[Federal Register: November 2, 1998 (Volume 63, Number 211)]
[Rules and Regulations]               
[Page 58813-58862]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no98-16]
 

[[Page 58813]]

_______________________________________________________________________

Part II





Department of Health and Human Services





_______________________________________________________________________



Health Care Financing Administration



_______________________________________________________________________



42 CFR Part 405, et al.



Medicare Program; Revisions to Payment Policies and Adjustments to the 
Relative Value Units Under the Physician Fee Schedule for Calendar Year 
1999; Final Rule and Notice


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 405, 410, 413, 414, 415, 424, and 485

[HCFA-1006-FC]
RIN 0938-AI52

 
Medicare Program; Revisions to Payment Policies and Adjustments 
to the Relative Value Units Under the Physician Fee Schedule for 
Calendar Year 1999

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

-----------------------------------------------------------------------

SUMMARY: This final rule makes several policy changes affecting 
Medicare Part B payment. The changes that relate to physicians' 
services include: resource-based practice expense relative value units 
(RVUs), medical direction rules for anesthesia services, and payment 
for abnormal Pap smears. Also, we are rebasing the Medicare Economic 
Index from a 1989 base year to a 1996 base year. Under the law, we are 
required to develop a resource-based system for determining practice 
expense RVUs. The Balanced Budget Act of 1997 (BBA) delayed, for 1 
year, implementation of the resource-based practice expense RVUs until 
January 1, 1999. Also, BBA revised our payment policy for nonphysician 
practitioners, for outpatient rehabilitation services, and for drugs 
and biologicals not paid on a cost or prospective payment basis. In 
addition, BBA permits certain physicians and practitioners to opt out 
of Medicare and furnish covered services to Medicare beneficiaries 
through private contracts and permits payment for professional 
consultations via interactive telecommunication systems. Furthermore, 
we are finalizing the 1998 interim RVUs and are issuing interim RVUs 
for new and revised codes for 1999. This final rule also announces the 
calendar year 1999 Medicare physician fee schedule conversion factor 
under the Medicare Supplementary Medical Insurance (Part B) program as 
required by section 1848(d) of the Social Security Act. The 1999 
Medicare physician fee schedule conversion factor is $34.7315.

DATES: Effective date: This rule this rule is effective January 1, 
1999.
    Applicability date: Part 405 subpart D is applicable for private 
contract affidavits signed and private contracts entered into on or 
after January 1, 1999.
    This rule is a major rule as defined in Title 5, United States 
Code, section 804(2). Pursuant to 5 U.S.C. section 801(a)(1)(A), we are 
submitting a report to the Congress on this rule on October 30, 1998.
    Comment date: We will accept comments on interim RVUs for selected 
procedure codes identified in Addendum C and on interim practice 
expense RVUs for all codes as shown in Addendum B. Comments will be 
considered if we receive them at the appropriate address, as provided 
below, no later than 5 p.m. on January 4, 1999.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-1006-FC, P.O. Box 26688, 
Baltimore, MD 21207-0488.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-1006-FC. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 443-G of 
the Department's offices at 200 Independence Avenue, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
(phone: (202) 690-7890).

FOR FURTHER INFORMATION CONTACT:

Roberta Epps, (410) 786-4503 (for issues related to outpatient 
rehabilitation services).
Stephen Heffler, (410) 786-1211 (for issues related to the Medicare 
Economic Index).
Anita Heygster, (410) 786-4486 (for issues related to private 
contracts).
Jim Menas, (410) 786-4507 (for issues related to Pap smears and medical 
direction for anesthesia services).
Robert Niemann, (410) 786-4569 (for issues related to the drugs and 
biologicals policy).
Regina Walker-Wren, (410) 786-9160 (for issues related to physician 
assistants, nurse practitioners, clinical nurse specialists, and 
certified nurse-midwives).
Craig Dobyski, (410) 786-4584 (for issues related to 
teleconsultations).
Stanley Weintraub, (410) 786-4498 (for issues related to practice 
expense relative value units and all other issues).

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guest (no password required).
    To assist readers in referencing sections contained in this 
preamble, we are providing the following table of contents. Some of the 
issues discussed in this preamble affect the payment policies but do 
not require changes to the regulations in the Code of Federal 
Regulations. Information on the regulation's impact appears throughout 
the preamble and not exclusively in part IX.

Table of Contents

I. Background
    A. Legislative History
    B. Published Changes to the Fee Schedule
II. Specific Proposals for Calendar Year 1998; Response to Comments
    A. Resource-Based Practice Expense Relative Value Units
    1. Resource-Based Practice Expense Legislation
    2. Proposed Methodology for Computing Practice Expense Relative 
Value Units
    3. Other Practice Expense Policies

[[Page 58815]]

    4. Refinement of Practice Expense Relative Value Units
    5. Reductions in Practice Expense Relative Value Units for 
Multiple Procedures
    6. Transition
    B. Medical Direction for Anesthesia Services
    C. Separate Payment for a Physician's Interpretation of an 
Abnormal Papanicolaou Smear
    D. Rebasing and Revising the Medicare Economic Index
III. Implementation of the Balanced Budget Act
    A. Payment for Drugs and Biologicals
    B. Private Contracting with Medicare Beneficiaries
    C. Payment for Outpatient Rehabilitation Services
    1. BBA 1997 Provisions Affecting Payment for Outpatient 
Rehabilitation Services
    a. Reasonable Cost-Based Payments
    b. Prospective Payment System for Outpatient Rehabilitation 
Services
    (1) Overview
    (2) Services Furnished by Skilled Nursing Facilities
    (3) Services Furnished by Home Health Agencies
    (4) Services Furnished by Comprehensive Outpatient 
Rehabilitation Facilities
    (5) Site-of-Service Differential
    (6) Mandatory Assignment
    2. Uniform Procedure Codes for Outpatient Rehabilitation 
Services
    3. Financial Limitation
    a. Overview
    b. Use of Modifiers to Track the Financial Limitation
    c. Treatment of Services Exceeding the Financial Limitation
    4. Qualified Therapists
    5. Plan of Treatment
    D. Payment for Services of Certain Nonphysician Practitioners 
and Services Furnished Incident to their Professional Services
    E. Payment for Teleconsultations in Rural Health Professional 
Shortage Areas
IV. Refinement of Relative Value Units for Calendar Year 1999 and 
Responses to Public Comments on Interim Relative Value Units for 
1998
    A. Summary of Issues Discussed Related to the Adjustment of 
Relative Value Units
    B. Process for Establishing Work Relative Value Units for the 
1999 Fee Schedule
V. Physician Fee Schedule Update and Conversion Factor for Calendar 
Year 1999
VI. Provisions of the Final Rule
VII. Collection of Information Requirements
VIII. Regulatory Impact Analysis
    A. Regulatory Flexibility Act
    B. Resource-Based Practice Expense Relative Value Units
    C. Medical Direction for Anesthesia Services
    D. Separate Payment for a Physician's Interpretation of an 
Abnormal Papanicolaou Smear
    E. Rebasing and Revising the Medicare Economic Index
    F. Payment for Nurse Midwives' Services
    G. BBA Provisions Included in This Proposed Rule
    H. Impact on Beneficiaries
Addendum A--Explanation and Use of Addenda B and C
Addendum B--Relative Value Units (RVUs) and Related Information
Addendum C--Codes with Interim RVUs

    In addition, because of the many organizations and terms to which 
we refer by acronym in this final rule, we are listing these acronyms 
and their corresponding terms in alphabetical order below:

AANA: American Association of Nurse Anesthetists
ABC: Activity based costing
ABN: Advance Beneficiary Notice
AHE: Average hourly earnings
AMA: American Medical Association
ANCC: American Nurses Credentialing Center
ASA: American Society of Anesthesiologists
ASOPA: American Society of Orthopedic Physician Assistants
AWP: Average wholesale price
BBA: Balanced Budget Act of 1997
BLS: Bureau of Labor Statistics
CAAHEP: Commission on Accreditation of Allied Health Education 
Programs
CF: Conversion factor
CFR: Code of Federal Regulations
CMSAs: Consolidated Metropolitan Statistical Areas
CORF: Comprehensive outpatient rehabilitation facility
CPEPs: Clinical Practice Expert Panels
CPI: Consumer Price Index
CPI-U: Consumer Price Index for All Urban Consumers
CPS: Current Population Survey
CPT: [Physicians'] Current Procedural Terminology
CRNA: Certified Registered Nurse Anesthetist
DME: Durable medical equipment
DMEPOS: Durable medical equipment, prosthetics, orthotics, and 
supplies
DRG: Diagnosis-related group
EAC: Estimated acquisition cost
ECI: Employment Cost Index
ES-202 Data: Bureau of Labor Statistics from State unemployment 
insurance agencies
ESRD: End-stage renal disease
FDA: Food and Drug Administration
FMR: Fair market rental
FQHC: Federally qualified health center
GAAP: Generally accepted accounting principles
GAF: Geographic adjustment factor
GPCI: Geographic practice cost index
HCFA: Health Care Financing Administration
HCPAC: Health Care Professionals Advisory Committee
HCPCS: HCFA Common Procedure Coding System
HHA: Home health agency
HHS: [Department of] Health and Human Services
HMO: Health maintenance organization
HPSA: Health professional shortage area
HRSA: Health Resources and Services Administration
HUD: [Department of] Housing and Urban Development
IPLs: Independent Physiologic Laboratories
MedPAC: Medicare Payment Advisory Commission
MEI: Medicare Economic Index
MGMA: Medical Group Management Association
MSA: Metropolitan Statistical Area
MSA: Medicare Supplemental Insurance
MVPS: Medicare volume performance standard
NAIC: National Association of Insurance Commissioners
NBCOPA: National Board on Certification for Orthopedic Physician 
Assistants
NCCPA: National Council on Certification of Physician Assistants
NPI: National provider identifier
OBRA: Omnibus Budget Reconciliation Act
OTIP: Occupational therapist in independent practice
PC: Professional component
PHS: Public Health Service
PMSA: Primary Metropolitan Statistical Area
PPI: Producer price index
PPS: Prospective payment system
PTIP: Physical therapist in independent practice
RBRVS: Resource Based Relative Value Scale
RHC: Rural health clinic
RUC: [AMA's Specialty Society] Relative [Value] Update Committee
RN: Registered nurse
RVU: Relative value unit
SMS: Socioeconomic Monitoring System
SNF: Skilled nursing facility
TC: Technical component
TEFRA: Tax Equity and Fiscal Responsibility Act
UPIN: Uniform provider identifier number

I. Background

A. Legislative History

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Social Security Act (the Act), ``Payment for 
Physicians' Services.'' This section contains three major elements: (1) 
A fee schedule for the payment of physicians' services; (2) a 
sustainable growth rate for the rates of increase in Medicare 
expenditures for physicians' services; and (3) limits on the amounts 
that nonparticipating physicians can charge beneficiaries. The Act 
requires that payments under the fee schedule be based on national 
uniform relative value units (RVUs) based on the resources used in 
furnishing a service. Section 1848(c) of the Act requires that national 
RVUs be established for physician work, practice expense, and 
malpractice expense.
    Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments 
in RVUs because of changes resulting from a review of those RVUs may 
not cause total physician fee schedule payments to differ by more than 
$20 million from what they would have been had the adjustments not been 
made. If this tolerance is exceeded, we must make adjustments to the 
conversion factors (CFs) to preserve budget neutrality.

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B. Published Changes to the Fee Schedule

    In the June 5, 1998, proposed rule (63 FR 30820), we listed all of 
the final rules published through October 31, 1997 relating to the 
updates to the RVUs and revisions to payment policies under the 
physician fee schedule. In the June 5, 1998 proposed rule (63 FR 
30818), we discussed several policy options affecting Medicare payment 
for physicians' services including resource-based practice expense 
RVUs, medical direction rules for anesthesia services, and payment for 
abnormal Pap smears. Also, we discussed the rebasing of the Medicare 
Economic Index from a 1989 base year to a 1996 base year. Further, 
based on BBA, we proposed revising our payment policy for nonphysician 
practitioners, for outpatient rehabilitation services, and for drugs 
and biologicals not paid on a cost or prospective payment basis. In 
addition, based on BBA, we discussed implementing new payment policies 
for certain physicians and practitioners who opt out of Medicare and 
furnish covered services to Medicare beneficiaries through private 
contracts. And finally, based on BBA, we discussed teleconsultation 
services.
    This final rule affects the regulations set forth at 42 CFR part 
405, which consists of regulations on Federal health insurance for the 
aged and disabled; part 410, which consists of regulations on 
supplementary medical insurance benefits; part 414, which consists of 
regulations on the payment for Part B medical and other health 
services; part 415, which pertains to services furnished by physicians 
in providers, supervising physicians in teaching settings, and 
residents in certain settings; part 424, which pertains to the 
conditions for Medicare payment; and part 485, which pertains to 
conditions of participation: specialized providers.

II. Specific Proposals for Calendar Year 1998; Response to Comments

    In response to the publication of the June 5, 1998 proposed rule, 
we received approximately 14,000 comments. We received comments from 
individual physicians, health care workers, and professional 
associations and societies. The majority of the comments addressed the 
proposal related to the resource-based practice expense policy.
    The proposed rule discussed policies that affect the number of RVUs 
on which payment for certain services would be based. Certain changes 
implemented through this final rule are subject to the $20 million 
limitation on annual adjustments contained in section 
1848(c)(2)(B)(ii)(II) of the Act.
    After reviewing the comments and determining the policies we will 
implement, we have estimated the costs and savings of these policies 
and added those costs and savings to the estimated costs associated 
with any other changes in RVUs for 1999. We discuss in detail the 
effects of these changes in the Regulatory Impact Analysis (section 
IX).
    For the convenience of the reader, the headings for the policy 
issues in this section correspond to the headings used in the June 5, 
1998 proposed rule. More detailed background information for each issue 
can be found in the June 5, 1998 proposed rule.

A. Resource-Based Practice Expense Relative Value Units

1. Resource-Based Practice Expense Legislation
    Section 121 of the Social Security Act Amendments of 1994 (Public 
Law 103-432), enacted on October 31, 1994, required us to develop a 
methodology for determining resource-based practice expense RVUs for 
each physician's service that would be effective for services furnished 
in 1998. In developing the methodology, we were required to consider 
the staff, equipment, and supplies used in providing medical and 
surgical services in various settings.
    The legislation specifically required that, in implementing the new 
system of practice expense RVUs, we apply the same budget-neutrality 
provisions that we apply to other adjustments under the physician fee 
schedule.
    On August 5, 1997, the President signed the BBA into law. Section 
4505(a) of BBA delayed the effective date of the resource-based 
practice expense RVU system until January 1, 1999. In addition, BBA 
provided for the following revisions in the requirements to change from 
a charge-based practice expense RVU system to a resource-based method.
    Instead of paying for all services entirely under a resource-based 
system in 1999, section 4505(b) of BBA provided for a 4-year transition 
period. The practice expense RVUs for the year 1999 will be the product 
of 75 percent of charge-based RVUs (1998) and 25 percent of the 
resource-based RVUs. For the year 2000, the percentages will be 50 
percent charge-based and 50 percent resource-based. For the year 2001, 
the percentages will be 25 percent charge-based and 75 percent 
resource-based. For subsequent years, the RVUs will be totally 
resource-based.
    Section 4505(e) of BBA provided that, for 1998, the practice 
expense RVUs be adjusted for certain services in anticipation of the 
implementation of resource-based practice expenses beginning in 1999. 
Practice expense RVUs for office visits were increased.
    For other services whose practice expense RVUs (determined for 
1998) exceeded 110 percent of the work RVUs and were provided less than 
75 percent of the time in an office setting, the 1998 practice expense 
RVUs were reduced to a number equal to 110 percent of the work RVUs. 
This limitation did not apply to services that had a proposed resource-
based practice expense RVU in the June 5, 1998 proposed rule that was 
an increase from its 1997 practice expense RVU.
    The total of the reductions under this provision was less than the 
statutory maximum of $390 million. The procedure codes affected and the 
final RVUs for 1998 were published in the October 31, 1997 final rule 
(62 FR 59103).
    Section 4505(d)(2) of BBA required that the Secretary transmit a 
report to the Congress by March 1, 1998, including a presentation of 
data to be used in developing the practice expense RVUs and an 
explanation of the methodology. A report was submitted to the Congress 
in early March 1998. Section 4505(d)(3) required that a proposed rule 
be published by May 1, 1998, with a 90-day comment period. For the 
transition to begin on January 1, 1999, a final rule must be published 
by October 30, 1998.
    BBA also required that we develop new resource-based practice 
expense RVUs. In developing these new practice expense RVUs, section 
4505(d)(1) required us to--
    <bullet> Utilize, to the maximum extent practicable, generally 
accepted accounting principles that recognize all staff, equipment, 
supplies, and expenses, not just those that can be tied to specific 
procedures, and use actual data on equipment utilization and other key 
assumptions;
    <bullet> Consult with organizations representing physicians 
regarding the methodology and data to be used; and
    <bullet> Develop a refinement process to be used during each of the 
four years of the transition period.
2. Proposed Methodology for Computing Practice Expense Relative Value 
Units
(See Addendum B in the June 5, 1998 proposed rule (63 FR 30888) for a 
detailed technical description of the proposed methodology.)
    In the June 5, 1998 proposed rule (63 FR 30827), we proposed a 
methodology

[[Page 58817]]

for computing resource-based practice expense RVUs that uses the two 
significant sources of actual practice expense data we have available: 
the Clinical Practice Expert Panel (CPEP) data and the American Medical 
Association's (AMA's) Socioeconomic Monitoring System (SMS) data. This 
methodology is based on an assumption that current aggregate specialty 
practice costs are a reasonable way to establish initial estimates of 
relative resource costs of physicians' services across specialties. It 
then allocates these aggregate specialty practice costs to specific 
procedures and, thus, can be seen as a ``top-down'' approach.

Practice Expense Cost Pools

    We used actual practice expense data by specialty, derived from the 
1995 through 1997 SMS survey data, to create six cost pools: 
administrative labor, clinical labor, medical supplies, medical 
equipment, office supplies, and all other expenses. There were three 
steps in the creation of the cost pools.
    Step 1: We used the AMA's SMS survey of actual cost data to 
determine practice expenses per hour by cost category. The practice 
expenses per hour for each physician respondent's practice was 
calculated as the practice expenses for the practice divided by the 
total number of hours spent in patient care activities by the 
physicians in the practice. The practice expenses per hour for the 
specialty are an average of the practice expenses per hour for the 
respondent physicians in that specialty.
    Step 2: We determined the total number of physician hours, by 
specialty, spent treating Medicare patients. This was calculated from 
physician time data for each procedure code and the Medicare claims 
data. The primary sources for the physician time data were surveys 
submitted to the AMA's Specialty Society Relative Value Update 
Committee (RUC) and surveys done by Harvard for the initial 
establishment of the work RVUs.
    Step 3: We then calculated the practice expense pools by specialty 
and by cost category by multiplying the practice expenses per hour for 
each category by the total physician hours.

Cost Allocation Methodology

    For each specialty, we separated the six practice expense pools 
into two groups and used a different allocation basis for each group.
    <bullet> For group one, which includes clinical labor, medical 
supplies, and medical equipment, we used the CPEP data as the 
allocation basis. The CPEP data for clinical labor, medical supplies, 
and medical equipment were used to allocate the clinical labor, medical 
supplies, and medical equipment cost pools, respectively.
    <bullet> For group two, which includes administrative labor, office 
expenses, and all other expenses, a combination of the group one cost 
allocations and the physician fee schedule work RVUs were used to 
allocate the cost pools.
    <bullet> For procedures performed by more than one specialty, the 
final procedure code allocation was a weighted average of allocations 
for the specialties that perform the procedure, with the weights being 
the frequency with which each specialty performs the procedure on 
Medicare patients.

Other Methodological Issues

Professional and Technical Component Services
    Using the methodology described above, the professional and 
technical components of the resource-based practice expense RVUs do not 
necessarily sum to the global resource-based practice expense RVUs 
since specialties with different practice expenses per hour provide the 
components of these services in different proportions. We made two 
adjustments to the methodology, depending on the specific HCFA Common 
Procedure Coding System (HCPCS) code, so that the professional and 
technical component practice expense RVUs for a service sum to the 
global practice expense RVUs.
Practice Expenses per Hour Adjustments and Specialty Crosswalks
    Since many specialties identified in our claims data did not 
correspond exactly to the specialties included in the practice expenses 
tables from the SMS survey data, it was necessary to crosswalk these 
specialties to the most appropriate SMS specialty category. (See Table 
3 in the June 5, 1998 proposed rule (63 FR 30833) for a listing of all 
proposed crosswalks.)
    We also made the following adjustments to the practice expense per 
hour data:
    <bullet> We set the medical materials and supplies practice 
expenses per hour for the specialties of ``Oncology'' and ``Allergy and 
Immunology'' equal to the medical materials and supplies practice 
expenses per hour for ``All Physicians,'' stating that we make separate 
payment for the drugs furnished by these specialties.
    <bullet> We based the administrative payroll, office, and other 
practice expenses per hour for the specialties of ``Physical Therapy'' 
and ``Occupational Therapy'' on data used to develop the salary 
equivalency guidelines for these specialties. We set the remaining 
practice expense per hour categories equal to the ``All Physicians'' 
practice expenses per hour from the SMS survey data.
    <bullet> Due to uncertainty concerning the appropriate crosswalk 
and time data for the nonphysician specialty ``Audiologist,'' we 
derived the resource-based practice expense RVUs for codes performed by 
audiologists from the practice expenses per hour of the other 
specialties that perform these codes.
    <bullet> Because we believed that the use of the average practice 
expenses per hour should create the appropriate practice expense pool 
for radiology, we did not attempt to differentiate the practice 
expenses per hour for radiologists according to who owned the 
equipment.
Time Associated With the Work Relative Value Units
    The time data resulting from the refinement of the work RVUs have 
been, on the average, 25 percent greater than the time data obtained by 
the Harvard study for the same services. We increased the Harvard time 
data in order to ensure consistency between these data sources.
    For services such as radiology, dialysis, and physical therapy, and 
for many procedures performed by independent physiological laboratories 
and the nonphysician specialties of clinical psychologist and 
psychologist (independent billing), we calculated estimated total 
physician times for these services based on work RVUs, maximum clinical 
staff time for each service as shown in the CPEP data, or the judgment 
of our clinical staff.
    We calculated the time for Current Procedural Terminology (CPT) 
codes 00100 through 01996 using the base and time units from the 
anesthesia fee schedule and the Medicare allowed claims data.
    We received the following comments on our proposed methodology to 
calculate resource-based practice expense RVUs:
Top-Down Methodology
    Comment: Most of the physician specialty societies commenting on 
our proposed general methodology supported the use of the top-down 
approach as the most reasonable methodology for developing resource-
based practice expense RVUs, and the most responsive approach to the 
requirements of BBA. This was echoed by comments from several 
nonphysician organizations, the Association of American Medical 
Colleges, and the Medical Group Management

[[Page 58818]]

Association, as well as several hundred individual commenters.
    These commenters supported the top-down method for a variety of 
reasons:
    <bullet> It reflects the relative values of physicians' actual 
practice expenses.
    <bullet> It uses the best available sources of aggregate practice 
expense data.
    <bullet> It recognizes specialty-specific indirect costs.
    <bullet> It does not rely upon arbitrary, distorting data 
adjustments such as ``linking'' and ``scaling.''
    <bullet> It is conducive to refinement.
    MedPAC also agreed that this approach is necessary, because of 
limitations in the CPEP process and because the top-down approach 
assures that all practice costs are reflected in the RVUs.
    However, several organizations, mainly representing primary care 
physicians and supported by comments from individual physicians, 
opposed the use of a top-down methodology to develop practice expense 
RVUs. They argued that the top-down approach is not resource-based but, 
rather, rewards higher paid physicians who have spent more in the past, 
regardless of the extent to which these expenditures contributed to 
patient care. Thus, the commenters claimed that the top-down approach 
perpetuates the inequities in the current charge-based practice expense 
RVUs that the implementation of a resource-based practice expense 
system was supposed to correct.
    One commenter also claimed that the top-down approach is not 
responsive to the requirements of BBA, as the methodology is not based 
on generally accepted accounting principles. Further, the commenter 
argued that this new proposal is not more responsive to the concerns of 
the medical community in general but, rather, only benefits those 
specialties whose income was projected to decline under the bottom-up 
approach.
    A specialty society representing clinical oncology opposed the top-
down methodology because--
    <bullet> It does not actually measure appropriate input resource 
costs and thus pays for inefficiencies;
    <bullet> It overpays hospital-based and underpays office-based 
services; and
    <bullet> The RVUs for individual codes cannot be refined because of 
the use of macro-specialty per hour costs.
    There were several comments that expressed concern about the more 
specific impacts of the methodology. A major primary care organization 
pointed out that, under the 1997 proposed rule, an internist would have 
had to provide only 15 midlevel established patient office visits to 
obtain the practice expense reimbursement of a single coronary triple-
bypass graft, compared to 40 visits under our current proposal. One 
organization opposed the use of the top-down approach because of the 
estimated reduction in payments to radiology and radiation oncology. 
Another commenter, representing pathologists, expressed concern that 
because pathology received small gains under the bottom-up method, but 
a 10 percent reduction under the top-down, there are possible flaws in 
the top-down methodology.
    A few of the above comments specifically recommended that we adopt 
a new bottom-up approach that is responsive to the BBA, the General 
Accounting Office (GAO), and the concerns of the medical community. 
Another organization commented that both top-down and bottom-up 
methodologies are inherently flawed, and that we should consider an 
entirely new payment algorithm using type of practice. One of the major 
primary care organizations concluded that the top-down methodology is 
only a reasonable starting point that will need to be improved during 
refinement in order to meet the original intent of improving practice-
expense payments for undervalued primary care and other office-based 
services.
    Response: As we stated in our proposed rule, BBA requires us to 
``utilize, to the maximum extent practicable, generally accepted cost 
accounting principles which recognize all staff, equipment, supplies, 
and expenses, not just those which can be tied to specific 
procedures****'' We still believe that the top-down methodology is more 
responsive to this BBA requirement. By using aggregate specialty 
practice costs as the basis for establishing the practice expense 
pools, the top-down method recognizes all of a specialty's costs, not 
just those linked to specific procedures.
    We also believe that the other reasons outlined in the proposed 
rule for preferring the top-down method are still valid. It answers 
many of the criticisms and questions from the medical community and the 
GAO regarding the bottom-up method's indirect practice expense 
allocation method, treatment of administrative costs, and use of caps 
and linking.
    However, we agree that a possible weakness of the top-down approach 
is that it may perpetuate historical inequities in the current charge-
based practice expense RVUs. More highly paid physicians would 
presumably have more revenues that could subsequently be spent on their 
practices. We believe this issue should be discussed during the 
refinement process.
    Comment: One major organization commented that we will need to 
develop an alternative method for new and revised codes that are not 
included in the SMS data because having multiple methods would lead to 
questionable validity.
    Response: It will not be necessary to develop an alternate 
methodology for refinement of new and revised codes. Once direct inputs 
are assigned to the new and revised codes, allocation to these codes 
will follow the same methodology used for all other services. (See 
Section II.A.4, Refinement of Practice Expense RVUs.)
    Comment: Two major primary care organizations expressed concern 
that we did not consult with the physician community about our 
intention to abandon, rather than refine, our originally proposed 
bottom-up approach, since they had assumed we would only be modifying 
our original methodology. They commented that this is of greater 
concern in light of BBA's requirement that we consult with physicians 
regarding our methodology and of GAO's recommendation that we refine, 
with no mention of replacing, the bottom-up method. One of the comments 
stated, that as the GAO found the bottom-up method acceptable, their 
society would like the GAO's assurance that the new method is sound.
    Response: We believe we carried out the BBA requirement to consult 
with physician organizations. There were extensive consultations with 
physicians, including the validation panels, the cross specialty panel, 
and the indirect cost symposium. During the course of each of these 
meetings, physicians and others pointed out serious problems with the 
bottom-up methodology. We have had two multispecialty meetings this 
year to explain our proposed methodology and have also had numerous 
meetings and discussions with many specialty societies. During all 
these meetings we carefully listened to all points of view and to 
suggestions for developing the new proposal. Following this lengthy 
consultation process, we published our new proposal with a 90-day 
comment period. This provided further opportunities for all interested 
groups to review and comment on this proposal.
    It is true that the GAO did not recommend that we totally replace 
our bottom-up approach. It is our understanding that the GAO was not 
asked to review alternative methods. In any case, their report did not 
recommend against adopting a new methodology. Their report did point 
out

[[Page 58819]]

several significant weaknesses in our original approach that we 
believed were better responded to by adopting a top-down methodology.
    Comment: One organization urged that we publish the practice-
expense RVUs three ways, using a top-down, a bottom-up, and a hybrid 
approach that uses SMS data for indirect costs and CPEP data for direct 
costs. The bottom-up and hybrid approaches should reflect the 
recommendations previously received relating to scaling, linking, and 
the treatment of administrative costs. This could provide a basis for 
developing comments that compare the interim practice expense RVUs with 
those derived from a modified bottom-up approach. The commenter stated 
that we should be open to considering arguments for a change in the 
interim practice expense RVUs based on a group's determination that the 
values under the bottom-up approach were more accurate.
    Response: We believe that we proposed the methodology for 
developing resource-based practice expense RVUs that best responds to 
the requirements of the Social Security Act Amendments of 1994 and BBA. 
From a practical standpoint, it would be very difficult to deal with 
the inconsistencies between RVUs for various services that have been 
derived from totally different methodologies.

SMS Data

    Comment: Almost all specialty society commenters, and many 
individual commenters, raised questions concerning shortcomings in the 
SMS data, though several commented that SMS is the most appropriate 
data source to use in developing specialty-specific practice expense 
RVUs. As we noted in the proposed rule, the AMA itself pointed out that 
the survey had not been designed to support the development of practice 
expense RVUs. The AMA also stated that the sample size, the response 
rate, and the fact that data was collected on the physician level, 
rather than the practice level, raised methodological issues. Many 
commenters echoed these concerns, and many raised what they saw as 
further general methodological problems:
    <bullet> MedPAC expressed concern about three types of potential 
errors in the SMS data: the sampling error and nonresponse error 
originally identified in our proposed rule and measurement error. Some 
of this measurement error could occur because the survey measures 
physician-level rather than practice-level costs, as noted above. In 
addition, there could be measurement error by using a self-reported 
survey if no mechanism exists to verify the information provided.
    MedPAC suggested that we could reduce these errors through 
additional data collection, perhaps implementing a subsample of SMS 
survey participants, through an analysis of nonresponse error that 
compares respondents with nonrespondents, through AMA's plans to do a 
practice-level survey every other year, and through considering 
methods, other than actual audits, to verify survey responses.
    <bullet> Several of the smaller specialties, such as maxillofacial, 
pediatric, vascular and thoracic surgeons, cardiology and gynecology 
subspecialties, geriatricians, and pulmonologists expressed concern 
with the validity and reliability of SMS data for those specialty and 
subspecialty groups not adequately represented in the SMS survey. A 
commenter also stated that academic and hospital-based specialties, 
such as critical care and neonatology, were not appropriately 
represented. Many specialty societies requested that we consider 
practice expense data obtained by under-represented specialty and 
subspecialty groups.
    <bullet> Several nonphysician specialties, though supporting the 
use of SMS data, raised the need to modify the survey to include 
nonphysicians in the future. A commenter stated that, because 
nonphysicians were not represented in the SMS survey, we have been 
forced to make an educated guess about which specialties they most 
resemble. Another commenter pointed out that the SMS data contains no 
information about osteopathic physicians.
    <bullet> Several specialties, regardless of their overall sample 
size, expressed concerns about the combining together of subspecialties 
with differing practice costs. For example, organizations representing 
cardiologists commented that it is not known how many in their sample 
were providing evaluation and management services, as opposed to 
performing equipment intensive procedures that have much higher costs. 
Two specialty societies representing nuclear physicians, along with 
several hundred individual commenters, objected to the small sample of 
this subspecialty, with its high costs related to the use of 
radiopharmaceuticals, being combined with radiologists into a single 
practice expense pool. The comments recommended that we increase 
nuclear medicine's practice expense RVUs by 20 percent.
    Similarly, a vascular surgery organization objected to being 
combined with cardiothoracic surgeons, who made up 75 percent of the 
sample and whose practice style differs substantially from vascular 
surgeons. An organization representing pediatrics expressed concern 
that pediatric subspecialties were grouped together with their adult 
counterparts, such as gastroenterology. The AMA commented on this point 
that it plans refinements for future surveys to enhance the utility of 
the data.
    <bullet> Several commenters noted that the survey consisted of 
physician-owned practices, despite the trend toward more physicians 
working as employees, resulting in a possible bias toward solo or small 
group practices. For example, one commenter stated that the majority of 
emergency room physicians now work as employees or under contract. 
Another commenter asserted that the majority of pediatricians list 
their status as ``employed.'' The AMA commented, in this regard, that a 
key refinement to the SMS survey will be the development of a practice-
level survey to complement the current process.
    <bullet> One commenter questioned our assumption that physician 
respondents to SMS share practice expenses equally with all other 
physician owners in the practice, since there is no data to show that 
this is the prevalent method.
    <bullet> An organization representing nurses commented that issues 
related to changes in acuity and case mix in ambulatory care are not 
being addressed, particularly as they pertain to the increased 
professionalization of clinical staff types. The organization argued 
that there is a need to incorporate into the survey process a clearer 
distinction between the types of clinical staff that are employed based 
on specialty practice.
    <bullet> Concerns were raised by some commenters that the SMS data 
did not always include the actual costs of a given specialty. Several 
organizations representing radiologists, radiation oncologists, and 
cardiologists commented that the methodology employed by the SMS survey 
consistently underestimated the actual costs of equipment. 
Organizations representing emergency room physicians, supported by the 
comment from the AMA, argued that the significant costs of both stand-
by time and uncompensated care are not reflected in the SMS data and 
that these costs need to be recognized.
    A gastroenterology specialty society asserted that the SMS data 
grossly understated actual expenses when compared to its own study. Two 
commenters stated that costs for home visits, such as travel expenses 
and insurance, are not adequately represented in the data. One 
organization commented that the SMS

[[Page 58820]]

data fails to adequately incorporate resources, including billing, 
nursing time, and transportation costs for audiologists utilized in 
settings such as skilled nursing facilities.
    One commenter stated that the added costs for compliance with 
federal initiatives, such as anti-fraud and abuse efforts and the new 
evaluation and management documentation guidelines, are not yet 
reflected in the SMS data. These costs should be recognized during the 
refinement process and included in future surveys.
    <bullet> On the other hand, several commenters argued that costs 
were included in the SMS data that should be excluded because they are 
paid for separately from the physician fee schedule. One commenter 
pointed to separately reimbursable supplies and drugs, and another to 
the costs of taking physician staff into the hospital, as examples of 
costs included in SMS that could lead to a double payment by Medicare. 
A society representing vascular surgeons commented that the technical 
component of noninvasive vascular laboratory testing falls into this 
``gray zone.''
    <bullet> A national specialty society commented that the AMA 
analysis of the ``zero'' responses by specialty by cost categories 
(that is, those cost categories where respondents indicated there were 
no costs) shows that a significant percentage of pathologists' 
responses for direct cost categories are zero as compared to the 
``zero'' response rates for all physicians. The comment requested that 
the SMS pathology data be cleared of all ``zero'' responses for all 
cost categories, not just for the total cost category, prior to the 
calculation of mean costs. For the purpose of calculating practice 
expense per hour for pathology, the society said, we should only use 
data from pathologists who incur a particular cost.
    <bullet> There were a number of comments concerning the SMS data on 
the specialty-specific physician patient care hours, which is one of 
the variables used to compute the practice expense per hour for each 
specialty:
    <bullet> Many specialty societies stated their concern that in the 
calculation of the specialty-specific practice expense per hour, 
specialties working the longest hours are disadvantaged. One commenter 
pointed out that practice expense is not uniformly distributed over the 
course of a given day; there are less costs when patient care takes 
place after, rather than during, office hours.
    Another commenter argued that our approach assumes that all of the 
patient care hours in the SMS survey are reflected in our claims data. 
However, the commenter stated, much time spent in patient care 
activities is not billable, such as the involvement of transplant 
surgeons in patient care after the initial assessments but prior to the 
actual transplants.
    One specialty society stated that hospital-based physicians' hours 
of work are probably overstated, as they will include total time spent 
in the facility and not just hours of providing patient services. One 
commenter questioned both the accuracy of the SMS data on hours worked 
per week, as well as our assumption that the level of practice expense 
incurred increases proportionally with the hours spent in patient care. 
An organization stated that physician reports of number of hours are 
less reliable than the reports of costs and are prone to overstatement. 
For these reasons, five specialty societies recommended using a 
standardized work week, usually a 40-hour week, for all specialties.
    <bullet> Many other specialty groups argued equally vehemently 
against any standardization of the patient care hours. One group 
commented that subjective adjustments to the SMS data, especially those 
which reallocate practice expenses among specialties, should be 
avoided. The comment added that suggestions that a standardized 40-hour 
work week be imposed on the data should be rejected because the 
proposal is driven by an arbitrary, subjective presumption that cross-
specialty practice expense variations are ``too large.''
    Another group argued that, as many physicians work more than a 40-
hour week, such an adjustment would introduce additional error into the 
data and distort the relationship between different specialties' 
practice expenses per hour.
    <bullet> Three organizations were concerned about the advantage 
given to specialties that use nonphysician practitioners who are not 
reimbursable. In such cases, the physician would incur practice expense 
costs, but the time of practitioners would not be included in the 
physician patient care hours in the denominator of the practice expense 
per hour calculation.
    On the other hand, another commenter stated that we should not 
adjust the SMS data for midlevel practitioners, such as optometrists or 
audiologists, as physician practices employing midlevel practitioners 
are likely to be more complex than a physician-only operation.
    <bullet> One specialty society commented that the demographics of 
the SMS survey are not clear, as there are no assurances that the 
sample is not biased towards one particular area of the country and 
does not exclude some areas.
    Response: We believe that most of the above comments identified 
important areas for needed future improvement in our data collection 
efforts on aggregate specialty-specific practice expense. However, 
although the SMS survey was not initially intended to be used to 
develop practice expense RVUs, we believe it is the best available 
source of data on actual multispecialty practice costs that allows us 
to recognize all staff, equipment, supplies, and expenses, not just 
those that can be tied to specific procedures. Many specialties 
supported this.
    For example, a specialty society commented, ``As with any complex 
database, the AMA SMS database is not perfect. It is, however, the best 
available source of data for aggregate practice expenses.'' The Medical 
Group Management Association (MGMA) stated in its comment that, ``The 
SMS survey data is the most appropriate and only primary data set in 
existence to determine specialty specific costs pools.''
    We also need to point out that many of the weaknesses in the SMS 
data could well be found in any other survey, whether undertaken by us, 
some other national group, or a medical specialty society. Problems 
with sample size and response rate have plagued other previous attempts 
to gather reliable data on practice expenses. Problems with measurement 
error may be a serious impediment for survey data that is collected 
with the purpose of influencing the level of a given specialty's 
practice expense pool. In fact, we believe one advantage of the current 
SMS data is that they were collected before the 1997 and 1998 proposed 
rules were published.
    We recognize that some specialties are under-represented or not 
appropriately represented in the SMS data and some are not included at 
all. We also acknowledge that additional data may need to be obtained 
and some adjustments made. One of our most important tasks during the 
immediate refinement period will be to work with the AMA and the 
medical community to consider possible ways to improve the 
representativeness of the aggregate specialty-specific data so that 
sampling error is decreased. As part of the refinement, we will also 
need to develop strategies to eliminate as many sources of nonresponse 
and measurement error as possible. (For further information on our 
refinement efforts to improve the accuracy of our

[[Page 58821]]

data, see Section II.A.4, Refinement of Practice Expense RVUs.)
    As indicated earlier, we believe an advantage of the SMS data we 
used is that it was collected prior to the proposed rule. In fact, it 
was collected prior to the original proposal in 1997 that was delayed 
by BBA and that would have resulted in large redistributions among 
specialties.
    We are very concerned, though, about the potential biases that may 
exist in any subsequent survey data collected by the SMS process or 
other surveys. We especially believe there is a problem in using data 
collected and submitted to us by individual specialties. We believe it 
is more appropriate to use data collected at the same time by an 
independent surveyor for a wide variety of specialties that both gain 
and lose under the proposal.
    Further, now that it is widely known how these survey data are 
being used, every specialty has an incentive to ensure that their data 
are as high as possible in future surveys. We agree with MedPAC that it 
may not be possible for Medicare to audit these data and that it is 
essential that alternatives be established by SMS and others. Perhaps 
specialty data that significantly changes in a future survey should be 
selectively audited by SMS through an independent auditor or other 
appropriate entity before being considered for use by us. We will 
consult with physician groups and others about this during the 
refinement process.
    Comment: One national organization suggested the use of MGMA survey 
data either as a supplement or alternative to SMS in the future.
    Response: We do not believe that the MGMA survey could currently be 
used as an alternative to SMS. As we noted in our proposed rule, due to 
selective sampling and low response rate, this survey is not 
representative of the population of physicians and cannot be used to 
derive code-specific RVUs. This view is based on consultations with 
MGMA representatives. However, we do believe that this survey data can 
be used as one way to validate the general accuracy of the SMS data. We 
have analyzed the MGMA data and have concluded that, in general, it 
supports the relative specialty-specific ranking of the practice 
expense per hour data derived from the SMS survey.
    Comment: One specialty society recommended using median, instead of 
mean, values to calculate each specialty's practice expense per hour. 
This comment argued that the use of medians would eliminate outliers 
and is statistically more appropriate.
    However, three other organizations specifically commented 
supporting our decision to use mean SMS data rather than median data. 
These comments asserted that, particularly with a small sample, use of 
the median would obscure any major differences in practice costs within 
a specialty.
    Response: We will continue to calculate the practice expenses per 
hour by using the mean values for each specialty, at least for the 
purposes of this final rule. This is another issue that can be 
revisited during the refinement period.
    Comment: Organizations representing emergency room physicians, as 
well as several hundred individual commenters, claimed that the SMS 
data seriously under-represented the true practice costs of emergency 
care. The commenters stated that the SMS data, as noted above, did not 
include costs of uncompensated care, much of it mandated under the 
Federal Emergency Medical Treatment and Active Labor Act (Public Law 
99-272), nor stand-by expenses.
    In addition, the comments argued, the SMS data failed to capture a 
representative cross-section of their types of practice arrangements; 
the SMS survey focused on physician owners, but the majority of 
emergency room physicians work as employees or under contract. 
Therefore, one commenter asserted, SMS did not include the largest 
single expense for most emergency physicians: the costs associated with 
employment by practice management firms, which can total between 30-40 
percent of the physician's fee.
    One of the specialty societies included with its comments the 
results of a study it commissioned, which showed that the mean practice 
expense per hour for emergency physicians was $27.33, more than double 
the $13 per hour based on SMS, even without including uncompensated 
care. If we are not willing at this time to substitute this survey data 
for that from the SMS, the organization recommended, with support from 
a comment from the AMA, that we crosswalk emergency medicine to the 
practice expense per hour for ``All Physicians,'' which is $67.50.
    Response: Though many specialties must deal with the issue of 
uncompensated care, we do agree that it may pose a particular problem 
for emergency physicians, who are obligated under law to treat any 
patient regardless of the patient's ability or willingness to pay for 
treatment. Therefore, the amount of patient care hours spent on 
uncompensated care could be significantly higher for emergency medicine 
than for any other specialty. These issues require further examination. 
In the meantime, we will make an adjustment in our calculation of the 
practice expense per hour for emergency medicine by using the ``All 
Physicians'' practice expense per hour to calculate the administrative 
labor and other expenses cost pool. We will continue to calculate the 
clinical labor, supply, equipment, and office cost pools using the SMS-
derived data, as it seems unlikely that, as a hospital-based specialty, 
emergency medicine's costs for these categories would approximate those 
of the average physician.
    Comment: Many commenters argued that the reductions published in 
the June 5, 1998, NPRM for services without work RVUs were 
inappropriate. The commenters represented a wide spectrum of 
specialties including radiology, radiation oncology, cardiology, 
independent physiological and other laboratories, psychology, 
audiology, dermatology, and others. These comments focused on the fact 
that AMA does not survey some of the entities that provide these 
services. They argued that the CPEP data are flawed and the indirect 
allocation methodology is biased.
    Response: Although it is true that the AMA does not survey the 
entities that provide some of these services, this does not necessarily 
mean that these services are inadequately represented in the SMS data. 
If these services (or in the case of technical component services, the 
associated global services) are provided in the practices of physician 
owners surveyed by the SMS in the same proportion as they are reflected 
in our claims data, the practice expense per hour calculations and the 
practice expense pools are reasonable.
    If the CPEP data accurately contain the direct cost inputs for 
these services, then the direct practice expense pool is being 
allocated appropriately. With regard to the indirect allocation 
methodology, we are modifying it to increase the weight of the direct 
costs in the allocation, as discussed elsewhere.
    However, the possibility exists that inaccuracies in the CPEP data 
for these services are causing the substantial reductions seen in the 
NPRM. Therefore, because we are not altering the CPEP at this time, as 
an interim solution until the CPEP data for these services have been 
validated, we have created a practice expense pool for all services 
without work RVUs regardless of the specialty that provides them. We 
allocated this practice expense pool to procedure codes using the 
current practice expense relative value units.

[[Page 58822]]

    While we are not convinced by the comments that were received to 
date regarding a bias in the SMS survey data against these services, we 
acknowledge those concerns and will examine this issue during the 
refinement process.
    Comment: The College of American Pathologists (CAP) requested that 
patient care time included in the SMS data that is spent in autopsies 
and supervision of technicians and paraprofessionals be excluded from 
the patient care hours used to calculate the practice expense per hour 
for pathology services. The commenter stated that these are Part A 
services for which pathologists rarely incur any direct costs. The AMA 
supported these adjustments and estimated the percentage of total 
pathology patient care hours attributable to autopsy and supervision 
services at 6 and 15 percent, respectively.
    CAP also asked that some portion of the patient care hours category 
of ``personally performing nonsurgical laboratory procedures including 
reports'' be eliminated for 1999 when determining pathologists' total 
patient care hours, as the SMS data includes both Part A and Part B 
services. CAP stated that we should work with the CAP and the AMA to 
determine the appropriate adjustment.
    Response: Since pathologists have more Part A reimbursement than 
any other specialty, we will decrease the number of patient care hours 
by 6 percent for autopsies and 15 percent for supervision services. 
However, until we have more information about the appropriate 
adjustment for ``personally performing non-surgical laboratory 
procedures including reports,'' the hours for those services cannot be 
eliminated from our calculations. This point, as well as the general 
issue of nonbillable hours, should be revisited during refinement.
    Comment: Many specialty societies have commented on specific 
problems with the SMS data that affect their own specialty and have 
requested that we supplement or replace the SMS data with data provided 
with their comments.
    Response: There is not sufficient time before publication of the 
final rule to begin to validate either the methodology or findings of 
the submitted data. Since changes in any specialty's practice expense 
per hour would have an impact on other specialties, we do not believe 
it would be equitable to make any sweeping changes without the adequate 
review that the refinement process can achieve. In addition, we stated 
in our proposed rule that, for those larger specialties included in the 
SMS survey, ``we are unlikely to make any changes in the final 
rule****'' Therefore, we will continue to use the SMS-derived practice 
expense per hour for these specialties, but will ensure that all of the 
submitted data will be considered during the refinement process.

CPEP Data

    Comment: Though one major specialty society commented that the CPEP 
data, in general, is relatively sound, many comments pointed out 
problems with the CPEP process and with the data derived from that 
process:
    <bullet> One group commented that the CPEPs did not have adequate 
representation from practice managers; that there was no uniform policy 
dealing with issues such as duplication of time or efficiencies that 
might result from performing more than one task at a time; and that 
there was inadequate time allotted for CPEPs to meet.
    <bullet> Several subspecialties pointed out that they were not 
included in the CPEP process and that this could have led to the 
undervaluing of their services.
    <bullet> Several commenters recommended that we use the CPEP data 
as validated and refined by the validation panels.
    <bullet> One organization commented that the CPEP data are flawed 
since only 200 codes were reviewed by validation panels.
    <bullet> One primary care group argued that we should not abandon 
edits and modifications to raw CPEP data, as many codes are performed 
by more than one specialty, and inaccuracies in the CPEP data can 
affect several specialties.
    <bullet> Two organizations commented that the CPEPs used what is 
now obsolete salary and benefits data, at least for sonographers and 
vascular technologists. One of these comments pointed out that for some 
codes, a different cost was computed for the same equipment. Another 
specialty society recommended that a review of prices and quantities 
for supplies and equipment be included as part of the refinement 
process.
    <bullet> Two commenters were concerned that the CPEP data include 
expenses that can be billed separately. A primary care specialty 
society argued that we should edit out all direct inputs for services 
to hospital patients. The comment mentioned that since these services 
are paid for outside of the practice expense RVUs, failure to exclude 
these inputs can distort relativity across categories of services such 
as surgical services and office visits.
    <bullet> One commenter clarified that the costs of therapy aides 
are a part of practice expense and should be reflected in the CPEP 
data, while the services of therapy assistants are included in the work 
RVUs.
    Response: We are aware that the raw CPEP data we have used in our 
proposed methodology need further review. We also share many of the 
concerns raised by those commenting on the issue. However, we believe 
that the CPEP resource estimates, which were developed by practitioners 
representing all the major specialties, are the best procedure level 
data available at this time.
    Under our top-down methodology, the CPEP inputs are used solely to 
allocate each specialty's practice expense pool to the procedures 
performed by that specialty. We have always believed that the relative 
input estimates within families of codes for each specialty's CPEP data 
were generally appropriate. In addition, the most contentious CPEP 
values were the varying estimates for the administrative staff times, 
and these values are not utilized in our top-down approach.
    We chose not to apply the edits, caps, or linking that had 
originally been proposed in our 1997 proposed rule as part of our 
bottom-up methodology. These edits had met with severe criticism from 
the medical community and were questioned by the GAO. We also did not 
use the revised inputs from the validation panels we held in October 
1997, as these panels only came to consensus on about 200 codes, and we 
were not convinced that all of the revised values were correct. 
However, we know that there is much needed improvement in the CPEP 
data, and the identification and correction of any CPEP errors whether 
in staff times, supplies, equipment, or pricing will be a major focus 
of our refinement process.
    Comment: One specialty society commented that we erred in not 
incorporating increases in staff time recommended by validation panels. 
Partly as a result, the practice expense RVUs for gastroenterologists' 
out-of-office billing, scheduling, and record keeping are inadequate.
    Another commenter stated that there were discrepancies in the 
administrative data for skilled nursing facility services, with 
subsequent visit codes being assigned only half of the billing time of 
initial visits. A third commenter requested that we standardize the 
administrative staff types according to the validation panels' 
recommendations. Three commenters stated that we do not account for the 
costs of maintaining an office full-time when the physician is 
providing services out of the office.

[[Page 58823]]

    Response: As stated above, under our proposed methodology, CPEP 
administrative staff times have no effect on the practice expense RVUs 
calculated for any code. The costs of maintaining an office while the 
physician is providing services in a facility should be captured in the 
SMS cost data and, thus, are a part of each specialty's practice 
expense pool. As these would be indirect costs, they would be included 
in the practice expense for each service by use of our allocation 
methodology, which utilizes both directs costs and the physician work 
RVUs.
    Comment: Almost 30 specialty societies submitted specific CPT code-
level changes for the CPEP input data for clinical and administrative 
labor time, supplies, and equipment for just under 3000 CPT codes. In 
addition, many commenters included lists of codes with practice expense 
RVUs that were considered anomalous, either within a code family, or in 
relation to comparable codes. We also received comments from several 
organizations with recommendations for revised crosswalks for those 
codes not valued by the CPEPs, as well as recommended in-office inputs 
for some codes that are now being done in the office, but were only 
given practice expense RVUs for the facility setting.
    Response: We had intended to make the CPEP revisions requested by a 
given specialty as part of the final rule if the recommendations 
appeared reasonable and if there would be no significant impact on any 
other specialty. However, given the huge volume of recommended 
revisions--over a third of the codes in the fee schedule would be 
affected--acceptance of the recommended changes across the board would 
almost certainly have a spill-over impact on many subspecialties and 
between sites-of-service.
    We believe it would be more responsible and fair to allow the 
medical specialties to participate collectively in the needed revisions 
as part of the refinement process. The deferral of the CPEP revisions 
is in no way a reflection on the effort and thought that the commenters 
obviously expended in arriving at their recommendations. All the code-
specific comments referred to above will be considered at the start of 
the refinement period. (See Section II.A.4, Refinement of Practice 
Expense RVUs)
    Comment: Many organizations, representing both surgical and primary 
care specialties, expressed concern that we averaged CPEP data for the 
same procedures valued by more than one CPEP. Different rationales were 
offered for this concern:
    <bullet> Averaging could have disturbed the relative rankings of 
codes within CPEPs.
    <bullet> Straight averaging significantly overstated the costs of 
evaluation and management services.
    <bullet> Averaging CPEP costs altered practice expense 
relationships within the evaluation and management family of services, 
particularly with respect to emergency department evaluation and 
management codes.
    <bullet> The inclusion of estimates from those not performing the 
procedures, including nonphysicians, could have distorted the values 
for those services.
    Likewise, different solutions were offered to answer the concerns:
    <bullet> One specialty society recommended that we link the CPEP 
data rather than relying on straight averages.
    <bullet> Two organizations recommended using frequency-weighted 
averages.
    <bullet> Five groups recommended that the CPEP costs for redundant 
codes be based on the inputs from the dominant specialty's CPEP panel.
    Response: As we are making no other changes in the CPEP data for 
this final rule, we will continue to use straight averaging for the 
redundant CPEP codes for the purposes of this final rule. This issue 
will be considered further during refinement.
    Comment: Two commenters requested the inclusion in practice expense 
of the procedure-related supplies which are brought into a skilled 
nursing facility (SNF). One of these commenters made the same request 
for home visits.
    Response: Home visits are to be paid using the non-facility RVUs. 
Therefore, any supplies that would be used are already included in the 
payment. As for the SNF setting, this is an issue for refinement. We 
would need more information about the supplies and why the SNF is not 
responsible for providing them.
    Comment: The American College of Surgeons sent a list of new 
crosswalked codes where CPEP data had inadvertently been duplicated in 
our database.
    Response: We thank the commenter for pointing out this discrepancy, 
and these duplications have been deleted.

Physician Time

    Comment: One major specialty society recommended that efforts be 
undertaken to move toward greater consistency in physician time data. 
The commenter was concerned that since these data are derived from 
eight different sources using different methodologies, our inflation of 
the Harvard time data raises even more concern about consistency.
    Three major organizations, two representing primary care and the 
other a surgical specialty, recommended that we use the unadjusted 
Harvard and RUC survey data. One reason given was the implication for 
the work RVUs of any proposed revisions to the time data. The RUC 
commented that, while the RUC physician time data may be greater than 
Harvard time data for the same codes, it may be incorrect to assume 
that all Harvard time data should be increased. The RUC and several 
other organizations requested that we provide a description of the 
methodology we used to make adjustments to the data in both the RUC and 
Harvard physician time databases so they can comment on the validity of 
the changes.
    Response: The physician time data used for the development of the 
practice expense pools are based on the Harvard resource-based RVUs 
study and RUC survey data that were developed as part of the refinement 
of the work RVUs. Both sets of data were based on physician surveys. 
However, the RUC data, gathered in the process of refining the work 
values of many CPT codes, are more current and, on average, exceeded 
the original Harvard values by 25 percent. As a matter of consistency 
and fairness to those services not yet refined by the RUC, we increased 
the Harvard time data in proportion to the increases for related 
services. A detailed description of the methodology we employed to make 
all adjustments in physician time will be placed on the HCFA Homepage.
    We still believe this adjustment is appropriate and we will 
continue to use the adjusted values in our calculations for this final 
rule. However, as the time values attributed to each procedure play an 
important role in the determination of each specialty's practice 
expense pool, we believe that ensuring the increased accuracy and 
consistency of physician time data should be addressed as part of the 
refinement of the practice expense RVUs.
    Comment: Three surgical specialty societies commented that 
evaluation and management times have been artificially inflated due to 
rounding. A small increase in time would disproportionately inflate 
high volume procedures that take little time.
    Response: In our proposed rule, we expressed concern that 
imprecision in the time estimates for any high volume services that 
have relatively little time associated with them may potentially bias 
the practice expense methodology in favor of the specialties that 
perform these services. We stated at that time that this issue should 
be examined as

[[Page 58824]]

part of the refinement of the resource-based practice expense RVUs.
    Comment: There were several other comments regarding the accuracy 
of the physician time data:
    <bullet> The RUC acknowledged that some of the RUC physician time 
data may not be absolutely precise.
    <bullet> One specialty society, as well as the AMA, pointed out 
that there are some problems with the accuracy of the physician time 
data for psychotherapy services. For example, the times assigned to 
psychotherapy codes that include evaluation and management services are 
equal to and, in some cases, less than the psychotherapy codes that do 
not include these services.
    <bullet> One commenter stated that the physician time data, as 
computed in the Harvard studies, are not current and are likely to be 
inappropriate for use in computing practice expense RVUs.
    <bullet> The American College of Surgeons commented that physician 
time for pediatric surgery codes is based on erroneously low physician 
time data from the original Harvard study, rather than the time data 
from the special study of pediatric services performed by the same 
Harvard study team for the American Pediatric Surgical Association in 
1992. The latter data were used as the basis for the work RVUs assigned 
to 48 pediatric surgical services.
    <bullet> A surgical specialty society commented that the physician 
time does not compensate its members for longer hours and cited 
examples of nonbillable time, such as standby time for cardiac 
catheterization and supervision of residents and interns. The society 
suggested that this be considered during refinement.
    <bullet> One commenter stated that travel time for home visits is 
not included in either the work or practice expense RVUs. The commenter 
suggested that travel time for house calls should be equal to the work 
equivalent of the lowest office service times 3, for an average of 15 
minutes. Further, a modifier should be used to cover instances where 
travel exceeds the average.
    <bullet> The American Society of Transplant Surgeons identified 
physician times for several services that it believes are inaccurate 
and recommended adjusted times for these services.
    Response: As stated above, we will ensure that all identified 
anomalies and inaccuracies in the physician time data are considered as 
part of the refinement process.
    Comment: The American College of Radiology commented that for our 
top-down approach we had used a level three office visit (99213) as a 
benchmark for estimating physician time for radiology codes. They 
suggested that it would be more appropriate to use the intravenous 
pyelography procedure (CPT 74400) instead of the office visit used in 
our methodology.
    Response: Although we agree that 99213 may be an inappropriate 
benchmark since it is not often performed by radiologists, we are not 
convinced that the average work per unit time of codes on the radiology 
fee schedule is equivalent to CPT 74400. Instead, we are using the 
weighted average work per unit time for CPT 71010 and 71020 as the 
benchmark. These two services represent over approximately one-third of 
the total allowed services in the radiology fee schedule, while CPT 
74400 represents less than two-tenths of one percent. We will work with 
the medical community to develop time estimates for radiology 
procedures that will make the imputation of time from the work 
estimates unnecessary.
    Comments: The American Occupational Therapy Association commented 
that the practice expense pool for occupational therapy codes was 
understated because the time values of 15 minutes that we arbitrarily 
assigned were too low. They included a list of time values we should 
use for each code.
    The American Hospital Association also objected to the reductions 
in times for outpatient rehabilitation codes and urged the use of the 
actual surveyed times for all procedure codes in the range 97001 
through 97770.
    Response: We believe that the time of 15 minutes we assigned to 
these codes is appropriate and does not lead to an underestimation of 
the practice expense pool for outpatient rehabilitation services. The 
outpatient rehabilitation codes in this range are timed codes and are 
billed in 15 minute increments. Also, we have been told by some 
physical therapy associations that at times, some of the 15 minute 
period time may be performed by therapy aides or assistants. (Note: We 
plan to review this issue during a future five-year review of work 
RVUs.) Finally, it is common for these timed codes to be billed in 
multiple units during one therapy session. Thus, any therapist's work 
prior to or after the visit is spread across more than one unit, rather 
than applied to each unit.

Crosswalk Issues

    Comment: The American Academy of Maxillofacial Prosthetics (AAMP) 
and the American College of Prosthodontists commented that crosswalking 
is not valid for maxillofacial prosthetic codes since this specialty 
does not correspond to any other medical specialty included in the SMS 
data and its practice expense values are much higher than other medical 
specialties in the SMS survey. AAMP submitted several studies from its 
own organization and from the American Dental Association, as well as 
two studies published in professional journals that report the results 
of polls of prosthodontic practitioners, including information on 
overhead expenses. The AAMP recommended that this data be used to 
calculate its practice expense per hour.
    Response: We agree that maxillofacial prosthetics does not 
correspond closely with any other medical specialty. It also is not a 
separately-identified specialty in either the SMS survey or the 
Medicare claims database.
    Though the AAMP submitted survey data compiled by both its own 
organization and the American Dental Association, the format, 
definitions, and methodology of these surveys were not consistent with 
those of the SMS survey. For example, the 1993 AAMP survey did not 
survey practice expense, but rather the ``percent overhead of gross 
collections for 1992.'' The American Dental Association surveys counted 
dentist shareholder and employee dentist income as practice expense in 
many tabulations.
    Because of these methodological differences from the SMS data, we 
are not able at this time to use the information in the submitted 
surveys to calculate a comparable practice expense per hour for 
maxillofacial prosthetics.
    For this final rule we will create a practice expense pool for the 
maxillofacial prosthetic codes (CPT 21076 through 21087) and crosswalk 
this pool to the practice expense per hour for ``All Physicians.'' We 
had imputed physician times for these services in our proposed rule. 
However, we are now using the physician times utilized in calculating 
the work RVUs for the same services. In addition, until the CPEP data 
for these codes can be validated, we will allocate the practice expense 
pool to the specific services using the current RVUs. We hope to work 
with the specialty society as part of the refinement process in order 
to develop a reliable method of deriving accurate practice expense RVUs 
for maxillofacial prosthetics.
    Comment: The American Optometric Association (AOA) disagreed with 
our crosswalk of optometry to the average practice expense per hour for 
``All Physicians,'' that results in a practice expense per hour of 
$67.50. The commenter stated that AOA understands that the crosswalk 
decision

[[Page 58825]]

was based, at least in part, on the 1997 survey conducted by AOA which 
had been provided to us. This survey has been conducted regularly since 
1990 and was included with the comment, along with a study commissioned 
by the AOA entitled ``Results of the First National Census of 
Optometrists.'' Using data from this survey and study, AOA computed an 
$89.53 practice expense per hour for optometry, significantly higher 
than the average for ``All Physicians.''
    Response: As in the above request, the data submitted by AOA are 
not easily comparable to the SMS data. For example, the AOA calculation 
used medians rather than means, and retirement and fringe benefits were 
not counted as median net income, but rather as practice expense. It is 
therefore not possible, without further information, consultation, and 
analysis, for us to calculate a practice expense per hour that would be 
comparable with that of other specialties. During the refinement period 
we will be working with specialties not represented in the SMS survey 
to identify the data needed to enable us to determine accurate practice 
expense RVUs for their services.
    Comment: Although generally supporting the crosswalk to General 
Internal Medicine, the American Chiropractic Association (ACA) 
submitted data from the 1997 survey results of ACA's biannual survey of 
the chiropractic profession. This survey shows considerably lower 
direct patient care hours than SMS shows for General Internists. 
Therefore, the ACA requested that we use its data to calculate the 
practice expense per hour for Doctors of Chiropractic, stating that we 
should accept specialty societies' data over SMS data if they were 
collected in a comparable manner.
    Response: The survey submitted by the commenter indicated that the 
patient care hours worked by chiropractors are significantly lower than 
those of general internists to whom chiropractors' practice expense per 
hour is crosswalked. However, the hours of direct patient care a week 
shown in the survey were defined more narrowly than in the SMS data. 
For example, the 29 hours of patient care a week calculated in the 
submitted survey did not include the hours spent for documentation, 
administration, and billing, activities that we have considered to be 
included in the direct patient care hours for other specialties. In 
addition, there are insufficient details in the survey for us to 
determine its comparability to the SMS data and we will maintain the 
crosswalk for chiropractors for this final rule. We do intend, however, 
to revisit this issue during the refinement process.
    Comment: The American Podiatric Medical Association, Inc. (APMA) 
objected to its crosswalk to general surgery because it believes that 
there is little similarity between the two specialties based on site-
of-service and types of services provided. General surgery services are 
typically performed in the facility setting, while the high volume 
podiatry services are almost entirely done in the office. In addition, 
the comment stated that podiatrists work fewer hours than general 
surgeons.
    The comment also included the results from APMA's 1996 and 1998 
surveys of podiatric practice, as well copies of the surveys 
themselves. According to the comment, these surveys show that the 
actual practice expense per hour for podiatry is $91.50 and APMA 
recommends that we use this data in place of our proposed crosswalk.
    The American Academy of Orthopaedic Surgeons also disagreed with 
the crosswalk for podiatry, but recommended that podiatry be 
crosswalked to orthopaedic surgery in the short run, as 70 percent of 
the codes billed by podiatrists are those that are shared with 
orthopaedic surgery.
    Response: Because of significant methodological differences between 
the submitted surveys and the SMS data (for example, only gross and net 
incomes are surveyed) we are not able at this time to calculate a 
practice expense per hour in total, let alone for each of the different 
cost pools.
    However, we are persuaded that the crosswalk to general surgery is 
not appropriate for the reasons cited in the comment, and we are 
changing the crosswalk to ``All Physicians.'' We will be working with 
all specialties not represented in the SMS data to ensure that we 
obtain comparable information to calculate their practice expenses per 
hour.
    Comment: The Joint Council of Allergy, Asthma, and Immunology 
stated that, in calculating the allergists' practice expense per hour, 
we reduced the supply category practice expense per hour to that of 
``All Physicians,'' because we believed that we made a separate payment 
for the drugs used. However, this is not true for immunotherapy drugs 
provided by allergists, as the cost of these drugs is included in the 
practice expense RVUs. Therefore an adjustment needs to be made.
    Response: The commenter is correct and the adjustment has been made 
to the medical supplies practice expense per hour.
    Comment: The American Society of Clinical Oncology commented that 
since the SMS supply cost data for chemotherapy codes included the 
costs of expensive chemotherapy drugs, which are paid for separately, 
we used the lower supply costs for ``All Physicians'' for their supply 
cost pool. The commenter argued that this fails to recognize that, in 
addition to the cost of the drugs, chemotherapy administration has 
extra supply costs in excess of that for ``All Physicians.'' Also, 
although chemotherapy drugs are generally among the costliest drugs, 
the cost of drugs was probably included in other specialties' supply 
costs as well, and all specialties should be treated in the same 
manner.
    The Association of Community Cancer Centers, the Society of 
Gynecologic Oncologists, and the American Society of Hematology also 
disagreed with our adjustment for drug costs, as did the AMA, which 
called our method of correcting for the double counting of drugs 
inequitable and imprecise. The American Society of Hematology 
recommended increasing the supply per hour costs to 125 percent of the 
``All Physicians'' level.
    Response: It is true that other specialties may have some drug 
costs included in their SMS supply cost data, but we believe that the 
total costs for chemotherapy drugs are far greater than are the drug 
costs included for any other specialty. Failure to make an adjustment 
for these high drug costs would lead to a gross distortion in the 
supply cost pool for oncology.
    We also are not convinced that the other supply costs for 
oncologists would necessarily exceed that of ``All Physicians,'' and we 
will continue to crosswalk oncology's supply costs to that category's 
practice expense per hour. We do agree that during refinement we need 
to consider development of a methodology for removing separately 
billable supplies and services from the SMS data so that the Medicare 
program avoids making duplicate payments. We also will work with the 
oncology specialty to ensure that their practice expense per hour for 
the supply category adequately reflects the actual costs of other 
oncology supplies.
    Comment: The American Association of Oral and Maxillofacial 
Surgeons objected to the crosswalk of oral surgery and maxillofacial 
surgery to the practice expense per hour of ``All Physicians.'' They 
recommended a crosswalk to either otolaryngology or plastic surgery, as 
most of the medical procedures billed

[[Page 58826]]

by oral and maxillofacial surgeons can be crosswalked to these two 
specialties. The commenter argued that because of their significantly 
higher practice expenses, oral and maxillofacial surgery should not be 
in the same practice expense pool as manipulative therapists and 
optometrists, as this dilutes the practice expenses for these surgical 
services. In addition, the 1996 Harvard Study grouped oral and 
maxillofacial surgery under otolaryngology and plastic surgery.
    Response: We do not currently have sufficient data to make such a 
change in our crosswalk. This is an issue that can be addressed during 
the refinement period.
    Comment: The American College of Cardiology and the American 
Society of Echocardiography disagreed with the crosswalk of Independent 
Physiologic Laboratories (IPLs) to ``All Physicians.'' The comment 
recommended that IPLs' practice expense per hour be crosswalked to 
cardiologists, as 60 percent of IPL billings are in the 93000 series 
and for the 13 highest volume IPL codes, cardiologists account for 40 
percent of claims. The Society of Vascular Technology/Society of 
Diagnostic Medical Sonographers also expressed concern that our 
crosswalk of IPLs did not adequately recognize their costs and 
recommended that we use the figure of $176 per hour based on the 
studies cited in the comment.
    Response: As discussed above, we will be creating a separate 
practice expense pool for all services without physician work, which 
will include those technical component services done by IPLs and by 
cardiologists.
    Comment: The Society of Gynecologic Oncologists requested that we 
consider using multiple crosswalks to determine practice expense per 
hour for specialties that provide interdisciplinary care. The comment 
stated that the true reflection of practice expense per hour for a 
gynecologic oncologist is a hybrid of the practice expense per hour for 
the specialties of obstetrics and gynecology and oncology.
    Response: It is not clear whether this is desirable or what data 
would be used to weight such a split between more than one specialty. 
Many physicians belong to more than one specialty or subspecialty. This 
is another issue that can be discussed during the refinement period.
    Comment: The American Geriatrics Society disagreed with our 
crosswalk of geriatrics to the General Internal Medicine practice 
expense per hour. The comment stated that geriatricians typically have 
higher costs than internists because of the need for more office space 
and more health care professionals on staff. Since many geriatricians 
are family physicians, geriatrics should be cross-walked to family 
practice.
    Response: We believe that geriatricians are typically more like 
internists than family practitioners, so for the final rule we will not 
change the crosswalk. However, we are open to receiving data that would 
demonstrate that a crosswalk to family practice would be more 
appropriate.
    However, we would note that geriatrics is a relatively small 
specialty and the services performed by them are frequently done by 
other specialties. Thus, changes in the practice expense per hour data 
for geriatricians would not likely have a significant impact on the 
RVUs for services they perform.
    Comment: One commenter made recommendations for revisions or 
additions to our proposed crosswalks for several nursing 
subspecialties. Another specialty society commented that under the 
physician fee schedule we have chosen to pay nonphysician practitioners 
a percentage of the physician reimbursement, and crosswalking to 
specialties with higher practice expense per hour rates than general 
internal medicine or general surgery is not logical or reasonable. 
Another organization also recommended that data from nurse 
practitioners and physician assistants be excluded from the practice 
expense pool calculations.
    Response: We will further consider appropriate crosswalks for 
nursing subspecialties during the refinement period.
    Comment: The American Hospital Association and the American 
Occupational Therapy Association recommended that we crosswalk all of 
the practice expense pools for outpatient rehabilitation services to 
the ``All Physicians'' practice expense category, rather than using the 
salary equivalency guidelines for the administrative, office, and other 
pool.
    Response: We believe that using the ``All Physicians'' practice 
expense per hour for the administrative, office, and other pool would 
considerably overstate the actual practice expense for occupational 
therapy. We have carefully examined outpatient therapy practice costs 
for the development of the salary equivalency guidelines, and believe 
that these better approximate the actual expenses for this cost pool. 
We will continue to use the salary equivalency guidelines to calculate 
this portion of the practice expense pool for occupational therapy for 
this final rule.
    Comment: The American Speech-Language Hearing Association commented 
that it is not appropriate to use the practice expense per hour data 
from physicians that perform audiology tests and it submitted a 1993 
survey, ``Audiology Services--Scale of Relative Work,'' as part of its 
comments.
    Response: As we stated above, we are creating a single practice 
expense pool for all services, such as audiology, that have no work 
RVUs. This practice expense pool, created by using the average clinical 
staff time per procedure from the CPEP data and the ``All Physicians'' 
practice expense per hour, raises practice expense RVUs for audiology 
services relative to those previously proposed. However, during the 
refinement process we will be considering all data submitted on any of 
these services, including the study submitted with the above comment.

Calculation of Practice Expense Pools--Other Issues

    Comment: Several organizations commented on potential problems with 
the Medicare claims data, which are used as one component of the 
specialty-specific practice expense pool calculation.
    <bullet> Many commenters were concerned about reliance on Medicare 
claims data to determine the size of each specialty's practice expense 
pool. The comments claimed that to the extent that the Medicare 
population is not representative of the general population, there is a 
bias against specialties whose patient population does not match 
Medicare's. Several organizations, representing the gamut of medical 
specialties, urged us to work during the refinement period with 
organizations for whom we have no, or inadequate, historical claims 
utilization information and to acquire nationally representative claims 
data that include Medicare, Medicaid, and private payer data.
    One of these commenters recommended that, if this is not feasible, 
we should conduct sensitivity analyses to explore the influence 
Medicare service utilization patterns may have on private payers. The 
specialty-specific utilization data are crucial for the final step of 
volume-weighted averaging that brings the individual specialty scales 
onto one scale, particularly when involving services performed very 
frequently by specialties that see relatively few Medicare patients.
    For example, the comment argued, to the extent that the cost 
estimates for evaluation and management (E&M) services provided by 
obstetricians and gynecologists and pediatricians differ

[[Page 58827]]

significantly from those of specialties that account for the bulk of 
E&M services provided to Medicare patients, the use of an all-payer 
claims database would probably yield different RVUs for E&M services.
    <bullet> Several surgical specialties urged that we clean the 
Medicare claims data to eliminate obvious errors, such as data showing 
a sometimes significant number of nonsurgeons or physician assistants 
performing complex surgeries that can only be performed by surgical 
specialties. This misreporting can decrease a specialty's practice 
expense pool and should either be reassigned or excluded during 
refinement.
    One of the commenters recommended that Medicare claims data be 
reviewed for the existence of a second listed surgical specialty 
identifier. In addition, physician assistants' claims should use the -
AS modifier, and calculations should use only the time that is assigned 
to the intraoperative period.
    <bullet> Three specialty organizations commented that many 
physicians' self-designated specialties are incorrectly classified in 
our claims data. For example, many cardiologists and geriatricians may 
bill as internists, which may affect the respective practice expense 
pools. Until these data become more accurate, one of the commenters 
recommended that the specialty practice expense pools be recalculated 
on an annual basis.
    <bullet> An organization representing transplant surgeons commented 
that, as transplant surgery is not a designated specialty in the 
Medicare claims database, many transplant surgeons designate themselves 
as general surgeons, who have the lowest practice expense per hour of 
any surgical specialty. The comment argued that this has led to a 
significant underestimation of the costs associated with transplant 
surgery.
    Response: We would be interested in receiving any reliable national 
utilization data on the procedure code level though, to date, we are 
not aware of the existence of such a data source. We plan during the 
refinement period to work with the medical community in order to 
pinpoint problems in the Medicare claims data, to develop strategies to 
improve their accuracy, and, if possible, to find reliable supplemental 
data for those specialties not appropriately represented in the 
Medicare database.
    Comment: One organization commented that the Medicare frequency 
numbers for occupational therapy codes will be understated because BBA 
requires that all outpatient therapy services be paid under the 
Medicare Physician Fee Schedule beginning January 1, 1999.
    Response: We disagree. We have not included estimates for 
frequencies of expected services of outpatient therapy services in 
computing the practice expense RVUs. BBA specified that we pay for 
these services using the physician fee schedule. BBA did not 
incorporate these services into the fee schedule.
    Comment: Many organizations representing radiation oncology, as 
well as numerous individual commenters, argued that we erroneously 
combined the SMS radiation oncology survey data with that of radiology. 
The commenters argued that these two specialties should be dealt with 
separately, as radiation oncology utilizes different codes and has 
considerably higher costs than radiology.
    Response: We had combined radiation oncology and radiology together 
into one practice expense pool because of the small sample of radiation 
oncologists in the SMS data. However, we now agree with the commenters 
that these are two different specialties with differing practice costs. 
Therefore, we have separated them into two separate practice expense 
cost pools in order to calculate the practice expense per hour for each 
of the specialties. For radiology, excluding radiation oncology, the 
total practice expense per hour is $55.90. This is comprised of $17.90 
for nonphysician payroll per hour ($9.70 for clerical payroll), $12.80 
for office expense, $4.50 for supply expenses, $7.70 for equipment 
expense, and $12.90 for other expenses. For radiation oncology, the 
total practice expense per hour is $68.30. This is comprised of $23.70 
for nonphysician payroll per hour ($9.20 for clerical payroll), $11.30 
for office expense, $6.20 for supplies expense, $11.00 for equipment 
expense, and $16.20 for other expenses.

Allocation of Practice Expense Pools to Codes

    Comment: Several organizations commented on our use of work RVUs as 
part of the allocation formula for indirect practice expense costs:
    <bullet> A primary care specialty group stated that we should not 
allocate the indirect practice expenses using the work RVUs, since 
there is no reason to believe that the costs of providing the service, 
such as the cost of utilities, would vary by the intensity, where the 
costs would vary by time. We should, therefore, use time rather than 
work in our indirect allocation.
    Another primary care organization commented that using work as one 
allocator for indirect expenses inappropriately gives surgical 
procedures with higher work RVUs substantially higher administrative 
costs for billing activities than is given to evaluation and management 
services. We should develop a standardized method to address 
administrative staff costs.
    <bullet> Five other organizations argued that allocating indirect 
costs based on a combination of direct costs and physician work RVUs is 
inappropriate and treats unfairly chemotherapy and radiation oncology 
services as well as other technical component services, since they 
typically are assigned no work RVUs. Various recommendations were made 
by these commenters to rectify what they see as discrimination against 
these technical component services:
    + Indirect costs should be based on direct costs.
    + Physician time or clinical staff time should be used instead of 
work.
    + We could allocate 50 percent of the indirect costs based on 
direct costs and 50 percent based on physician work or time.
    + As an alternative for chemotherapy services, work could be 
imputed by using the work to time ratio for other hematology or 
evaluation and management services.
    One commenter recommended that we vary the indirect cost allocation 
methodology in recognition of the practice patterns of particular 
specialties.
    <bullet> One accounting organization commented that the use of work 
REUS is arbitrary and argued for the use of total dollars actually 
spent to perform the procedures, not indirect splits, suggesting the 
use of Activity Based Costing as a preferable methodology.
    Response: In this final rule, we will use an allocation method for 
the final rule that is basically similar to our proposed allocation 
method. It is widely recognized by accountants and others that there is 
no single best method of allocating indirect expenses to individual 
services. If we used physician time as an allocator of indirect 
expenses, we would be using the same values, whose accuracy have 
already been questioned by some commenters, both to create the practice 
expense pools and to allocate these pools to individual services. If we 
used only direct costs, we would be giving full weight to CPEP values 
that have not yet been refined. We agree that the use of physician work 
as an allocator is not preferable in the long term. It likely provides 
maximum advantage to hospital-based services in which the

[[Page 58828]]

physician incurs relatively few direct costs.
    For this final rule, we are making a technical change to the 
allocation method for indirect costs by using direct costs and the work 
REUS scaled using the Medicare conversion factor instead of a factor 
calculated using the physician time data. Because of questions raised 
by commenters concerning the time data adjustments, we believe that it 
is more appropriate to convert the work REUS into dollars using the 
Medicare conversion factor (expressed in 1995 dollars, consistent with 
the AMA SMS survey data). This will give somewhat less weight to work 
while, at the same time, avoiding a major methodological change until 
it has been examined further. We intend to work with the medical 
community during refinement so that we ensure that our allocation 
methodology is both appropriate and equitable.
    Comment: Many major specialty societies, both primary care and 
surgical, commented that we should not apply a different methodology 
for allocating the practice expense pools to the radiology codes than 
we do to all other codes. One commenter argued that multiplying the 
current charge-based practice expense RVUs for radiology codes by some 
percentage cannot yield a resource-based system.
    Organizations representing urologists, pulmonologists, 
cardiologists, and ophthalmologists commented that the uniform 
reductions made in the radiology codes to maintain relative values 
assumed that all radiology services are done only by radiologists, when 
many of these procedures are performed by these other specialties. A 
commenter stated that decisions regarding the practice expense values 
for radiology codes done predominantly by other specialists should not 
be made by one specialty. These organizations recommended that the 
practice expense RVUs for their codes be established using the 
allocation methodology used for all other services.
    One specialty society, representing diagnostic vascular testing, 
commented that the use of the existing radiology relatives to allocate 
practice expense to the code level results in significantly larger 
decreases in the technical component than in the professional component 
of their services. The commenter recommended that if we continue to use 
the radiology relatives, then we should reduce the professional 
components of the codes more than the technical components because 
practice expenses are greater for the technical component than for the 
professional component.
    The AMA supported the use of the radiology relative values for 
actual radiology services, but recommended that this methodology should 
be applied only to services that are performed predominantly by 
radiologists.
    The American College of Radiology endorsed the radiology relativity 
of the radiology RVUs without exception, and they would oppose the 
exclusion of individual radiology procedures since this is inconsistent 
with the concept of radiology relative values. They argued that 
maintaining the relativity of the radiology fee schedule--
    <bullet> Is consistent with generally accepted accounting 
principles because it is based on surveys and physician panels;
    <bullet> Is widely accepted;
    <bullet> Solves rank order anomalies caused by raw CPEP data;
    <bullet> Simplifies the derivation of the professional component, 
technical component, and global practice expense RVUs;
    <bullet> Is mandated by law, as the Omnibus Budget Reconciliation 
Act of 1989 stated that for radiology services ``the Secretary shall 
base the relative values on the relative values developed under section 
1395m(b)(1)(A)****''; and
    <bullet> They also argue that we have recognized and honored the 
statutory obligation to maintain the relationships in the radiology 
relative value scale.
    Another national organization representing diagnostic imaging 
services also suggested keeping the radiology fee schedule as the 
allocator for radiology, rather than the direct costs from the CPEP 
data, as there would be even greater reductions on codes we allocated 
using the CPEP relatives.
    Response: Because the majority of specialties that perform 
radiology services object to the use of the current practice expense 
RVUs for radiology services, we cannot continue to use these RVUs. 
However, since we are not making changes to the CPEP data for this 
final rule and since the American College of Radiology has not had 
sufficient opportunity to comment on the CPEP data because of our 
proposed use of the current radiology RVUs, we are using the current 
radiology RVUs to allocate the direct cost pools of the specialty 
radiology until such time as the CPEP data for radiology services have 
been validated. We will not use the current radiology RVUs for any 
other specialty.
    It should be noted that radiology services or components of 
radiology services that lack work RVUs are handled as described in the 
section on services without work RVUs. This alters the impact of using 
the current radiology RVUs for the specialty radiology since we set the 
global portion of a radiology service equal to the sum of the technical 
and professional components.
    Comment: One specialty society commented that, for one important 
high volume pathology service, the proposed total professional 
component practice expense RVU payment would be $11.37, approximately 
$2 short of the administrative labor costs alone. The commenter wanted 
more information on how our method splits administrative costs between 
the professional and technical components. The commenter requested that 
we provide a data set of the RVUs for administrative labor, office 
expenses, and other expenses that result from our allocation method, 
with a break-out of the professional and technical component RVUs for 
services that have both components, so that the appropriateness of the 
allocation method can be evaluated.
    Response: Our methodology was described in the proposal, and we 
also provided additional detailed data files that we used to develop 
the proposed values. We will try to make additional data available if 
the request is further specified.
    Comment: The American College of Cardiology expressed concern that, 
though it might be necessary to weight average the allocation to codes 
according to the practice expense per hour of the different specialties 
performing the service, this defeats the intent of Congress to 
recognize actual costs and could also lead to negative incentives. The 
commenter suggested that this is an issue that we and the specialties 
should pursue.
    The American Society of Echocardiography more specifically 
commented that we should not include in the calculations for 
cardiovascular diagnostic tests the even more unrepresentative data for 
internists coding for these procedures. The society maintained that 
because of the low equipment costs for internists, this blend dilutes 
the RVUs allocated to these codes.
    Response: The statute is very specific that Medicare is not to pay 
specialty differentials. Therefore, weight averaging of the CPEP inputs 
among specialties that do a service seems appropriate.

Other Issues

    Comment: Many commenters, representing a broad spectrum of 
specialties, expressed concern that reductions in payment for specific 
services could have a negative impact on access to care. Many of these

[[Page 58829]]

commenters recommended that we monitor access and quality of care 
issues that may arise as a result of the implementation of a resource-
based practice expense system.
    Response: Maintaining access to high quality health care for 
Medicare beneficiaries is, and will continue to be, a high priority, 
and we will monitor available relevant data. However, we do not 
anticipate that the implementation of resource-based practice expense 
RVUs should lead to any major impediments to access to care. Any 
impacts of this new system are being transitioned in over a 4-year 
period, during which we will be refining both the practice expense per 
hour data and the direct cost inputs. We will be working closely with 
the medical community during this refinement period, and we are 
confident that we will achieve a resource-based practice expense system 
that will maintain our beneficiaries' access to the best possible 
medical care.
    Comment: One commenter was concerned about how the monthly 
capitated payment for end-stage renal disease (ESRD) services was 
handled under the top-down approach. The commenter argued that, though 
the ``building block'' process used for the work RVUs for these 
services does not translate perfectly for practice expense values, this 
approach should still be utilized to calculate the practice expense 
RVUs. In addition, the commenter questioned our choice of CPT 99213, a 
mid-level office visit, to calculate physician time for ESRD services.
    Response: We allocated the practice expense pool to ESRD services 
using the CPEP inputs, as we did for almost all other services. We also 
believe that the intensity of an average evaluation and management 
service provides a reasonable estimate of physician time. These issues 
can be further analyzed during refinement.
    Comment: Two commenters noted that costs associated with the 
supervision of diagnostic tests were not included in the technical 
component amounts.
    Response: In separate carrier manual instructions, we are revising 
the level of physician supervision required for many diagnostic 
services. For example, we are changing the requirements for most 
ultrasound procedures from personal or direct supervision to general 
supervision. We believe the required supervision for any remaining 
services that are at the personal supervision level are generally 
already reflected in the work RVUs. Therefore, we do not believe that 
there are additional costs for physician supervision.
    Comment: One commenter indicated that there will be a marked 
increase in the volume of services paid under the physician fee 
schedule as a result of BBA changes in payment for outpatient therapy 
services. The commenter maintained that this increase should not 
adversely affect future budget neutrality adjustments.
    Response: Although payment for these outpatient therapy services 
are based on payment amounts contained in the physician fee schedule, 
these services are not included as part of the fee schedule pool for 
budget neutrality calculations.
    Comment: One commenter argued that the budget neutrality adjustment 
is inappropriately applied because it does not recognize the savings 
provided by the elimination of the facility payments for endoscopic 
procedures that will move to the office setting.
    Response: The statute specifies that there shall be budget 
neutrality for physician fee schedule services. The budget neutrality 
adjustment does not take into account payments to facilities.
    Comment: Two commenters suggested that any fiscal adjustments made 
to comply with BBA should be reflected in the conversion factor, or 
other ratio, rather than be included in the calculation of the practice 
expense RVUs, so that other payer reimbursement would not be affected.
    Response: We do not completely understand these comments, but we 
believe the request is consistent with our practice of making budget-
neutrality adjustments on the conversion factor.
    Comment: Several commenters requested additional impact analyses 
such as--
    <bullet> Comparison of actual practice expense by specialty with 
expected practice expense payments, both by amount and by percent, for 
both our proposed practice expense payments and the current fee 
schedule practice expense RVUs;
    <bullet> Comparison of impacts by geographic area, including rural 
and urban impacts;
    <bullet> Analysis of impacts on hospital, academic, and community-
based physicians;
    <bullet> Analysis of total Medicare and non-Medicare impact using 
national claims case mix data; and
    <bullet> An analysis that would demonstrate to other payers the 
degree to which our proposed payment rates are less than actual 
practice costs.
    Response: We lack the data to provide some of the requested 
analyses. For example, we do not have national claims case mix data and 
are unaware of the existence of such data. With regard to rural and 
urban impacts, in the June 5, 1998 proposed rule we discussed the 
limitations of such analyses given the structure of the Medicare 
payment localities. We are unsure what the commenters are specifically 
requesting on the issue of actual costs since we have based the 
resource-based practice expense RVUs on the best available source of 
multi-specialty actual cost data: the SMS survey. Cost analyses at the 
individual practice level are problematic since, for example, we do not 
have physician cost reports, but we are open to concrete suggestions on 
how to perform such analyses. We also note that the Medicare public use 
files are an excellent source of data for commenters who wish to 
perform additional analyses that they believe are possible with the 
data sources available to us.
    Comment: One commenter requested that we make clear to Medicare 
contractors that hospital-based pathologists who incur technical 
component costs for nonhospital patients can be paid for both the 
technical and professional components.
    Response: This is a long-standing policy, and we are not aware of 
any general problems in this regard. However, we would be willing to 
discuss the issue with individual carriers if the commenter provides 
more specific information.
    Comment: One commenter recommended that we recalibrate the 
allocation of RVUs to the pools for physician work, practice expense 
and malpractice, as this allocation has remained constant since the 
resource-based relative value scale was implemented in 1992.
    Response: We are recalibrating the allocation this year to match 
the Medicare Economic Index (MEI) weights. For example, work goes from 
54.2 percent of the total to 54.5 percent, the practice expense portion 
goes from 41.0 percent to 42.3 percent, and the malpractice portion 
goes from 4.8 percent to 3.2 percent. (See Section II.D, ``Rebasing and 
Revising the Medicare Economic Index.'') In order to prevent the work 
RVUs from changing as a result of this, we are altering only the 
practice expense and malpractice RVUs. The changes to the practice 
expense and malpractice RVUs due to this are offset by an adjustment to 
the conversion factor.
    Comment: One commenter recommended that we should limit the 
magnitude of the changes in physician payments resulting from the shift 
to resource-based payment for practice

[[Page 58830]]

expenses by imposing some reasonable limit on payment increases and 
decreases for individual services. The commenter maintains that section 
1848(c)(4) of the Act, which authorizes the Secretary of Health and 
Human Services to, ``establish ancillary policies, as may be necessary 
to implement this section,'' provides statutory authority on which to 
base such a policy. The comment pointed out that we invoked this 
section in 1991 with reference to the transition to resource-based 
payment for physician work.
    Response: We believe that Congress intended the transition period 
to be the mechanism by which we would mitigate the impacts of any 
changes in payment brought about by the shift to resource-based 
practice expense. Therefore, we believe it would be inappropriate for 
us to impose further limits on payment increases or decreases.
    Comment: One commenter maintained that the proposal violates both 
the Regulatory Flexibility Act and the Paperwork Reduction Act of 1980 
because the adequate filings required in both of these Acts did not 
accompany the proposal. Additionally, the commenter stated that we did 
not cite any evidence to support its contention that a Regulatory 
Impact Statement is not required.
    Response: We had included a Paperwork Reduction Act (PRA) section 
in HCFA-1006-P that meets the requirements of the PRA of 1980.
    One commenter stated that we do not cite any evidence in either of 
our proposals to support our contention that no regulatory impact 
statement is required. There may be some confusion about the purpose of 
an impact statement and the difference between a regulatory impact 
statement and a regulatory impact analysis (RIA). A regulatory impact 
statement is a brief rational on why an analysis was not conducted. An 
RIA is a complete analysis based on recent available data and is more 
extensive.
    An RIA was conducted in the proposed rule of June 5, 1998 (63 FR 
30866). Absent this analysis, we would be required to furnish an impact 
statement. Therefore, there is no violation of either the RIA or 
Regulatory Flexibility Act requirements.
3. Other Practice Expense Policies

Site-of-Service Payment Differential

    As part of the resource-based practice expense initiative, we are 
replacing the current policy that systematically reduces the practice 
expense RVU by 50 percent for certain procedures performed in 
facilities with a policy that would generally identify two different 
levels (facility and nonfacility) of practice expense RVUs for each 
procedure code depending on the site-of-service.
    Some services, by the nature of their codes, are performed only in 
certain settings and will have only one level of practice expense RVU 
per code. Many of these are evaluation and management codes with code 
descriptions specific as to the site of service. Other services, such 
as most major surgical services with a 90-day global period, are 
performed entirely or almost entirely in the hospital, and we are 
generally providing a practice expense RVU only for the out-of-office 
or facility setting.
    In the majority of cases, however, we will provide both facility 
and nonfacility practice expense RVUs. The higher nonfacility practice 
expense RVUs are generally used to calculate payments for services 
performed in a physician's office and for services furnished to a 
patient in the patient's home, or facility or institution other than a 
hospital, skilled nursing facility (SNF), or ambulatory surgical center 
(ASC). For these services, the physician typically bears the cost of 
resources, such as labor, medical supplies, and medical equipment 
associated with the physician's service.
    The lower facility practice expense RVUs generally are used to 
calculate payments for physicians' services furnished to hospital, SNF, 
and ASC patients. The costs for nonphysicians' services and other 
items, including medical equipment and supplies, are typically borne by 
the hospital, by the SNF, or the ASC.
    We received the following comments on our site-of-service payment 
differential proposal.
    Comment: We received several comments concerning the 
appropriateness of our site-of-service proposal:
    <bullet> Several specialty groups commented that they agreed with 
eliminating the site-of-service differential and replacing it with two 
levels of payment.
    <bullet> A national specialty society representing 
gastroenterologists, as well as several hundred individual commenters, 
strongly opposed the elimination of the current site-of-service 
differential and replacement of it with the facility and nonfacility 
resource-based practice expense RVUs. The comments argued that we 
should not have established different practice expense RVUs for 
facility and nonfacility settings for gastrointestinal endoscopy codes 
43234 through 45385 because:
    <bullet> It is unsafe to do these procedures in the office and will 
thus jeopardize patient safety;
    <bullet> It creates an incentive to provide care in the 
inappropriate office setting; and
    <bullet> It is not authorized by legislation, is against the intent 
of BBA to have different payment levels for different settings, and is 
likely to result in legal challenge.
    The commenter recommended that we drop the office and out-of-office 
differential in practice expense payment.
    <bullet> One organization commented that our site-of-service 
proposal will exacerbate the ability to subsidize uncompensated care 
and suggested exempting teaching physicians from the new site-of-
service provision. It also suggested that HCFA should also monitor the 
effects of the site-of-service policy.
    <bullet> The AMA, the American Hospital Association, and three 
other organizations commented that payment differentials should not 
provide an incentive for physicians and patients to choose one site 
over another. Some physician groups are concerned that the differential 
will accelerate the shift of some services from facility to nonfacility 
settings at the expense of patient safety. They asserted that claims 
data on changes in place of service should be made available and this 
issue should be one focus of refinement efforts.
    Response: We believe that, to the extent that the differing RVUs 
for in-office and out-of-office services reflect the relative 
differences in practice costs for performing those services, we have 
not created incentives to provide services in inappropriate settings. 
We are required by both the Social Security Act Amendments of 1994 and 
BBA to develop resource-based practice expense RVUs, based on 
physicians' actual costs. All of our data indicate that physicians' 
practice expenses are higher in the office, where the physician must 
incur all the costs of staff, equipment, and supplies, than in a 
facility that provides and is paid separately for these resources. As 
the facility and nonfacility costs to the physician can vary by a 
considerable amount, we believe that adopting a single average payment 
for both sites would consistently underpay in-office procedures, and 
overpay those performed in a facility and would thus be inherently 
inequitable, not resource-based, and contrary to the intent of the law. 
Furthermore, we are not aware of any studies showing that codes 43234 
through 45385 are being unsafely performed in offices. We have complete

[[Page 58831]]

confidence that physicians will continue to exercise their best 
clinical judgment as to the most appropriate setting for their 
patients.
    Comment: One specialty society stated its support for the proposed 
change in the site-of-service payment, as long as it does not result in 
nonpayment for services actually provided. For example, there are no 
practice expense RVUs for emergenc