommended that we leave these APCs intact
because the data do not support any more coherent reorganization. The
Panel requested that this APC be placed on the agenda for the 2002
meeting.
We agree with the Panel with the following revisions. First, BIPA
requires us to assign procedures requiring contrast into different APCs
from procedures not requiring contrast. This required changes to a
number of radiologic APCs including APCs 0263 and 0264. In addition, in
this proposed rule, we would move CPT code 75940, Percutaneous
Placement of IVC filter, radiologic supervision and interpretation, to
a new APC 0187, Placement/Reposition Miscellaneous Catheters, because
its costs were significantly higher than the costs of the procedures
remaining in APC 0264.
APC 0269: Echocardiogram except Transesophageal
APC 0270: Transesophageal Echocardiogram
We asked the Panel to consider splitting these APCs based on
whether or not 2D imaging is employed. After review of the data, the
Panel recommended that we leave these APCs intact.
We propose to leave APC 0270 intact except for the addition of two
new codes for transesophageal echocardiography. We also propose to
split APC 0269 into two APCs, APC 0269, Level I Echocardiogram Except
Transesophageal and APC 0697, Level II Echocardiogram Except
Transesophageal. One APC (0697) would include comprehensive
echocardiograms and the other APC (0269) would include limited/follow-
up echocardiograms and doppler add-on procedures.
APC 0274: Myelography
We advised the Panel that APC 0274 is clinically homogeneous but
that it violates the 2 times rule. Procedures assigned to this APC
include radiological supervision and interpretation of diagnostic
studies of central nervous system structures (e.g., spinal cord and
spinal nerves) performed after injection of contrast material. We
shared data with the Panel that showed the median costs for the
procedures assigned to this APC ranged from a low of about $109 to a
high of about $295. We asked the Panel's recommendation for
reconfiguring APC 0274 to comply with the 2 times rule.
We informed the Panel members that we packaged the costs associated
with radiologic injection codes into the radiological supervision and
interpretation codes with which they were reported. The reason for
doing this is that hospitals incur expenses for providing both services
and they typically perform both an injection and a supervision and
interpretation procedure on the same patient. Therefore, since neither
an injection code nor a supervision and interpretation code should be
billed alone, it would not be appropriate for us to use single claims
data to determine the costs of performing these procedures. However, we
are using single claims data in order to accurately
[[Page 44684]]
determine the costs of performing procedures. Therefore, in order to
accurately determine the costs of a complete radiologic procedure, we
had to package the costs of the injection component into the cost of
the supervision and interpretation component with which it was billed.
The Panel believed that, in 1996, hospitals generally did not bill the
injection code when performing myelography. Furthermore, in 1996, some
hospitals kept patients overnight after a myelogram. More recently,
postmyelogram recovery time has decreased to about 6 hours. For these
reasons, the Panel believed that the median costs of $109 and $174
probably do not represent the actual resources used for CPT codes
70010, Myelography, posterior fossa, radiological supervision and
interpretation, and 70015, Cisternography, positive contrast,
radiological supervision and interpretation. Therefore, the Panel
recommended the following:
Make no changes to APC 0274.
Review new cost data to determine whether payment would
increase for APC 0274.
We propose to accept the Panel's recommendations.
APC 0279: Level I Diagnostic Angiography and Venography
APC 0280: Level II Diagnostic Angiography and Venography
We presented these codes to the Panel for several reasons. APC 0279
fails the 2 times rule, there are numerous codes in these APCs with no
cost data, there are numerous ``add on'' codes in these APCs, and many
of these procedures were performed infrequently in the outpatient
setting in 1996.
The Panel reviewed the clinical coherence of both APCs as well as
the resources required to perform all these procedures. The Panel
believed that it would be unusual for many of these procedures to be
performed separately and that we would need to look at multiple claims
to get accurate data. The Panel recommended the following:
Create a new APC (APC 0287, Complex Venography) with the
following CPT codes: 75831, 75840, 75842, 75860, 75870, 75872, and
75880.
Move CPT codes 75960, 75961, 75964, 75968, 75970, 75978,
75992, and 75995 from APC 0279 to APC 0280.
We propose to accept the Panel's recommendations. We note that, as
proposed, APC 0279 violates the 2 times rule because of the low cost
data for CPT code 75660, Angiography, external carotid, unilateral
selective, radiological supervision and interpretation. We believe
that, for these procedures, these cost data are aberrant. This code is
clinically similar to the other codes in APC 0279 and moving code 75660
to an APC with a lower weight could be an inappropriate APC assignment.
Therefore, we believe that an exception to the 2 times rule is
warranted.
APC 0300: Level I Radiation Therapy
APC 0302: Level III Radiation Therapy
We presented this APC to the Panel because we received comments
that the assignment of CPT code 61793, Stereotactic radiosurgery
(particle beam, gamma ray, or linear accelerator), one or more
sessions, to APC 0302 would result in inappropriate payment of this
service. Many commenters wrote that stereotactic radiosurgery and
intensity modulated radiation therapy (IMRT) required significantly
more staff time, treatment time, and resources than other types of
radiation therapy. Other commenters disagreed with our decision,
effective January 1, 2001, to discontinue recognizing CPT code 61793,
and to create two HCPCS level 2 codes, G0173, Stereotactic
radiosurgery, complete course of therapy in one session, and G0174
Intensity modulated radiation therapy (IMRT) plan, per session, to
report both stereotactic radiosurgery and IMRT.
We reported to the Panel that the APC assignment of these G codes
and their payment rate was based on our understanding that stereotactic
radiosurgery was generally performed on an inpatient basis and
delivered a complete course of treatment in a single session, while
IMRT was performed on an outpatient basis and required several sessions
to deliver a complete course of treatment. We also explained to the
Panel that it was our understanding that multiple CPT codes were billed
for each session of stereotactic radiosurgery and IMRT. Therefore, we
believed that the payment for APC 0302 was only a fraction of the total
payment a hospital received for performing stereotactic radiosurgery or
IMRT on an outpatient basis.
Radiosurgery equipment manufacturers, physician groups, and patient
advocacy groups have both submitted comments to us and provided
testimony to the APC Panel on these issues. These comments have
convinced us that we did not clearly understand either the relationship
of IMRT to stereotactic radiosurgery or the various types of equipment
used to perform these services.
We are proposing to set forth a proposed new coding structure that
more accurately reflects the clinical use of these services and the
resources required to perform them. Our understanding of these
services, based on review of the comments, the testimony before the
Panel, the Panel discussion and recommendations, and meetings with
knowledgeable stakeholders, is described below.
Recent developments in the field of radiation oncology include the
ability to deliver high doses of radiation to abnormal tissues (e.g.,
tumors) while minimizing delivery of radiation to adjacent normal
tissues. Collectively, these procedures are called stereotactic
radiosurgery and IMRT.
Clinically, there are essentially two services required to deliver
stereotactic radiosurgery and IMRT. First, there is ``treatment
planning,'' which includes such activities as determining the location
of all normal and abnormal tissues, determining the amount of radiation
to be delivered to the abnormal tissue, determining the dose tolerances
of normal tissues, and determining how to deliver the required dose to
abnormal tissue while delivering a dose to adjacent normal tissues
within their range of tolerance. These activities include the ability
to manufacture various treatment devices for protection of normal
tissue as well as the ability to ensure that the plan will deliver the
intended doses to normal and abnormal tissue by simulating the
treatment. Second, there is ``treatment delivery,'' which is the actual
delivery of radiation to the patient in accordance with the treatment
plan. Treatment delivery includes such activities as adjusting the
collimator (a device that filters the radiation beams), doing setup and
verification images, treating one or more areas, and performing quality
control.
Treatment planning requires specialized equipment including a
duplicate of the actual equipment used to deliver the treatment, the
ability to perform a CT scan, various disposable supplies, and
involvement of various staff such as the physician, the physicist, the
dosimetrist, and the radiation technologist. Treatment delivery
requires specialized equipment to deliver the treatment and the
involvement of the radiation technologist. The physician and physicist
provide general oversight of this process.
Although there are several types of equipment, produced by several
manufacturers, used to accomplish this treatment, it is the consensus
of the commenters and the Panel that the most useful way to categorize
stereotactic radiosurgery and IMRT is by the source of radiation used
for the treatment and
[[Page 44685]]
not by the type of equipment used. One reason for this is that the
clinical indications for stereotactic radiosurgery and IMRT overlap.
Therefore, a single disease process can be treated by either modality
but the cost of treatment varies by source of radiation used for the
treatment. Second, while both stereotactic radiosurgery and IMRT can
deliver a complete course of treatment in either one or multiple
sessions, the cost of treatment delivery per session is relatively
fixed, and is closely related to the source of radiation used for the
treatment. Therefore, we believe that appropriate APC assignment and
payment can be made by creating a small number of HCPCS codes to
describe these services. The proposed codes are as follows:
GXXX1 Multi-source photon stereotactic radiosurgery
(Cobalt 60 multi-source converging beams) plan, including dose volume
histograms for target and critical structure tolerances, plan
optimization performed for highly conformal distributions, plan
positional accuracy and dose verification, all lesions treated, per
course of treatment.
GXXX2 Multi-source photon stereotactic radiosurgery,
delivery including collimator changes and custom plugging, complete
course of treatment, per lesion.
G0174 Intensity modulated radiation therapy (IMRT)
delivery to one or more treatment areas, multiple couch angles/fields/
arcs custom collimated pencil-beams with treatment setup and
verification images, complete course of therapy requiring more than one
session, per session.
G0178 Intensity modulated radiation therapy (IMRT) plan,
including dose volume histograms for target and critical structure
partial tolerances, inverse plan optimization performed for highly
conformal distributions, plan positional accuracy and dose
verification, per course of treatment.
We propose that HCPCS codes GXXX1, G0174, and G0178 have status
indicators of S, while GXXX2 have a status indicator of T. We believe
these are the correct status indicators because G0178 has a ``per
session'' designation, while GXXX2 has a ``per lesion'' designation.
Furthermore, it is our understanding that GXXX1 would not be billed on
a ``per lesion'' basis as the planning process would take into account
all lesions being treated and it would be extremely difficult to
determine resource utilization for planning on a ``per lesion'' basis.
Because the costs of performing GXXX1 will vary based on the number of
lesions treated, payment would reflect a weighted average.
It is our understanding that single-source photon stereotactic
radiosurgery (or LINAC) planning and delivery are similar to IMRT
planning and delivery in terms of clinical use and resource
requirements. Therefore, we propose to require coding for single-source
photon stereotactic radiosurgery under HCPCS codes G0174 and G0178.
Further, we are aware that the AMA is establishing codes for IMRT
planning and treatment delivery for 2002 and we propose to retire G0174
and G0178 (with the usual 90-day phase out) and recognize the
applicable CPT codes when they are established in January 2002.
We believe that all activities required to perform stereotactic
radiosurgery and IMRT are included in the codes described above. In
order to avoid confusion and to optimize tracking of these services in
terms of both utilization and cost, we propose to discontinue the use
of any other radiation therapy codes for activities involved with
planning and delivery of stereotactic radiosurgery and IMRT for
purposes of hospital billing in OPPS. Thus, we would continue to not
recognize CPT code 61793 for hospital billing purposes.
We believe the coding requirements set forth above not only
simplify the reporting process for hospitals, but appropriately
recognize the clinical practice and resource requirements for
stereotactic radiosurgery and IMRT.
We seek comments on our proposal, including the code titles,
descriptors, and coding requirements discussed above. We also request
information regarding appropriate APC assignment and payment rates to
inform our decision-making. In particular, we would like information
regarding the costs of treatment delivery including any differences
between the cost of a complete treatment in single versus multiple
sessions.
We also note that several commenters requested placement of the
stereotactic delivery codes in surgical APCs and we request
clarification and support for these comments within the context of our
coding proposal. Specifically, we are concerned that appropriate
payment be made for GXXX2, which has a ``per lesion'' descriptor.
We believe that while the APC Panel did not make any specific
recommendations regarding these codes, the concerns expressed by the
Panel are addressed by our proposal.
APC 0311: Radiation Physics Services
APC 0312: Radio Element Application
APC 0313: Brachytherapy
We presented APC 0311 to the Panel because we believed our cost
data for CPT codes 77336, Continuing medical physics consultation,
including assessment of treatment parameters, quality assurance of dose
delivery, and review of patient treatment documentation in support of
the radiation oncologist, reported per week of therapy; 77370, Special
medical radiation physics consultation; and 77399, Unlisted procedure,
medical radiation physics, dosimetry, and treatment devices, and
special services, were inaccurate. We were concerned that these
procedures, particularly code 77370, were not being paid appropriately
in APC 0311.
Presenters pointed out that, as with all radiation oncology
services, the usual practice is to bill multiple CPT codes on the same
date of service. Therefore, single claims were likely to be inaccurate
bills and did not represent the true costs of the procedure. For this
reason, presenters believe that using single claims to set payment
rates for radiation oncology procedures was inappropriate and that we
needed to develop a methodology that allowed the use of multiple claims
data to set payment rates for these services.
With regard to radiation physics consultation, presenters stated
that the staff costs associated with CPT code 77370 were significantly
greater than the costs of CPT codes 77336 and 77399. Therefore, they
recommended that CPT codes 77336 and 77399 be moved from APC 0311 to
APC 0304, Level I Therapeutic Radiation Treatment Preparation, and CPT
code 77370 be moved from APC 0311 to APC 0305, Level II Therapeutic
Radiation Treatment Preparation. The Panel agreed with this
recommendation and we propose to accept the Panel's recommendation. We
also agree that we should review the use of single claims to set
payment rates for radiation oncology services. We plan to present this
issue again at the 2002 Panel meeting.
We presented APCs 0312 and 0313 to the Panel because commenters
were concerned that the payment rates were too low for the procedures
assigned to the APCs and that there were insufficient data to set
payment rates for these APCs. The Panel agreed that the issue regarding
the use of single claim data affected the payment rates for these
services. However, there were insufficient data for the Panel to make
[[Page 44686]]
any recommendations regarding these APCs. The Panel did request to look
at the issue of radiation oncology at its 2002 meeting.
Therefore, we are proposing to make no changes to APCs 0312 and
0313 but will address radiation oncology issues at the Panel's 2002
meeting. We note that our updated claims data show very few single
claims for procedures in these APCs. However, moving any of these
procedures into other radiation oncology APCs would lower their payment
rates.
APC 0371: Allergy Injections
We presented this APC to the Panel because it violates the 2 times
rule. The median costs for CPT codes 95115, Professional Services for
allergen immunotherapy not including provision of allergenic extracts;
single injection, and 95117, Professional Services for allergen
immunotherapy not including provision of allergenic extracts; two or
more injections, were lower than the median costs for the other
services in this APC.
The Panel agreed that because codes 95115 and 95117 included
administration of an injection only, the resource utilization for these
services was lower than for the other services. The other services
involve preparation of antigen and require more staff time and hospital
resources to perform.
In order to create clinical and resource homogeneity, the Panel
recommended that we create a new APC for codes 95115 and 95117 and that
we leave the other services in APC 0371. We propose to accept the Panel
recommendation and create a new APC 0353, Level II Allergy Injections,
and revise the title of APC 0371 to Level I Allergy Injections.
Observation Services
See the discussion on observation services in section II.C.4 of
this preamble for a summary of the Panel discussion and recommendations
and our proposal.
Inpatient Procedure List
See the discussion of the inpatient procedures list in section
II.C.5 of this preamble for a summary of the Panel discussion and
recommendations and our proposal.
B. Additional APC Changes Resulting from BIPA Provisions
1. Coverage of Glaucoma Screening
Section 102 of the BIPA amended section 1861(s)(2) of the Act to
provide payment for glaucoma screening for eligible Medicare
beneficiaries, specifically, those with diabetes mellitus or a family
history of glaucoma, and certain other individuals found to be at high
risk for glaucoma as specified by our rulemaking. The implementation of
this provision is discussed in detail in a separate proposed rule
concerning the revisions in the physician payment policy for CY 2002.
In order to implement section 102 of BIPA, we have established two
new HCPCS codes for glaucoma screening:
G0117--Glaucoma screening for high risk patients furnished by an
ophthalmologist or optometrist.
G0118--Glaucoma screening for high risk patients furnished under
the direct supervision of an ophthalmologist or optometrist.
We are proposing to assign the glaucoma screening codes to APC
0230, Level I Eye Tests. We further propose to instruct our fiscal
intermediaries to make payment for glaucoma screening only if it is the
sole ophthalmologic service for which the hospital submits a bill for a
visit. That is, the services included in glaucoma screening (a dilated
eye examination with an intraocular pressure measurement and direct
opthalmoscopy or slit-lamp biomicroscopy) would generally be performed
during the delivery of another opthalmologic service that is furnished
on the same day. If the beneficiary receives only a screening service,
however, we would pay for it under APC 0230.
2. APCs for Contrast Enhanced Diagnostic Procedures
Section 430 of the BIPA amended section 1833(t)(2) of the Act to
require the Secretary to create additional APC groups to classify
procedures that utilize contrast agents separately from those that do
not, effective for items and services furnished on or after July 1,
2001. On June 1, 2001, we issued a Program Memorandum, Transmittal A-
01-73, in which we made numerous coding and grouping changes to
implement this provision. (This transmittal can be found at
www.hcfa.gov/pubforms/transmit/AO173.pdf) We removed the radiological
procedures whose descriptors included either ``without contrast
material'' or ``without contrast material followed by contrast
material'' from APC groups 0282, Level I, Computerized Axial
Tomography; APC 0283, Level II, Computerized Axial Tomography; and APC
0284, Magnetic Resonance Imaging. As a result, APCs 0283 and 0284 now
include only imaging procedures that are performed with contrast
materials. Additionally, reconfigured APC 0282 no longer includes
radiological procedures that use contrast agents.
Effective for items or services furnished on or after July 1, 2001,
we created six new APC groups for the procedures removed from APCs
0282, 0283, and 0284, as shown below. (Effective October 1, 2001, we
will eliminate APC 0338. Refer to Transmittal A-01-73 for a detailed
description of this change.) For services furnished on or after July 1,
2001 and before January 1, 2002, the payment rates for the new imaging
APCs are the same as those associated with the APCs from which the
procedures were moved. In this proposed rule, the weights for the new
APCs are recalibrated based on the data we are using to set the weights
for 2002.
Table 1.--APC Groups Reconfigured to Separate Imaging Procedures That
Use Contrast Material From Procedures That Do Not Use Contrast Material
------------------------------------------------------------------------
APC SI APC title
------------------------------------------------------------------------
0282...................... S Miscellaneous Computerized
Axial Tomography.
0283...................... S Computerized Axial
Tomography with Contrast.
0284...................... S Magnetic Resonance Imaging
and Angiography with
Contrast.
0332...................... S Computerized Axial
Tomography w/o Contrast.
0333...................... S CT Angio and Computerized
Axial Tomography w/o
Contrast followed by with
Contrast.
0335...................... S Magnetic Resonance
Imaging,
Temporomandibular Joint.
0336...................... S Magnetic Resonance
Angiography and Imaging
without Contrast.
0337...................... S Magnetic Resonance Imaging
and Angiography w/o
Contrast followed by with
Contrast.
0338...................... S Magnetic Resonance
Angiography, Chest and
Abdomen with or w/o
Contrast.
------------------------------------------------------------------------
The HCPCS codes that are reassigned to the new imaging APCs in this
proposed rule are as follows:
[[Page 44687]]
------------------------------------------------------------------------
APC HCPCS SI Short descriptor
------------------------------------------------------------------------
0282................. 76370 S CAT scan for therapy
guide.
76375 S 3d/holograph
reconstr add-on.
76380 S CAT scan for follow-
up study.
G0131 S Ct scan, bone
density study.
G0132 S Ct scan, bone
density study.
0283................. 70460 S Ct head/brain w/dye.
70481 S Ct orbit/ear/fossa w/
dye.
70487 S Ct maxillofacial w/
dye.
70491 S Ct soft tissue neck
w/dye.
71260 S Ct thorax w/dye.
72126 S Ct neck spine w/dye.
72129 S Ct chest spine w/
dye.
72132 S Ct lumbar spine w/
dye.
72193 S Ct pelvis w/dye.
73201 S Ct upper extremity w/
dye.
73701 S Ct lower extremity w/
dye.
74160 S Ct abdomen w/dye.
76355 S CAT scan for
localization.
76360 S CAT scan for needle
biopsy.
0284................. 70542 S MRI orbit/face/neck
w/dye.
70545 S Mr angiography head
w/dye.
70548 S Mr angiography neck
w/dye.
70552 S MRI brain w/dye.
71551 S MRI chest w/dye.
72142 S MRI neck spine w/
dye.
72147 S MRI chest spine w/
dye.
72149 S MRI lumbar spine w/
dye.
72196 S MRI pelvis w/dye.
73219 S MRI upper extremity
w/dye.
73222 S MRI joint upr extrem
w/dye.
73719 S MRI lower extremity
w/dye.
73722 S MRI joint of lwr
extr w/dye.
74182 S MRI abdomen w/dye.
75553 S Heart MRI for morph
w/dye.
C8900 S MRA w/cont, abd.
C8903 S MRI w/cont, breast,
uni.
C8906 S MRI w/cont, breast,
bi.
C8909 S MRA w/cont, chest.
C8912 S MRA w/cont, lwr ext.
0332................. 70450 S CAT scan of head or
brain.
70480 S Ct orbit/ear/fossa w/
o dye.
70486 S Ct maxillofacial w/o
dye.
70490 S Ct soft tissue neck
w/o dye.
71250 S Ct thorax w/o dye.
72125 S Ct neck spine w/o
dye.
72128 S Ct chest spine w/o
dye.
72131 S Ct lumbar spine w/o
dye.
72192 S Ct pelvis w/o dye.
73200 S Ct upper extremity w/
o dye.
73700 S Ct lower extremity w/
o dye.
74150 S Ct abdomen w/o dye.
0333................. 70470 S Ct head/brain w/o&w
dye.
70482 S Ct orbit/ear/fossa w/
o&w dye.
70488 S Ct maxillofacial w/
o&w dye.
70492 S Ct sft tsue nck w/o
& w/dye.
70496 S Ct angiography,
head.
70498 S Ct angiography,
neck.
71270 S Ct thorax w/o&w dye.
71275 S Ct angiography,
chest.
72127 S Ct neck spine w/o&w
dye.
72130 S Ct chest spine w/o&w
dye.
72133 S Ct lumbar spine w/
o&w dye.
72191 S Ct angiograph pelv w/
o&w dye.
72194 S Ct pelvis w/o&w dye.
73202 S Ct uppr extremity w/
o&w dye.
73206 S Ct angio upr extrm w/
o&w dye.
73702 S Ct lwr extremity w/
o&w dye.
73706 S Ct angio lwr extr w/
o&w dye.
74170 S Ct abdomen w/o&w
dye.
74175 S Ct angio abdom w/o&w
dye.
75635 S Ct angio abdominal
arteries.
0335................. 70336 S Magnetic image, jaw
joint.
75554 S Cardiac mri/
function.
75555 S Cardiac mri/limited
study.
[[Page 44688]]
76390 S Mr spectroscopy.
76400 S Magnetic image, bone
marrow.
0336................. 70540 S MRI orbit/face/neck
w/o dye.
70544 S Mr angiography head
w/o dye.
70547 S Mr angiography neck
w/o dye.
70551 S MRI brain w/o dye.
71550 S MRI chest w/o dye.
72141 S MRI neck spine w/o
dye.
72146 S MRI chest spine w/o
dye.
72148 S MRI lumbar spine w/o
dye.
72195 S MRI pelvis w/o dye.
73218 S MRI upper extremity
w/o dye.
73221 S MRI joint upr extrem
w/o dye.
73718 S MRI lower extremity
w/o dye.
73721 S MRI joint of lwr
extre w/o dye.
74181 S MRI abdomen w/o dye.
75552 S Heart MRI for morph
w/o dye.
C8901 S MRA w/o cont, abd.
C8904 S MRI w/o cont,
breast, uni.
C8910 S MRA w/o cont, chest.
C8913 S MRA w/o cont, lwr
ext.
0337................. 70543 S MRI orbt/fac/nck w/
o&w dye.
70546 S Mr angiograph head w/
o&w dye.
70549 S Mr angiograph neck w/
o&w dye.
70553 S MRI brain w/o&w dye.
71552 S MRI chest w/o&w dye.
72156 S MRI neck spine w/o&w
dye.
72157 S MRI chest spine w/
o&w dye.
72158 S MRI lumbar spine w/
o&w dye.
72197 S MRI pelvis w/o&w
dye.
73220 S MRI uppr extremity w/
o&w dye.
73223 S MRI joint upr extr w/
o&w dye.
73720 S MRI lwr extremity w/
o&w dye.
73723 S MRI joint lwr extr w/
o&w dye.
74183 S MRI abdomen w/o&w
dye.
C8902 S MRA w/o fol w/cont,
abd.
C8905 S MRI w/o fol w/cont,
brst, uni.
C8908 S MRI w/o fol w/cont,
breast, bi.
C8911 S MRA w/o fol w/cont,
chest.
C8914 S MRA w/o fol w/cont,
lwr ext.
------------------------------------------------------------------------
Refer to Addendum A or Addendum B for the updated weights, payment
rates, national unadjusted copayment, and minimum unadjusted copayment
that we are proposing for all of the procedures listed above.
C. Other Changes Affecting the APCs
1. Changes in Revenue Code Packaging
In the April 7, 2000 final rule, we described how, in calculating
the per procedure and per visit costs to determine the median cost of
an APC (and therefore its relative weight), we used the charges billed
using the revenue codes that contained items that were integral to
performing the procedure or visit (65 FR 18483). For example, in
calculating the cost of a surgical procedure, we included charges for
revenue codes such as operating room, treatment rooms, recovery,
observation, medical and surgical supplies, pharmacy, anesthesia, casts
and splints, and donor tissue, bone, and organ. For medical visit
costs, we included charges for items such as medical and surgical
supplies, drugs, and observation. The complete list of the revenue
centers by type of APC group was printed in the April 7, 2000 rule (65
FR 18484).
In the November 13, 2000 interim final rule, we made some changes
to the list of revenue codes to reflect the charges associated with
implantable devices (65 FR 67806 and 67825). As we stated in that rule,
charges included in revenue codes 274 (prosthetic/orthotic devices),
275 (pacemaker), and 278 (other implants) were not included in the
initial APC payment rates because, before enactment of BBRA, we were
proposing to pay these devices outside of the OPPS, and, after the
enactment of the BBRA, it was not feasible to revise our database to
include these revenue codes in developing the April 7, 2000 final rule.
As discussed i