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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Western Area Power Administration

CFR Citation: 42 CFR Parts 405, 409, 410, 411, 414, 415, 424, 485, and 486

RIN ID: RIN 0938-AP18

CMS ID: [CMS-1403-P]

NOTICE: Part II

DOCUMENT ACTION: Proposed rule.

SUBJECT CATEGORY: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; Proposed Rule

DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than August 29, 2008.

DOCUMENT SUMMARY: This proposed rule would address proposed changes to Medicare Part B payment policy. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule also discusses refinements to resourcebased practice expense (PE) relative value units (RVUs); geographic practice cost indices (GPCI) changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); application of health professional shortage area (HPSA) bonus payments; payment for renal dialysis services; performance standards for mobile independent diagnostic testing facilities; and physician and nonphysician practitioners furnishing diagnostic testing services; a solicitation for comments regarding the use of the Federal Payment Levy Program to recover delinquent Federal tax debts; a proposed amendment to the exemption for computergenerated facsimile transmissions from the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for transmitting prescription and certain prescriptionrelated information for Part D covered drugs prescribed for Part D eligible individuals; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); revisions for rehabilitation agencies; therapyrelated technical corrections; the physician quality reporting initiative; physician selfreferral issues and antimarkup; beneficiary signature for nonemergency ambulance transport; the chiropractic services demonstration; educational requirements for nurse practitioners and clinical nurse specialists; qualifications of portable xray supplier personnel; the expiration of provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007; bonus payments for long ambulance transports; the annual update for clinical laboratory fees under the clinical laboratory fee schedule; physician certification/recertification for home health services; a prohibition concerning providers of sleep tests; organ retrieval; a revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges'' final rule; and, potentially misvalued services under the physician fee schedule.

SUMMARY: Health and Human Services Department, Centers for Medicare & Medicaid Services,


SUPPLEMENTAL INFORMATION

Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code [CMS1403P] and the specific ``issue identifier'' that precedes the section on which you choose to comment.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http:// www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 18007433951.

Table of Contents

To assist readers in referencing sections contained in this preamble, we are providing a 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 (CFR). Information on the regulation's impact appears throughout the preamble, and therefore, is not exclusively in section VI. of this proposed rule.
I. Background

A. Development of the Relative Value System

1. Work RVUs

2. Practice Expense Relative Value Units (PE RVUs)

3. ResourceBased Malpractice RVUs

4. Refinements to the RVUs

5. Adjustments to RVUs are Budget Neutral

B. Components of the Fee Schedule Payment Amounts

C. Most Recent Changes to the Fee Schedule

II. Provisions of the Proposed Regulation

A. ResourceBased Practice Expense (PE) Relative Value Units (RVUs)

1. Current Methodology

2. PE Proposals for CY 2009

B. Geographic Practice Cost Indices (GPCIs): Locality Discussion

C. Malpractice RVUs (TC/PC issue)

D. Medicare Telehealth Services

E. Specific Coding Issues related to Physician Fee Schedule

F. Part B Drug Payment

1. Average Sales Price (ASP) Issues

2. Competitive Acquisition Program (CAP) Issues

G. Application of the HPSA Bonus Payment

H. Provisions Related to Payment for Renal Dialysis Services Furnished by EndStage Renal Disease (ESRD) Facilities

I. Independent Diagnostic Testing Facility (IDTF) Issues

J. Physician and Nonphysician Practitioner (NPP) Enrollment Issues

K. Proposed Amendment to the Exemption for ComputerGenerated Facsimile Transmission from the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard for Transmitting Prescription and Certain PrescriptionRelated Information for Part D Eligible Individuals

L. Comprehensive Outpatient Rehabilitation Facilities (CORF) and Rehabilitation Agency Issues

M. Technical Corrections for TherapyRelated Issues

N. Physician SelfReferral and AntiMarkup Issues

O. Physician Quality Reporting Initiative

P. Discussion of Chiropractic Services Demonstration

Q. Educational Requirements for Nurse Practitioners and Clinical Nurse Specialists

R. Portable XRay Issue

S. Expiring Provisions and Related Discussions

T. Other Issues

1. Physician Certification (G0180) and Recertification (G0179) for MedicareCovered Home Health Services under a Home Health Plan of Care (POC) in the Home Health Prospective Payment System (HH PPS)

2. Prohibition Concerning Providers of Sleep Tests

3. Beneficiary Signature for Nonemergency Ambulance Transport Services

4. Solicitation of Comments and Data Pertaining to Physician Organ Retrieval Services

5. Revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges'' Final Rule
III. Potentially Misvalued Services under Physician Fee Schedule IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulation Text

Addendum AExplanation and Use of Addendum B

Addendum B2009 Relative Value Units and Related Information Used in Determining Medicare Payments for 2008

Addendum C[Reserved for Final Rule]

Addendum DProposed 2009 Geographic Adjustment Factors (GAFs)

Addendum EProposed 2009* Geographic Practice Cost Indices (GPCIs) by State and Medicare Locality

Addendum FMultiple Procedure Reduction Code List

Addendum GFY 2009 Wage Index for Urban Areas Based On CBSA Labor Market Areas (ESRD)

Addendum HFY 2009 Wage Index based on CBSA Labor Market Areas for Rural Areas (ESRD)

Acronyms

In addition, because of the many organizations and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below:
ACC American College of Cardiology
ACR American College of Radiology
AFROC Association of Freestanding Radiation Oncology Centers AHA American Heart Association
[[Page 38504]]
AHRQ [HHS'] Agency for Healthcare Research and Quality
AIDS Acquired immune deficiency syndrome
AMA American Medical Association
AMP Average manufacturer price
AOA American Osteopathic Association
ASC Ambulatory surgical center
ASP Average sales price
ASRT American Society of Radiologic Technologists
ASTRO American Society for Therapeutic Radiology and Oncology ATA American Telemedicine Association
AWP Average wholesale price
BBA Balanced Budget Act of 1997 (Pub. L. 10533)
BBRA [Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106113)
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106554)
BLS Bureau of Labor Statistics
BN Budget neutrality
CABG Coronary artery bypass graft
CAD Coronary artery disease
CAH Critical access hospital
CAHEA Committee on Allied Health Education and Accreditation CAP Competitive acquisition program
CBSA CoreBased Statistical Area
CCHIT Certification Commission for Healthcare Information Technology CEAMA Council on Education of the American Medical Association CF Conversion factor
CfC Conditions for Coverage
CFR Code of Federal Regulations
CKD Chronic kidney disease
CLFS Clinical laboratory fee schedule
CMA California Medical Association
CMP Civil money penalty
CMS Centers for Medicare & Medicaid Services
CNS Clinical nurse specialist
CoP Condition of participation
CORF Comprehensive Outpatient Rehabilitation Facility
CPAP Continuous positive air pressure
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPIU Consumer price index for urban customers
CPT [Physicians'] Current Procedural Terminology (4th Edition, 2002, copyrighted by the American Medical Association)
CRT Certified respiratory therapist
CY Calendar year
DHS Designated health services
DME Durable medical equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and supplies
DNP Doctor of Nursing Practice
DRA Deficit Reduction Act of 2005 (Pub. L. 109171)
DSMT Diabetes selfmanagement training
E/M Evaluation and management
EDI Electronic data interchange
EEG Electroencephalogram
EHR Electronic health record
EKG Electrocardiogram
EMG Electromyogram
EOG Electrooculogram
EPO Erythopoeitin
ESRD Endstage renal disease
FAX Facsimile
FDA Food and Drug Administration (HHS)
FFS Feeforservice
FMS [Department of the Treasury's] Financial Management Service FPLP Federal Payment Levy Program
FR Federal Register
GAF Geographic adjustment factor
GAO General Accounting Office
GPO Group purchasing organization
GPCI Geographic practice cost index
HAC Hospitalacquired conditions
HCPAC Health Care Professional Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HH PPS Home Health Prospective Payment System
HHA Home health agency
HHRG Home health resource group
HHS [Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104191)
HIT Health information technology
HITSP Healthcare Information Technology Standards Panel
HIV Human immunodeficiency virus
HPSA Health Professional Shortage Area
HRSA Health Resources Services Administration (HHS)
ICF Intermediate care facilities
ICR Information collection requirement
IDTF Independent diagnostic testing facility
IFC Interim final rule with comment period
IPPS Inpatient prospective payment system
IRS Internal Revenue Service
IVIG Intravenous immune globulin
IWPUT Intraservice work per unit of time
JRCERT Joint Review Committee on Education in Radiologic Technology MA Medicare Advantage
MAPD Medicare AdvantagePrescription Drug Plans
MedCAC Medicare Evidence Development and Coverage Advisory Committee (formerly the Medicare Coverage Advisory Committee (MCAC))
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MIEATRHCA Medicare Improvements and Extension Act of 2006 (that is, Division B of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109432)
MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108173)
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110173)
MNT Medical nutrition therapy
MP Malpractice
MPPR Multiple procedure payment reduction
MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102539) MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSDRG Medicare SeverityDiagnosis related group
MSA Metropolitan statistical area
NCD National Coverage Determination
NCPDP National Council for Prescription Drug Programs
NDC National drug code
NISTA National Institute of Standards and Technology Act
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995 (Pub. L. 104113)
OACT [CMS'] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
OIG Office of Inspector General
OMB Office of Management and Budget
ONC [HHS'] Office of the National Coordinator for Health Information Technology
OPPS Outpatient prospective payment system
OSA Obstructive Sleep Apnea
OSCAR Online Survey and Certification and Reporting
P4P Pay for performance
PA Physician assistant
PC Professional component
PCF Patient compensation fund
PDP Prescription drug plan
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PERC Practice Expense Review Committee
PFS Physician Fee Schedule
PIM [Medicare] Program Integrity Manual
PLI Professional liability insurance
POC Plan of care
PPI Producer price index
PPS Prospective payment system
PQRI Physician Quality Reporting Initiative
PRA Paperwork Reduction Act
PSA Physician scarcity areas
PSG Polysomnography
PT Physical therapy
RFA Regulatory Flexibility Act
RIA Regulatory impact analysis
RN Registered nurse
RNAC Reasonable net acquisition cost
RRT Registered respiratory therapist
RUC [AMA's Specialty Society] Relative (Value) Update Committee RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SLP Speechlanguage pathology
SMS [AMA's] Socioeconomic Monitoring System
SNF Skilled nursing facility
SOR System of record
TC Technical Component
TIN Tax identification number
TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109432) UPMC University of Pittsburgh Medical Center
USDE United States Department of Education
VBP Valuebased purchasing
WAMP Widely available market price
I. Background
[If you choose to comment on issues in this section, please include the
[[Page 38505]]

caption ``BACKGROUND'' at the beginning of your comments.]

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), ``Payment for Physicians' Services.'' The Act requires that payments under the physician fee schedule (PFS) be based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resourcebased relative value system, Medicare payment for physicians' services was based on reasonable charges.
A. Development of the Relative Value System

1. Work RVUs

The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101239), and OBRA 1990, (Pub. L. 101508). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resourcebased, and the PE and malpractice RVUs were based on average allowable charges.

The physician work RVUs established for the implementation of the fee schedule in January 1992 were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human Services (DHHS). In constructing the codespecific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.

Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide. We established a separate conversion factor (CF) for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.

We establish physician work RVUs for new and revised codes based on recommendations received from the American Medical Association's (AMA) Specialty Society Relative Value Update Committee (RUC).

2. Practice Expense Relative Value Units (PE RVUs)

Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103432), enacted on October 31, 1994, amended section
1848(c)(2)(C)(ii) of the Act and required us to develop resourcebased PE RVUs for each physician's service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.

Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 10533), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resourcebased PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4year transition period from chargebased PE RVUs to resourcebased RVUs.

We established the resourcebased PE RVUs for each physician's service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resourcebased system for PE over a 4year period, resourcebased PE RVUs did not become fully effective until 2002.

This resourcebased system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and outofoffice setting. We have since refined and revised these inputs based on recommendations from the RUC. The AMA's SMS data provided aggregate specialtyspecific information on hours worked and PEs.

Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department. The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS. The nonfacility RVUs reflect all of the direct and indirect PEs of providing a particular service.

Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106113) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating PE RVUs beginning in CY 2007 and provided for a 4year transition for the new PE RVUs under this new methodology. We will continue to evaluate this policy and proposed necessary revisions through future rulemaking.

3. ResourceBased Malpractice (MP) RVUs

Section 4505(f) of the BBA amended section 1848(c) of the Act requiring us to implement resourcebased malpractice (MP) RVUs for services furnished on or after 2000. The resourcebased MP RVUs were implemented in the PFS final rule published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physicianowned insurers from all the States, the District of Columbia, and Puerto Rico.

4. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5 years. The first 5Year Review of the physician work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The second 5Year Review was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The third 5Year Review of physician work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. (Note: Additional codes relating to the third 5
[[Page 38506]]
Year Review of physician work RVUs were addressed in the CY 2008 PFS final rule with comment period (72 FR 66360).)

In 1999, the AMA's RUC established the Practice Expense Advisory Committee (PEAC) for the purpose of refining the direct PE inputs. Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new methodology for determining resourcebased PE RVUs and are transitioning this over a 4year period.

In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first 5Year Review of the MP RVUs (69 FR 66263). 5. Adjustments to RVUs are Budget Neutral

Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if adjustments to RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

As explained in the CY 2007 PFS final rule with comment period (71 FR 69624), due to the increase in work RVUs resulting from the third 5 Year Review of physician work RVUs, we applied a separate budget neutrality (BN) adjustor to the work RVUs for services furnished during 2007. This approach is consistent with the method we use to make BN adjustments to the PE RVUs to reflect the changes in these PE RVUs. B. Components of the Fee Schedule Payment Amounts

To calculate the payment for every physician's service, the components of the fee schedule (physician work, PE, and MP RVUs) are adjusted by a geographic practice cost index (GPCI). The GPCIs reflect the relative costs of physician work, PE, and malpractice insurance in an area compared to the national average costs for each component.

RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).

The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as: Payment = [(RVU work x budget neutrality adjustor (round product to two decimal places) x GPCI work) + (RVU PE x GPCI PE) + (RVU malpractice x GPCI malpractice)] x CF.

C. Most Recent Changes to the Fee Schedule

The CY 2008 PFS final rule with comment period (72 FR 66222) addressed certain provisions of Division B of the Tax Relief and Health Care Act of 2006Medicare Improvements and Extension Act of 2006 (Pub. L. 109432) (MIEATRHCA), and made other changes to Medicare Part B payment policy to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. The CY 2008 PFS final rule with comment period also discussed refinements to resourcebased PE RVUs; GPCI changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues including additional codes from the 5Year Review; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); clinical lab fee schedule issues; payment for endstage renal dialysis (ESRD) services; performance standards facilities; expiration of the physician scarcity area (PSA) bonus payment; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); a process for updating the drug compendia; physician selfreferral issues; beneficiary signature for ambulance transport services; durable medical equipment (DME) update; the chiropractic services demonstration; a Medicare economic index (MEI) data change; technical corrections; standards and requirement related to therapy services under Medicare Parts A and B; revisions to the ambulance fee schedule; the ambulance inflation factor for CY 2008; and an amendment to the eprescribing exemption for computergenerated facsimile transmissions

We also finalized the calendar year (CY) 2007 interim RVUs and issued interim RVUs for new and revised procedure codes for CY 2008.

In accordance with section 1848(d)(1)(E)(i) of the Act, we also announced that the PFS update for CY 2008 is 10.1 percent, the initial estimate for the sustainable growth rate (SGR) for CY 2008 is 2.2 percent and the CF for CY 2008 is $34.0682. However, subsequent to publication of the CY 2008 PFS final rule with comment period, section 101(a) of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110173) (MMSEA) was enacted on December 29, 2007 and provided for a 0.5 percent update to the conversion factor for the period beginning January 1, 2008 and ending June 30, 2008. Therefore, for the first half of 2008 (that is, January through June), the Medicare PFS conversion factor was $38.0870. For the remaining portion of 2008 (July through December), the Medicare PFS conversion factor will be $34.0682 (as published in the 2008 PFS final rule with comment period).
II. Provisions of the Proposed Regulation
A. ResourceBased Practice Expense (PE) Relative Value Units (RVUs) [If you choose to comment on issues in this section, please include the caption ``RESOURCEBASED PE RVUs'' at the beginning of your comments.]

Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act.

Section 121 of the Social Security Amendments of 1994 (Pub. L. 103 432), enacted on October 31, 1994, required CMS to develop a methodology for a resourcebased system for determining PE RVUs for each physician's service. Until that time, PE RVUs were based on historical allowed charges. This legislation stated that the revised PE methodology must consider the staff, equipment, and supplies used in the provision of various medical and surgical services in various settings beginning in 1998. The Secretary has interpreted this to mean that Medicare payments for each service would be based on the relative PE resources typically involved with furnishing the service.

The initial implementation of resourcebased PE RVUs was delayed from January 1, 1998, until January 1, 1999, by section 4505(a) of the BBA. In addition, section 4505(b) of the BBA required that the new payment methodology be phased in over 4 years, effective for services furnished in CY 1999, and fully effective in CY 2002. The first step toward implementation of the statute was to adjust the PE values for certain services for CY 1998. Section 4505(d) of the BBA required that, in developing the resourcebased PE RVUs, the Secretary must [[Page 38507]]

  • Use, to the maximum extent possible, generallyaccepted cost accounting principles that recognize all staff, equipment, supplies, and expenses, not solely those that can be linked to specific procedures and actual data on equipment utilization.
  • Develop a refinement method to be used during the transition.
  • Consider, in the course of notice and comment rulemaking, impact projections that compare new proposed payment amounts to data on actual physician PE.

    In CY 1999, we began the 4year transition to resourcebased PE RVUs utilizing a ``topdown'' methodology whereby we allocated aggregate specialtyspecific practice costs to individual procedures. The specialtyspecific PEs were derived from the American Medical Association's (AMA's) Socioeconomic Monitoring Survey (SMS). In addition, under section 212 of the BBRA, we established a process extending through March 2005 to supplement the SMS data with data submitted by a specialty. The aggregate PEs for a given specialty were then allocated to the services furnished by that specialty on the basis of the direct input data (that is, the staff time, equipment, and supplies) and work RVUs assigned to each CPT code.

    For CY 2007, we implemented a new methodology for calculating PE RVUs. Under this new methodology, we use the same data sources for calculating PE, but instead of using the ``topdown'' approach to calculate the direct PE RVUs, under which the aggregate direct and indirect costs for each specialty are allocated to each individual service, we now utilize a ``bottomup'' approach to calculate the direct costs. Under the ``bottom up'' approach, we determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the AMA's Relative Value Update Committee (RUC). For a more detailed explanation of the PE methodology see the June 29, 2006 proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
    1. Current Methodology

    a. Data Sources for Calculating Practice Expense

    The AMA's SMS survey data and supplemental survey data from the specialties of cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, gastroenterology, radiology, independent diagnostic testing facilities (IDTFs), radiation oncology, and urology are used to develop the PE per hour (PE/HR) for each specialty. For those specialties for which we do not have PE/HR, the appropriate PE/HR is obtained from a crosswalk to a similar specialty.

    The AMA developed the SMS survey in 1981 and discontinued it in 1999. Beginning in 2002, we incorporated the 1999 SMS survey data into our calculation of the PE RVUs, using a 5year average of SMS survey data. (See the CY 2002 PFS final rule with comment period (66 FR 55246).) The SMS PE survey data are adjusted to a common year, 2005. The SMS data provide the following six categories of PE costs:

  • Clinical payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician clinical personnel.
  • Administrative payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician personnel involved in administrative, secretarial, or clerical activities.
  • Office expenses, which include expenses for rent, mortgage interest, depreciation on medical buildings, utilities, and telephones.
  • Medical material and supply expenses, which include expenses for drugs, xray films, and disposable medical products.
  • Medical equipment expenses, which include depreciation, leases, and rent of medical equipment used in the diagnosis or treatment of patients.
  • All other expenses, which include expenses for legal services, accounting, office management, professional association memberships, and any professional expenses not previously mentioned in this section.

    In accordance with section 212 of the BBRA, we established a process to supplement the SMS data for a specialty with data collected by entities and organizations other than the AMA (that is, those entities and organizations representing the specialty itself). (See the Criteria for Submitting Supplemental Practice Expense Survey Data interim final rule with comment period (65 FR 25664).) Originally, the deadline to submit supplementary survey data was through August 1, 2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was extended through August 1, 2003. To ensure maximum opportunity for specialties to submit supplementary survey data, we extended the deadline to submit surveys until March 1, 2005 in the Revisions to Payment Policies Under the Physician Fee Schedule for CY 2004 final rule with comment period (68 FR 63196) (hereinafter referred to as CY 2004 PFS final rule with comment period).

    The direct cost data for individual services were originally developed by the Clinical Practice Expert Panels (CPEP). The CPEP data include the supplies, equipment, and staff times specific to each procedure. The CPEPs consisted of panels of physicians, practice administrators, and nonphysicians (for example, RNs) who were nominated by physician specialty societies and other groups. There were 15 CPEPs consisting of 180 members from more than 61 specialties and subspecialties. Approximately 50 percent of the panelists were physicians.

    The CPEPs identified specific inputs involved in each physician's service provided in an office or facility setting. The inputs identified were the quantity and type of nonphysician labor, medical supplies, and medical equipment.

    In 1999, the AMA's RUC established the Practice Expense Advisory Committee (PEAC). From 1999 to March 2004, the PEAC, a multispecialty committee, reviewed the original CPEP inputs and provided us with recommendations for refining these direct PE inputs for existing CPT codes. Through its last meeting in March 2004, the PEAC provided recommendations for over 7,600 codes which we have reviewed and almost all of which we have accepted. As a result, the current PE inputs differ markedly from those originally recommended by the CPEPs. The PEAC has now been replaced by the Practice Expense Review Committee (PERC), which acts to assist the RUC in recommending PE inputs. b. Allocation of PE to Services

    The aggregate level specialtyspecific PEs are derived from the AMA's SMS survey and supplementary survey data. To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
    (i) Direct costs. The direct costs are determined by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide the service. The costs of these resources are calculated from the refined direct PE inputs in our PE database. These direct inputs are then scaled to the current aggregate pool of direct PE RVUs. The aggregate pool
    [[Page 38508]]
    of direct PE RVUs can be derived using the following formula: (PE RVUs x physician CF) x (average direct percentage from SMS / (Supplemental PE/HR data)).
    (ii) Indirect costs. The SMS and supplementary survey data are the source for the specialtyspecific aggregate indirect costs used in our PE calculations. Then, we allocate the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the maximum of either the clinical labor costs or the physician work RVUs. For calculation of the 2009 PE RVUs, we are proposing to use the 2007 procedurespecific utilization data crosswalked to 2008 services. To arrive at the indirect PE costs

  • We apply a specialtyspecific indirect percentage factor to the direct expenses to recognize the varying proportion that indirect costs represent of total costs by specialty. For a given service, the specific indirect percentage factor to apply to the direct costs for the purpose of the indirect allocation is calculated as the weighted average of the ratio of the indirect to direct costs (based on the survey data) for the specialties that furnish the service. For example, if a service is furnished by a single specialty with indirect PEs that were 75 percent of total PEs, the indirect percentage factor to apply to the direct costs for the purposes of the indirect allocation would be (0.75 / 0.25) = 3.0. The indirect percentage factor is then applied to the service level adjusted indirect PE allocators.
  • We use the specialtyspecific PE/HR from the SMS survey data, as well as the supplemental surveys for cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, radiology, gastroenterology, IDTFs, radiation oncology, and urology. (Note: For radiation oncology, the data represent the combined survey data from the American Society for Therapeutic Radiology and Oncology (ASTRO) and the Association of Freestanding Radiation Oncology Centers (AFROC)). As discussed in the CY 2008 PFS final rule with comment period (72 FR 66233), the PE/HR survey data for radiology is weighted by practice size. We incorporate this PE/HR into the calculation of indirect costs using an index which reflects the relationship between each specialty's indirect scaling factor and the overall indirect scaling factor for the entire PFS. For example, if a specialty had an indirect practice cost index of 2.00, this specialty would have an indirect scaling factor that was twice the overall average indirect scaling factor. If a specialty had an indirect practice cost index of 0.50, this specialty would have an indirect scaling factor that was half the overall average indirect scaling factor.
  • When the clinical labor portion of the direct PE RVU is greater than the physician work RVU for a particular service, the indirect costs are allocated based upon the direct costs and the clinical labor costs. For example, if a service has no physician work and 1.10 direct PE RVUs, and the clinical labor portion of the direct PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65 clinical labor portions of the direct PE RVUs to allocate the indirect PE for that service.

    c. Facility/Nonfacility Costs

    Procedures that can be furnished in a physician's office, as well as in a hospital or facility setting, have two PE RVUs: Facility and nonfacility. The nonfacility setting includes physicians' offices, patients' homes, freestanding imaging centers, and independent pathology labs. Facility settings include hospitals, ambulatory surgical centers (ASCs), and skilled nursing facilities (SNFs). The methodology for calculating PE RVUs is the same for both facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because the PEs for services provided in a facility setting are generally included in the payment to the facility (rather than the payment to the physician under the PFS), the PE RVUs are generally lower for services provided in the facility setting.
    d. Services With Technical Components (TCs) and Professional Components (PCs)

    Diagnostic services are generally comprised of two components: A professional component (PC) and a technical component (TC), both of which may be performed independently or by different providers. When services have TCs, PCs, and global components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottomup methodology.)

    e. Transition Period

    As discussed in the CY 2007 PFS final rule with comment period (71 FR 69674), we are implementing the change in the methodology for calculating PE RVUs over a 4year period. During this transition period, the PE RVUs will be calculated on the basis of a blend of RVUs calculated using our methodology described previously in this section (weighted by 25 percent during CY 2007, 50 percent during CY 2008, 75 percent during CY 2009, and 100 percent thereafter), and the CY 2006 PE RVUs for each existing code. PE RVUs for codes that are new during this period will be calculated using only the current PE methodology and will be paid at the fully transitioned rate.

    f. PE RVU Methodology

    The following is a description of the PE RVU methodology. (i) Setup File

    First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialtyspecific survey PE per physician hour data.
    (ii) Calculate the Direct Cost PE RVUs

    Sum the costs of each direct input.

    Step 1: Sum the direct costs of the inputs for each service. The direct costs consist of the costs of the direct inputs for clinical labor, medical supplies, and medical equipment. The clinical labor cost is the sum of the cost of all the staff types associated with the service; it is the product of the time for each staff type and the wage rate for that staff type. The medical supplies cost is the sum of the supplies associated with the service; it is the product of the quantity of each supply and the cost of the supply. The medical equipment cost is the sum of the cost of the equipment associated with the service; it is the product of the number of minutes each piece of equipment is used in the service and the equipment cost per minute. The equipment cost per minute is calculated as described at the end of this section.

    Apply a BN adjustment to the direct inputs.

    Step 2: Calculate the current aggregate pool of direct PE costs. To do this, multiply the current aggregate pool of total direct and indirect PE costs (that is, the current aggregate PE RVUs multiplied by the CF) by the average direct PE percentage from the SMS and supplementary specialty survey data.

    Step 3: Calculate the aggregate pool of direct costs. To do this, for all PFS
    [[Page 38509]]
    services, sum the product of the direct costs for each service from Step 1 and the utilization data for that service.

    Step 4: Using the results of Step 2 and Step 3 calculate a direct PE BN adjustment so that the proposed aggregate direct cost pool does not exceed the current aggregate direct cost pool and apply it to the direct costs from Step 1 for each service.

    Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the Medicare PFS CF.
    (iii) Create the indirect PE RVUs

    Create indirect allocators.

    Step 6: Based on the SMS and supplementary specialty survey data, calculate direct and indirect PE percentages for each physician specialty.

    Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs we are calculating the direct and indirect percentages across the global components, PCs, and TCs. That is, the direct and indirect percentages for a given service (for example, echocardiogram) do not vary by the PC, TC and global component.

    Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVU, the clinical PE RVU, and the work RVU.

    For most services the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + work RVU.

    There are two situations where this formula is modified:

  • If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE RVU + work RVU.
  • If the clinical labor PE RVU exceeds the work RVU (and the service is not a global service), then the indirect allocator is: indirect percentage * (direct PE RVU/direct percentage) + clinical PE RVU.

    Note: For global services, the indirect allocator is based on both the work RVU and the clinical labor PE RVU. We do this to recognize that, for the professional service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVU and the clinical labor PE RVU. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.
    )For presentation purposes in the examples in Table 1, the formulas were divided into two parts for each service. The first part does not vary by service and is the indirect percentage * (direct PE RVU/direct percentage). The second part is either the work RVU, clinical PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVU exceeds the work RVU (as described earlier in this step).

    Apply a BN adjustment to the indirect allocators.

    Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indirect PE percentage from the physician specialty survey data. This is similar to the Step 2 calculation for the direct PE RVUs.

    Step 10: Calculate an aggregate pool of proposed indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service. This is similar to the Step 3 calculation for the direct PE RVUs.

    Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. This is similar to the Step 4 calculation for the direct PE RVUs.

    Calculate the Indirect Practice Cost Index.

    Step 12: Using the results of Step 11, calculate aggregate pools of specialtyspecific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

    Step 13: Using the specialtyspecific indirect PE/HR data, calculate specialtyspecific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service.

    Step 14: Using the results of Step 12 and Step 13, calculate the specialtyspecific indirect PE scaling factors as under the current methodology.

    Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

    Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (NOTE: For services with TCs and PCs, we calculate the indirect practice cost index across the global components, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC and global component.)

    Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVU.

    (iv) Calculate the Final PE RVUs

    Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17.

    Step 19: Calculate and apply the final PE BN adjustment by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See ``Specialties excluded from ratesetting calculation'' below in this section.)
    (v) Setup File Information

  • Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties such as midlevel practitioners paid at a percentage of the PFS, audiology, and low volume specialties from the calculation. These specialties are included for the purposes of calculating the BN adjustment.
  • Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
  • Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
  • Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVU. For example, the professional service code 93010 is associated with the global code 93000.
  • Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.
    [[Page 38510]]
  • Work RVUs: The setup file contains the work RVUs from this proposed rule.
    (vi) Equipment Cost per Minute

    The equipment cost per minute is calculated as:
    (1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 + interest rate) * life of equipment)))) + maintenance)
    Where:
    minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); 150,000 minutes.
    usage = equipment utilization assumption; 0.5.
    price = price of the particular piece of equipment.
    interest rate = 0.11.
    life of equipment = useful life of the particular piece of equipment.

    maintenance = factor for maintenance; 0.05.

    Note: To illustrate the PE calculation, in Table 1 we have used the conversion factor (CF) of $34.0682 which was published in the CY 2008 PFS final rule with comment period.
    [[Page 38511]]
    Table 1.Calculation of PE RVUs Under Methodology for Selected Codes 99213 Office 33533 CABG, 93000 ECG, Step Source Formula visit, est arterial, single 71020 Chest xray 71020TC Chest x 7102026 Chest x complete 93005 ECG, tracing 93010 ECG, report Nonfacility Facility Nonfacility ray Nonfacility ray Nonfacility Nonfacility Nonfacility Nonfacility (1) Labor cost (Lab)................. Step 1................. AMA.................... ....................... $13.32 $77.52 $5.74 $5.74 $ $6.12 $6.12 $ (2) Supply cost (Sup)................ Step 1................. AMA.................... ....................... $2.98 $7.34 $3.39 $3.39 $ $1.19 $1.19 $ (3) Equipment cost (Eqp)............. Step 1................. AMA.................... ....................... $0.19 $0.65 $8.17 $8.17 $ $0.12 $0.12 $ (4) Direct cost (Dir)................ Step 1................. ....................... =(1)+(2)+(3)........... $16.50 $85.51 $17.31 $17.31 $ $7.43 $7.43 $ (5) Direct adjustment (Dir Adj)...... Steps 24.............. See footnote*.......... ....................... 0.592 0.592 0.592 0.592 0.592 0.592 0.592 0.592 (6) Adjusted labor................... Steps 24.............. =Lab*Dir Adj........... =(1)*(5)............... $7.88 $45.88 $3.40 $3.40 $ $3.62 $3.62 $ (7) Adjusted supplies................ Steps 24.............. =Sup*Dir Adj........... =(2)*(5)............... $1.77 $4.34 $2.01 $2.01 $ $0.71 $0.71 $ (8) Adjusted equipment............... Steps 24.............. =Eqp*Dir Adj........... =(3)*(5)............... $0.12 $0.39 $4.84 $4.84 $ $0.07 $0.07 $ (9) Adjusted direct.................. Steps 24.............. ....................... =(6)+(7)+(8)........... $9.76 $50.61 $10.24 $10.24 $ $4.40 $4.40 $ (10) Conversion Factor (CF).......... Step 5................. MFS.................... ....................... $34.0682 $34.0682 $34.0682 $34.0682 $34.0682 $34.0682 $34.0682 $34.0682 (11) Adj. labor cost converted....... Step 5................. =(Lab*Dir Adj)/CF...... =(6)/(10).............. $0.23 $1.35 $0.10 $0.10 $ $0.11 $0.11 $ (12) Adj. supply cost converted...... Step 5................. =(Sup*Dir Adj)/CF...... =(7)/(10).............. $0.05 $0.13 $0.06 $0.06 $ $0.02 $0.02 $ (13) Adj. equip cost converted....... Step 5................. =(Eqp*Dir Adj)/CF...... =(8)/(10).............. $0.00 $0.01 $0.14 $0.14 $ $0.00 $0.00 $ (14) Adj. direct cost converted...... Step 5................. ....................... =(11)+(12)+(13)........ $0.29 $1.49 $0.30 $0.30 $ $0.13 $0.13 $ (15) Wrk RVU* Wrk Scaler............. Setup File............. MFS.................... ....................... $0.81 $29.62 $0.19 $ $0.19 $0.15 $ $0.15 (16) Dirpct........................ Steps 6, 7............. Surveys................ ....................... 33.8% 32.6% 40.7% 40.7% 40.7% 37.7% 37.7% 37.7% (17) Indpct........................ Steps 6, 7............. Surveys................ ....................... 66.2% 67.4% 59.3% 59.3% 59.3% 62.3% 62.3% 62.3% (18) Ind. Alloc. formula (1st part).. Step 8................. See Step 8............. ....................... ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) ((14)/(16))*(17) (19) Ind. Alloc. (1st part).......... Step 8................. ....................... See (18)............... $0.56 $3.07 $0.44 $0.44 $ $0.21 $0.21 $ (20) Ind. Alloc. formulas (2nd part). Step 8................. See Step 8............. ....................... (15) (15) (15)+(11) (11) (15) (15)+(11) (11) (15) (21) Ind. Alloc. (2nd part).......... Step 8................. ....................... See (20)............... $0.81 $29.62 $0.29 $0.10 $0.19 $0.25 $0.11 $0.15 (22) Indirect Allocator (1st+2nd).... Step 8................. ....................... =(19)+(21)............. $1.37 $32.69 $0.73 $0.53 $0.19 $0.47 $0.32 $0.15 (23) Indirect Adjustment (Ind Adj)... Steps 911............. See footnote**......... ....................... 0.364 0.364 0.364 0.364 0.364 0.364 0.364 0.364 (24) Adjusted Indirect Allocator..... Steps 911............. =Ind Alloc * Ind Adj... ....................... $0.50 $11.89 $0.26 $0.19 $0.07 $0.17 $0.12 $0.05 (25) Ind.Practice Cost Index (PCI)... Steps 1216............ See Steps 1216........ ....................... $0.973 $0.934 $1.075 $1.075 $1.075 $1.281 $1.281 $1.281 (26) Adjusted Indirect............... Step 17................ = Adj. Ind Alloc*PCI... =(24)*(25)............. $0.49 $11.11 $0.28 $0.21 $0.07 $0.22 $0.15 $0.07 (27) PE RVU.......................... Steps 1819............ =(Adj Dir+Adj Ind) =((14)+(26)) *budn..... $0.77 $12.60 $0.59 $0.51 $0.07 $0.35 $0.28 $0.07 *budn. \*\ The direct adj = [current pe rvus * CF * avg dir pct] / [sum direct inputs] = [Step 2] / [Step 3]. \**\ The indirect adj = [current pe rvus * avg ind pct] / [sum of ind allocators] = [Step 9]/[Step 10. Note: Final PE RVU in Table 1, row 27, may not match Addendum B due to rounding. [[Page 38512]]
    2. PE Proposals for CY 2009

    a. RUC Recommendations for Direct PE Inputs

    The RUC provided recommendations for PE inputs for the codes listed in the Table 2.
    Table 2.Codes With RUC PE Recommendations
    CPT \1\ code Description
    29805........................ Shoulder arthroscopy, dx.
    29830........................ Elbow arthroscopy.
    29840........................ Wrist arthroscopy
    29870........................ Knee arthroscopy, dx.
    29900........................ Mcp joint arthroscopy, dx.
    90465........................ Immune admin 1 inj, <8 yrs.
    90466........................ Immune admin addl inj, <8 y. 90467........................ Immune admin o/n, addl <8 yrs. 90468........................ Immune admin o/n, addl <8 y. 90471........................ Immunization admin.
    90472........................ Immunization admin, each admin 90473........................ Immune admin oral/nasal
    90474........................ Immune admin oral/nasal addl. 93510........................ Left heart catheterization.
    96405........................ Chemo intralesional, up to 7. 96406........................ Chemo intralesional over 7.
    96440........................ Chemotherapy, intracavitary. 96445........................ Chemotherapy, intracavitary. 96450........................ Chemotherapy, into CNS.
    96542........................ Chemotherapy injection.
    99174........................ Ocular photoscreening.
    99185........................ Regional hypothermia.
    99186........................ Total body hypothermia.
    \1\ CPT codes and descriptions are copyright 2008 American Medical Association.

    We are in agreement with the RUC recommendations, (including the recommendation that no change be made to the direct inputs for CPT 93510, a cardiac catheterization code), except for inclusion of the clinical staff time related to quality activities for the following immunization codes: CPT codes 90465, 90466, 90467, 90468, 90471, 90472, 90473 and 90474. While we allow this time for mammography services due to the specific regulatory requirements required by the Mammography Quality Standards Act of 1992 (Pub. L. 102539) (MQSA), such MQSA time is not a regulatory requirement for immunization services.

    b. Equipment TimeinUse

    The formula for estimating the cost per minute for equipment is based upon a variety of factors, including the cost of the equipment, useful life, interest rate, maintenance cost, and utilization. The purpose of this formula is to identify an estimated cost per minute for the equipment that can be multiplied by the time the equipment is in use to obtain an estimated per use equipment cost to develop the resourcebased PE RVU.

    In calculating the estimated cost per minute for services that are in use 24 hours per day for 7 days per week, we have assumed that the maximum amount of time that the equipment can be in use is approximately 525,000 minutes (that is, 525,000 minutes = (24 hours per day) x (7 days per week) x (52 weeks per year) x (60 minutes per hour)).

    For CY 2008, we used 525,000 minutes to calculate the per minute equipment cost for the equipment used in CPT code 93012, Telephonic transmission of postsymptom electrocardiogram rhythm strip(s), 24hour attended monitoring, per 30 day period of time; tracing only and CPT code 93271, Patient demand single or multiple event recording with presymptom memory loop, 24hour attended monitoring, per 30 day period of time; monitoring, receipt of transmissions, and analysis. Based on information presented to us by a provider group suggesting that the equipment was in use continuously, we determined that this equipment is used 24 hours a day, 7 days a week. Thus, we assigned the equipment a 100 percent usage rate. However, in subsequent discussions with a provider group, we determined that, although there may be a 100 percent usage rate for a particular month, this does not correspond to a 100 percent usage rate for a year. Therefore, for CY 2009 we are proposing to apply our standard utilization rate of 50 percent to the 525,000 maximum minutes of use, consistent with our utilization rate assumption for other equipment. This results in 262,500 minutes (that is, 262,500 = 525,000 x 0.50) of average use over the course of the year.

    In the CY 2008 PFS rule, we used 43,200 minutes (60 minutes per hour x 24 hours per day x 30 days per month) to estimate the per use cost of the equipment in these monthly services. We are continuing to use 43,200 minutes in determining the equipment cost per use for these codes. The PE RVUs would increase from 5.28 to 5.98 as a result of this change.
    c. Change to PE Database Inputs for Certain Cardiac Stress Tests

    The direct PE inputs for CPT code 93025, Microvolt Twave alternans for assessment of ventricular arrhythmias, for clinical labor are not consistent with the other cardiac stress tests, CPT codes 93015, Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; with physician supervision, with interpretation and report, and 93017, Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous
    electrocardiographic monitoring, and/or pharmacological stress; tracing only, without interpretation and report. These codes were refined by the PEAC in January 2002, the same year that CPT code 93025 was implemented. Because of this overlap in timing, the codes that the PEAC refined utilize registered nurses (RNs) while CPT 93025 uses a ``blend'' of RNs and physicians.

    To provide consistency across the family, we are proposing to designate the RN as the labor type for CPT code 93025. In addition, we are proposing to add the specific Microvolt Twave testing equipment, priced at $40,000, to replace the two different cardiac stress testing treadmill devices that are currently assigned to this code and reflected in the PE database. We are also proposing to assign the service period time, 53 minutes, to the exam table and the Microvolt Twave testing treadmill because neither piece of equipment is available for use by others during the testing interval. The Twave stress test must be done in quiet room. Using this rationale for the other two stress testing CPT codes (that is, 93015 and 93017), we are also proposing to revise the PE database for these services and allocate the 55minute service period time to the exam table and the stress testing equipment rather than the 41 minutes currently assigned. d. Revisions to Sec. 414.22(b)(5)(i) Concerning Practice Expense

    Current regulations at Sec. 414.22(b)(5)(i) provide an explanation of the two levels of PE RVUsfacility and nonfacilitythat are used in determining payment under the PFS. Section 414.22(b)(5)(i)(A) discusses facility PE RVUs and Sec. 414.22 (b)(5)(i)(B) discusses nonfacility PE RVUs. Language in each of these sections incorrectly implies that the facility PE RVU is lower than or equal to the nonfacility PE RVU

    FOR FURTHER INFORMATION CONTACT

    Pam West, (410) 7862302, for issues related to practice expense.

    Rick Ensor, (410) 7865617, for issues related to practice expense methodology.

    Stephanie Monroe, (410) 7866864, for issues related to malpractice RVUs.

    Esther Markowitz, (410) 7864595, for issues related to telehealth services.

    Craig Dobyski, (410) 7864584, for issues related to geographic practice cost indices.

    Ken Marsalek, (410) 7864502, for issues related to the multiple procedure payment reduction for diagnostic imaging.

    Catherine Jansto, (410) 7867762, or Cheryl Gilbreath, (410) 786 5919, for issues related to payment for covered outpatient drugs and biologicals.

    Edmund Kasaitis, (410) 7860477, or Bonny Dahm (410) 7864006, for issues related to the Competitive Acquisition Program (CAP) for Part B drugs.

    Corrine Axelrod, (410) 7865620, for issues related to Health Professional Shortage Area Bonus Payments.

    [[Page 38503]]

    Henry Richter, (410) 7864562, for issues related to payments for endstage renal disease facilities.

    August Nemec, (410) 7860612, for issues related to independent diagnostic testing facilities and enrollment issues; and the revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges'' final rule.

    Lisa Ohrin, (410) 7864565, for issues related to incentive payment and shared saving programs.

    Don Romano, (410) 7861401, for issues related to antimarkup provisions.

    Diane Stern, (410) 7861133, for issues related to the quality reporting system for physician payment for CY 2009.

    Andrew Morgan, (410) 7862543, for issues related to the e prescribing exemption for computer generated fax transmissions.

    Terri Harris, (410) 7866830, for issues related to payment for comprehensive outpatient rehabilitation facilities (CORFs).

    Lauren Oviatt, (410) 7864683, for issues related to CORF conditions of coverage.

    Trisha Brooks, (410) 7864561, for issues related to personnel standards for portable xray suppliers.

    David Walczak, (410) 7864475, for issues related to beneficiary signature for nonemergency ambulance transport services.

    Jean Stiller, (410) 7860708, for issues related to the prohibition concerning providers of sleep tests

    Mark Horney, (410) 7864554, for issues related to the solicitation for comments and data pertaining to physician organ retrieval services.

    Diane Milstead, (410) 7863355, or Gaysha Brooks, (410) 7869649, for all other issues.


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