Via Courier January 5, 2004 Dennis G. Smith, Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1471-FC Room C5-14-03 7500 Security Boulevard Baltimore, MD 21224-1850 Re: Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rated; Final Rule With Comment Period Dear Administrator Dennis G. Smith: The American College of Radiology (ACR) appreciates the opportunity to comment on the 2004 Medicare Hospital Outpatient Prospective Payment System (HOPPS) final rule. The ACR represents over 32,000 radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists in the United States, who share a commitment to making diagnostic and therapeutic radiology safe, effective and accessible to those who medically need it. Given that over seventy percent of the ACR's members practice in hospital settings, the ACR is interested in working with the Centers for Medicare and Medicaid Services (CMS) on the structure and relative weights of Ambulatory Payment Classifications (APCs) to ensure an efficient and appropriate reimbursement system to hospitals that allows for high quality radiology and radiation oncology services to Medicare beneficiaries. Along with CMS, the ACR continues to support radiologists and radiation oncologists who provide Medicare services that are based on the best clinical decision for the patient and not on hospitals' administrative decisions driven by costs and reimbursements. Upon careful review of the 2004 HOPPS final rule, the ACR is generally pleased with many of the revisions to the HOPPS/APCs with respect to radiology and radiation oncology services. Implementation of these changes, in addition to educating the hospitals on capturing costs for these important procedures, is crucial in improving this payment system in the future. The ACR looks forward to continued work with CMS on the new payment system to ensure quality of radiology and radiation oncology patient care. Nuclear Medicine Reclassification New Nuclear Medicine APC Classification As a member of the Nuclear Medicine APC Task Force, the ACR is pleased with the 2004 HOPPS final rule improvements in the reclassification of the nuclear medicine procedures into the new organ-based APCs as advised by the task force. We share CMS's concern that a few APCs still violate the two-times rule and we look forward to working with the task force and CMS to further refine these APCs. In particular, the ACR would like CMS to consider the Myocardial PET APC 0285. The HCPCS codes for the myocardial PET procedures APC are G0030-G0047. In CY 2003, this APC had a payment rate of $945.47, and in the final rule the payment rate dropped 18.4% to $772.08. The ACR recommends CMS reconsider assigning these codes the proposed 2004 published rate of $945.47 under a "new technology APC" until accurate cost data can be gathered to establish a more appropriate payment rate for this procedure. Positron Emission Tomography (PET) The College is pleased with the transfer of PET procedures from new technology APCs into a separate APC 1516. The ACR is also pleased that CMS will create a new HCPCS code "G0296" in APC 1516 that will apply to PET for thyroid cancer under appropriate clinical circumstances. The ACR commends CMS for delaying the APC transfer until this time, which allowed CMS to gather more appropriate cost data and sufficient data to justify the new APC assignment. Separate Payment for Radiopharmaceuticals The ACR supports the final implementation of the $50 threshold for separate payment on radiopharmaceuticals. This will be especially beneficial for those radiopharmaceuticals that cost over $50 and can now be unbundled and have their costs captured for more appropriate reimbursement. Although CMS still needs to address other issues, such as the revenue codes for radiopharmaceuticals, a system that includes more claims in the calculation of APCs, and fixing the cost-to-charge ratio, this new regulation is a step forward in tracking the costs of radiopharmaceuticals and adequately establishing costs and revenues of the nuclear medicine department in hospitals. Medicare Legislation The ACR requests that CMS consider radiopharmaceuticals as "drugs" given that the recent legislation (H.R.1) clearly defines radiopharmaceuticals as such. The ACR also reserves the right for final comment on the rule once CMS processes changes due to passing legislation of the Medicare drug bill. The ACR is concerned with how CMS's translation and implementation of the legislation will reflect the incorporation of changes into the Medicare program in hospital outpatient departments. The ACR also urges CMS to implement payment updates for drugs, effective January 1, 2004, consistent with the new legislative authority. Descriptors The ACR emphasizes the need for new code descriptors to be "per dose" instead of "per mCi" for homogeneity of radiopharmaceutical coding procedures. The ACR continues to receive input from many hospital venues that inaccurate descriptions on dose amounts are confusing and problematic. Requiring a "per dose" descriptor, similar to the "unit of use" methodology, would appropriately account for the right dosage uniformly used and coded, better data reported, and thus, more appropriate payment levels. The ACR requests that CMS accept the APC Advisory Panel's August 2003 recommendation to implement a "per dose" coding criteria that would permit more accurate coding and reporting of costs of radiopharmaceuticals. The ACR also recommends that when CMS changes descriptors on radiopharmaceuticals, it makes sure the crosswalk of the payment rate is recalculated to match the current descriptor. Multiple Procedure Claims The ACR is pleased that CMS has unpackaged several radiology and radiation oncology procedures, which will facilitate better data that captures the costs associated with these procedures potentially leading to more accurate reimbursement. However, challenges still remain in developing a strategy to include multiple procedure claims in relative weight calculations. In high dose rate (HDR) brachytherapy procedures (APC 313), for example, in which multiple claims are often an inherent feature and represent a majority of claims submitted to CMS, the relative weight calculation is based on an insufficient number of single claims that lead to inadequate reimbursement for this procedure. The ACR is pleased that CMS is aware of this problem and is trying to explore new methods to include multiple claims in HOPPS payment rate calculations. Until a more efficient methodology is instituted, however, the ACR encourages CMS to continue to explore additional methodologies that are able to incorporate the use of more, if not all, multiple procedure claims for more appropriate reimbursement. This is critical if some of the costs of more complex therapies are to ever be established appropriately under APCs. The ACR recommends that CMS continue to work towards an appropriate methodology that is able to include more multiple procedure claims and appropriately account for all procedure costs. The ACR is also recommending that CMS consider selective external data for further cost analysis of these procedures, specifically for radiation oncology and interventional radiology. Separate Payment for Drugs for Monoclonal Antibodies Zevalin Coverage The ACR once again commends CMS's decision to make payment for "Zevalin" (Ibritumomab Tiuxetan) separately from payment for monoclonal antibody therapy administration for which "Zevalin" is used. This will allow the system to more accurately reflect the costs involved. Bexxar Coverage The ACR is pleased that CMS will establish two temporary C-codes for hospitals to use to bill under the OPPS for I-131 tositumomab for services furnished beginning January 1, 2004, as follows: C1080, Supply of radiopharmaceutical diagnostic imaging agent, I-131 tositumomab, per dose C1081, Supply of radiopharmaceutical therapeutic imaging agent, I-131 tositumomab, per dose The ACR believes that without a broad educational effort to clarify how to code for these monoclonal antibodies, other codes listing the same product as per mCi will cause confusion and can possibly lead to erroneous data. The ACR recommends that CMS work with the College to initiate an educational effort on how to code for Zevalin and Bexxar. Radiation Oncology Prostate Brachytherapy The ACR is pleased that CMS accepted the College's recommendation to pay separately for prostate brachytherapy services and delete the G codes (G0256, Prostate brachytherapy w/ iodine seed, and G0261, Prostate brachytherapy w/ Palladium) and APCs 0649 and 0684 used to bill for prostate brachytherapy in 2003. Unpackaging the prostate brachytherapy procedure and the sources will allow for a more efficient coding system in which more accurate costs are reported for proper reimbursement. The hospitals need to be educated about this change and instructed on how to code properly for prostate brachytherapy and related devices in 2004. Intensity Modulated Radiation Therapy (IMRT), APC 0412 The ACR is pleased that CMS agreed that the proposed reimbursement for intensity- modulated radiotherapy (IMRT) treatment planning (CPT® 77301) does not appropriately cover all the costs of this service and, therefore, should be kept in the "new technology" APC 1510 (with a payment rate of $850.00) to allow sufficient time for hospital education on how to properly code for this procedure. The ACR is disappointed, however, that CMS decided to move forward with the assignment of IMRT treatment delivery (CPT® 77418) to APC 0412 (IMRT Treatment Delivery). Under this new APC, payment for this important procedure decreased by 28.3%, from $400.00 in 2003 to $294.11 in 2004. The ACR is still concerned that this proposed amount remains too low to cover the costs associated with the procedure. In the ACR's comment letter to CMS on the 2004 HOPPS proposed rule, the College suggested that because both CPT® 77301 and 77418 are fairly new procedures, hospitals seem to be misreporting the complete costs of providing this expensive and staff-intensive procedure. To avoid inaccurate and underestimated median costs of these codes, the ACR recommended that CMS keep both codes in its 2003 "new technology" APC for 2004. As stated above, CMS was convinced that CPT® code 77301 was in fact receiving insufficient reimbursement. Since both CPT® procedures are performed together and should, therefore, show similar miscoding attributes, the ACR is confused as to why CMS denied code 77418 the same treatment as code 77301. The ACR recommends that CMS reconsider its decision regarding CPT® 77418 and keep this code in the "new technology" APC for 2004 until the cause of the significant decrease in median costs is examined and determined. In addition, keeping CPT® 77418 in the "new technology" APC would provide more time for the ACR to work with CMS on educating hospitals on how to code properly for this service. Treatment Delivery Codes, APC 301 (Level II Radiation Therapy) The ACR is very concerned about the 30% proposed reduction for APC 301 Level II Radiation Therapy in 2004, resulting in losses of approximately $155 million. The median costs in CMS's data do not reflect the costs of all the resources required to provide these services. These delivery codes are widely used, and a systematic method for identifying and using multiple claims, which reflect all costs of these procedures is necessary for a more accurate reimbursement payment. An entire radiation treatment usually takes one to eight weeks (depending on the type of cancer), and sometimes the patient receives radiation treatment twice a day. This represents a considerable reduction in payment per patient for hospitals. In addition to this proposed reduction of approximately $150 million in APC 301, the hospital radiation oncology departments are also faced with significant reductions in other areas (i.e. brachytherapy, IMRT), which can make it difficult for radiation oncology to continue as a viable hospital cost center, and thus, potentially jeopardize Medicare beneficiaries' access to radiation oncology care in hospital settings. Until CMS identifies an adequate system that collects representative cost data, the ACR recommends that CMS apply the same dampening method used in Device and Procedural APCs, in which the reductions are limited to the decrease in median costs by 15% plus ½ the amount of any reduction beyond 15%. High Dose Rate (HDR) Brachytherapy High Dose Rate (HDR) brachytherapy (APC 313) payment decreased by 19% from $1,097 in 2003 to $886.51 in the 2004 HOPPS final rule. The ACR understands CMS's argument that it was incorrectly paying for new seeds every time the brachytherapy procedure was performed instead of amortizing the payment across the lifespan of the radiation source that is used to treat multiple patients and multiple times. The ACR remains concerned, however, that the payment for the HDR brachytherapy is still inadequate even after the amortization is taken into account. It is estimated that the acquisition cost of the HDR source (Iridium-192) is approximately $10,000/source per quarter year ($40,000 per year total cost). This source continuously emits radiation until it is no longer active; therefore, the cost per patient varies according to the number of cases a hospital treats. A busier hospital that treats more patients accrues a smaller cost per patient than a hospital that treats fewer patients. The ACR understands that the variability in the source cost per patient does impose difficulty in determining accurate reimbursement; however, it should not justify ignoring these costs and basing 2004 payment rates on miscoded and insufficient claims. As indicated in the 2004 HOPPS Final Rule, CMS tried to acquire more claims that included the costs of specific items including, but not limited to, the HDR sources, needle, and/or catheters; however, no claims included both a source and a needle or catheter, which most likely indicates misreported claims. CMS was, therefore, only able to use single claims for which a HDR source (C1717) was reported to calculate the HDR payment rate. Although CMS closely examined the claims, the 2004 HOPPS payment is only based on 27 single claims (claims with only an HDR source but no claims that included both the source and the needles and/or catheters), which allowed median costs to increase slightly. The ACR, nevertheless, believes that the reimbursement calculated from the median costs still remain insufficient due to the omission of multiple claims (which in this procedure represents the majority of claims). The ACR would also like to express the importance of CMS's consideration of external data that can shed light on the total costs of these procedures, assisting CMS to reach a more reasonable and appropriate payment rate for HDR brachytherapy. In addition, the ACR recommends that CMS provide hospitals with clear instructions on how to code costs of the HDR source and supplies, as well as the procedure itself. The ACR recommends that CMS initiate a comprehensive educational effort to instruct hospitals on how to code correctly for all brachytherapy procedures and their related devices, including HDR, prostate and low dose rate brachytherapy procedures, so all costs can correctly be captured for future payment rates. The ACR also recommends that CMS consider accepting external survey data from specialty organizations that can reveal the true costs of these cancer therapies. Breast Brachytherapy, New "G" Codes For the pending CPT® codes for breast brachytherapy procedures, the ACR recommends the following HCPCS code descriptors and APC classifications: Description: Gxxxx: Placement of a radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following a partial mastectomy, includes imaging guidance; concurrent with partial mastectomy (List separately in addition to code for primary procedure) Assignment: New Technology APC 1523 Level XXIII ($2500 - 3000) Status Indicator S (device cost is 87.3% of cost of procedure) Description: Gxxxx: Placement of a radiotherapy afterloading balloon catheter into the breast for interstitial radioelement application following a partial mastectomy, includes imaging guidance; on date separate from partial mastectomy Assignment: New Technology APC 1524 Level XIV ($3000 - 3500) Status Indicator S (device cost is 73.8% of cost of procedure) The ACR also recommends that CMS add a third G code for "button-type" catheters for 2004 with the following description as approved by the CPT® Editorial Panel: Description: Gxxxx: Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time or subsequent to) a partial mastectomy, includes imaging guidance. Assignment: New Technology APC, Status Indicator S Stereotactic Radiosurgery APC 714 and 1528 SRS Treatment Delivery In 2004, two different classifications were given to the stereotactic radiosurgery (SRS) for treatment delivery under HCPCS G0173 (APC 1528, Linear accelerator based SRS…complete course of treatment in one session, $5,250), G0243 (APC 1528, Multi-source photon SRS…complete course of treatment in one session, $5,250), and G0251 (APC 1513, Linear accelerator based SRS, 2-5 sessions or "fractionated" therapy, $1,150). CMS has proposed to include two additional "G" codes describing "fractioned sessions" under G0340 (APC 1525, Image-guided robotic linear accelerator-based SRS, 2-5 sessions, $3,750), and G0339 (APC 1528, Image-guided robotic linear accelerator-based SRS, one/first session, $5,250). The ACR agrees that the payment rate for all types of SRS delivered in one session are consistent and representative of the costs of these services, however, the ACR opposes CMS's proposed APC classification for a "fractionated" therapy CPT® code G0340. The higher payment attributed to G0340 is inconsistent with clinically homogeneous APC classification and would create unwelcome financial incentives for hospitals to promote treatment using one type of SRS over another based on financial considerations rather than clinical indicators and efficacy. For a clinically homogeneous resource and costs classification, all "fractionated" SRS procedures should be grouped to the same APCs. G0340 SRS 2-5 sessions and G0251 SRS 2-5 sessions should, therefore, be assigned to the same APC. The ACR recommends that CMS group G0340 and G0251 to the same APC. The ACR also recommends that CMS continue to collect data on the different methods of SRS to accurately identify costs per the APC methodology. SRS Treatment Planning Treatment planning for SRS is currently coded under G0242 (APC 1516, Multi source photon SRS, Cobalt 60 multi-source converging beam plan, including dose volume histograms for target critical structure tolerances, plan optimization performed for highly conformal distributions, plan positional accuracy and dose verification, all lesions treated, per course of treatment, $1,450). The descriptor implies that the payment is only for a robotic-based system (i.e. Cyberknife). The Cyberknife is only one of a growing list of Federal Drug Administration (FDA)-approved devices (BrainLab Novalis, BrainLab ExacTrac X-ray 6D, TomoTherapy HI-ART2, Elekta Synergy, etc…) that can deliver imaged-guided SRS. It is the ACR's understanding that, to include other approved devices, CMS has proposed to add an additional code, G0338 (APC 1516, Linear accelerator-based SRS, plan, plan position, and dose verification, per course of treatment, $1,450), which does not restrict the source used to Cobalt. This new code, however, is unnecessary when a simpler alteration in the description of the already existing G0242 code would be sufficient to indicate additional devices and would require fewer, if any, instructions to hospitals on how to properly code for this particular procedure. To avoid unnecessary new additional codes, the ACR recommends that CMS change the description of G0242 to "include all SRS planning" and delete the phrase that restricts the multi-source use to Cobalt 60, instead of introducing code G0338. Low Osmolar Contrast Medium (LOCM) The ACR is disappointed that CMS continues to package low osmolar contrast medium (LOCM) instead of providing separate payment for this important drug. More problematic, the final rule indicates that CMS has established one new HCPCS code—A9525, supply of low or iso-osmolar contrast material, 10 mg of iodine and intends to delete three existing HCPCS codes A4644, A4645, and A4646, effective January 1, 2004. Excluding the four "A" codes and creating one new "A" code by which hospitals bill for LOCM in 10mg increments does not work. This will prevent CMS from capturing all the costs associated with the procedure. For example, if isoview was used for a CT with contrast study, 100 cc's would typically be needed, which translates to 300 mg. Hospitals would have to bill the new code 30 times in order to appropriately capture the costs of the Isoview. There needs to be a coding mechanism whereby hospitals identify and capture the dose used for each procedure. In addition, this coding change will raise significant new problems and confusion for hospitals and physicians as the typical doses of iodine in contrast-enhanced CT and CT angiography examinations are from 30 to 45 grams (not mg), thus requiring very large numbers of units of the proposed new "A" code. Therefore, we strongly recommend that CMS keep the existing "A" codes for LOCM. The decision to use LOCM depends on the study and clinical circumstance of each patient, in which the volume of contrast used from one person to the next may vary significantly. This variability in usage and Medicare's restrictive coverage of LOCM justifies a separate coverage coding method to ensure access for Medicare beneficiaries to this safer contrast material. If CMS is willing to recognize the safety and clinical advantages of LOCM and pay for LOCM for all the diagnostic imaging procedures for which iodinated contrast is needed, then an increase should be made in the relative weights of all radiology APCs that require iodinated contrast or, alternatively, CMS should consider paying for it separately in its own APC. The ACR recommends that CMS work with the ACR on appropriate LOCM reimbursement to include a universal coverage system for this important median contrast. This could be done by introducing separately paid APCs for this contrast medium or introduce a mechanism that accounts for additional costs of LOCM in APCs that include codes that involve the use of LOCM agents. CMS should also keep the existing "A" codes for LOCM for cost-tracking purposes. Mammography On December 8, 2003, President Bush signed into law Medicare reform legislation, which included language for mammography. This language states that, starting in 2005, the technical portion for diagnostic mammography will be paid at the Medicare Fee Schedule rate regardless of setting. In other words, there will no longer be an APC rate for diagnostic mammography performed in a hospital setting. The ACR would like CMS to disclose any foreseeable problems with the existing coding practices in hospitals that may arise from this mandate. This will allow the College to become aware of any potential management and administrative predicaments and react accordingly to alleviate any of the problems, if necessary. The ACR recommends that CMS educate hospitals on the recent mammography mandate and develop a system to instruct hospitals on how coding procedures should be changed in 2005 to accommodate this adjustment. Computed-Aided Detection (CAD) for Diagnostic Mammography APC 0140 (Mammography Add-on) The ACR remains concerned about CMS's decision to move computer-aided detection with mammography from new technology APC 0706 with payment rate of $25.00 to APC 0140 (mammography add-on) with a payment rate of $8.31. As stated in the ACR's comment letter on the 2004 HOPPS proposed rule, this represents a significant payment decrease that does not account for all the costs of the add-on procedure. Although CMS indicated that the reassignment of this code from a new technology APC to its own APC 0410 is appropriate given the amount of claims that were used to calculate the payment rate, the ACR continues to consider the amount of data claims still insufficient and inaccurate. CMS's data file shows that a total of 735,245 diagnostic film mammography procedures were reported, but only 39,095 diagnostic CAD procedures were used (approximately 5% of the film claims). As CAD is an add-on code, these values have to be called into questions and properly addressed. The ACR will, therefore, extend the recommendation to keep CAD in new technology APC until more claims can be used. The ACR would also ask that CMS look into the multiple claims that include mammography and CAD, performed in the same day, that are currently ignored given that only single claims can be used for reimbursement calculations. As mentioned in the previous heading, mammography reimbursement will rely on the Medicare fee schedule for physicians and will no longer be based on hospital claims data. Since the mammography item in these multiple claims (in which CAD is also included) will no longer be needed for mammography reimbursement in hospitals, the ACR recommends that CMS find a methodology to ignore the mammography items and thereby transform these multiple claims into single CAD claims. The ACR would like CMS to consider how it can clean this multiple claims data so that it can capture the costs of the add-on code 76085 for 2003 and 76082 and 76083 for 2004. This would allow CMS to use all these transformed single claims in the CAD median cost calculation and allow for truer representation of the cost. The ACR recommends that, in the meantime, CMS put the CAD codes back in the new technology APC. Alternatively, the ACR suggests that CMS interpret the legislation, which revises hospital-based diagnostic mammography APC rates, to allow linking the APC payment rate to the add-on codes for CAD to be equivalent to their payment rate under the Medicare Fee Schedule (which is currently approximately $18). The ACR appreciates any other option that can more appropriately account for the costs of these mammography add-on codes. CPT® 76082 and 76083 The two codes designated for CAD in 2004 that replaced the 2003 mammography add-on code (CPT® 76085) are CPT® 76082 (Computer mammography add-on, for diagnostic mammography) and 76083 (Computer mammography add-on, for screening mammography). The ACR assumes that since CPT® 76083 is not assigned an APC code or payment rate, it is paid, as is the screening mammography code CPT® 73092, under a non-HOPPS pool payment system. Since no detailed language on code 76083 payment arrangement was found on the CMS 2004 HOPPS final rule, the ACR requests that CMS clarify the payment system to which CPT® 76083 is paid under to confirm whether the College's assumption that the code is paid under a non-HOPPS pool system is in fact correct. If, however, the ACR's assumption is incorrect, the ACR recommends that CMS include code 76083 in the same APC as CPT® 76082 is assigned (APC 410), given that CPT© 76083 and 76082 require the same equipment and costs. APC Advisory Panel The ACR would like to request that CMS give as much notification as possible on the date and final agenda of the 2004 APC Advisory Panel meeting. It is difficult to arrange attendance of representatives, register with the national office, and prepare testimony without adequate advance notice. Summary The ACR appreciates the opportunity to provide comments regarding the 2004 Hospital Outpatient Prospective Payment System final rule and anticipates CMS's consideration of the issues discussed above. The ACR would like to emphasize the importance of CMS initiating a rigorous educational program for hospitals that would improve current coding practices, and provide clear and concise instructions on the new coding and cost reporting changes for 2004, including changes contained within recent legislation. In an effort to create an efficient payment system, this educational process would allow existing codes to be more efficiently and accurately reported, as well as allow hospitals to promptly establish accurate cost data reporting based on the new provisions set for 2004. The ACR is interested in CMS's interpretation of changes contained in the new Medicare legislation (H.R.1) and proposes that CMS work with the College and other specialty societies on a common understanding and implementation of new regulations. In addition, the ACR is currently reviewing the 2004 interim final rule released January 6, 2004, for future comments to CMS that pertain to radiology and radiation oncology. The ACR is available to discuss the above comments in further detail or answer any questions. Please contact Iara Woody or me by phone at (800) 277-5463, ext. 4335 or 4958 respectively, or via e-mail at pamelak@acr.org. or Iaraw@acr.org. Sincerely, Pamela J. Kassing Senior Director Economics and Health Policy American College of Radiology (ACR) cc: Tom Gustafson, CMS Cynthia Read, CMS Dana Burley, CMS William T. Thorwarth, M.D. John A. Patti, M.D. Ann Rosser Iara Woody Rachel Kramer