Comments on CMS-1632-P: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program

Dear Administrator Slavitt:

The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the referenced Centers for Medicare & Medicaid Services (CMS) fiscal year 2016 (FY 2016) proposed rule regarding payment rates and policies under the acute-care hospital inpatient prospective payment system (IPPS) and the long-term care hospital prospective payment system (LTCH PPS) (Proposed Rule).[1]  As the leading trade association representing medical imaging and radiopharmaceutical manufacturers, we have in-depth knowledge of the significant benefits of medical imaging to the health of Medicare beneficiaries.  MITA appreciates the opportunity to work with CMS on reimbursement and quality initiatives, including hospital initiatives, to encourage appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, treatment, and surveillance of many diseases.  Our comments are directed to the Proposed Rule’s impact on meaningful access to these technologies.

Medical imaging encompasses x-ray imaging, computed tomography (CT) scans, ultrasound, nuclear imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI).  Medical imaging is used to diagnose patients with a variety of medical conditions, often detecting morbidity earlier than would otherwise be possible, reducing the need for costly medical services and invasive surgical procedures, and improving patient outcomes.[2]  In addition, medical imaging equipment often is used to select, guide, and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.[3]

Our comments address ways to improve the accuracy and validity of cost-to-charge ratios (CCRs) used to calculate relative values and establish hospital payment rates, the importance of revising the Hospital-Acquired Condition (HAC) list to address reductions in iatrogenic pneumothorax with paracentesis and arterial puncture with thoracentesis, and our concerns with the proposed cost measures for the Hospital Inpatient Quality Reporting (IQR) and Value-Based Purchasing (VBP) Programs.

Summary of Comments

  1. CMS should work with stakeholders to update cost reporting instructions and improve the accuracy and validity of national average CCRs. Hospital reporting of nonstandard cost center codes continues to be inconsistent, and the methodology used by CMS to determine CCRs results in apparent inaccurate payment rates under the IPPS and LTCHS PPS.  MITA urges CMS to adopt policy changes to improve the accuracy of these CCRs, but still allow sufficient flexibility so that hospitals can make needed adjustments for new or unique procedures.  MITA also suggests that CMS refine its current approach, so that inaccurate CCRs are not used for any PPS rate, including the IPPS rates proposed for FY 2016 in the Proposed Rule.
  1. CMS should revise the HAC list to incentivize reductions in iatrogenic pneumothorax at the time of a thoracentesis and an arterial puncture at the time of paracentesis. MITA strongly urges CMS to expand the iatrogenic pneumothorax HAC, which currently addresses only iatrogenic pneumothorax with venous catheterization, to also include iatrogenic pneumothorax that occurs with thoracentesis and arterial puncture that occurs with paracentesis.  New evidence shows significant reduction in such events when ultrasound imaging is incorporated into hospital protocols.  Our recommended revisions would meet the three statutory conditions for the HAC reduction initiative and, importantly, would decrease the frequency of these preventable complications.
  1. CMS should not adopt the proposed episode-based payment measures in the IQR and VBP Programs. CMS proposes four new clinical, episode-based payment measures to focus on resource use efficiency and cost reduction.  MITA is concerned that a comparison of resource costs does not address the quality aims of the IQR and VBP Programs and recommends, to the extent such measures are adopted, that CMS incorporate the full range of factors outside of providers’ control that may affect the cost of care provided.

I. CMS Should Adopt Program Instructions to Improve the Accuracy and Validity of Hospital Cost Reporting and CMS Computation of CCRs

Under the IPPS and LTCHS PPS, a hospital generally receives a single payment for a case based on the payment classification code—MS-DRGs under the IPPS and MS-LTC-DRGs under the LTCH PPS—assigned at discharge.  As in the past two fiscal years, for FY 2016, CMS calculated proposed MS-DRG relative weights using two data sources: the MedPAR file as the claims data source and the Healthcare Cost Report Information System (“HCRIS”) as the cost report data source. In so doing, CMS applied nineteen national average cost-to-charge ratios (CCRs)—including, for example, radiology, MRIs, and CT scans CCRs—which are calculated from hospital cost reports.  MITA previously expressed concerns about the validity of certain CCR data and the effect that data errors may have on the accuracy of Medicare payments, particularly on payments for acute hospital inpatient and outpatient services.  In the proposed rule, CMS confirms MITA’s concerns by describing additional significant inconsistencies in the HCRIS data and by acknowledging that the current methods of calculating CCRs do not account for the inconsistencies.  MITA therefore urges the Agency to work with stakeholders to refine the current methodology and limit its use of CCRs that result in flawed rate-setting.

CMS states in the Proposed Rule that before calculating the nineteen national average CCRs for FY 2016, the Agency reviewed the HCRIS data on which it relies to calculate the CCRs and found potentially material inconsistencies.  Specifically, CMS “discovered that hospitals typically report . . . nonstandard codes with standard cost centers that are different from the standard cost centers to which CMS maps and ‘rolls up’ each nonstandard code in compiling the HCRIS.”[4]  CMS explained that when it moves costs from various nonstandard cost centers to standard cost centers, the Agency relies on the nonstandard cost center code numbers, not on the cost center descriptions used by hospitals.  As CMS has discovered, the roll-up process it uses may not accurately reflect the services that hospitals actually provided.

MITA appreciates CMS’s acknowledgement of a problem arising from many hospitals’ use of nonstandard cost center codes.  This issue was brought to CMS more than seven years ago by RTI International, which was retained by the Agency to assess how CCRs could be refined for calculating Ambulatory Payment Classification Groups (APC) and DRG relative payment weights.[5]  In evaluating HCRIS data, RTI first identified what appeared to be an unusual number of hospitals reporting nonstandard costs and charges on a line identified as “Acupuncture.”  Because acupuncture is not covered by Medicare, RTI broadened reviews to other nonstandard cost centers.  On further review, RTI noted that the prevalence of the use of the acupuncture nonstandard cost center was simply that it was the first choice in an alphabetic list of codes.  RTI determined that nonstandard cost centers frequently reflected misclassifications and there was no feedback to preparers to alert them of a mismatch between the nonstandard and appropriate cost code.  The consultant noted that not only do these “misclassifications defeat the purpose of the supplemental HCRIS codes,” but also they “create potential for distortion in all CCRs.”[6]

Additionally, RTI found the impact of hospital reporting errors to be significant.  Whereas RTI acknowledged that line reassignments may have less impact on MS-DRG weights because CCRs are already highly aggregated and are based on national average ratios, the consultant observed that APC median costs may be altered by changing service-specific provider-level CCRs, among other changes.  Indeed, when RTI reassigned misclassified HCRIS cost codes in its sample, it found that the number of hospitals reporting separate cost centers for CT scans increased by 25 percent, MRI by 28 percent, Ultrasound by 23 percent and Cardiac Catheterization by 27 percent.  In addition, RTI’s reassignments reduced charges assigned to the standard line for Diagnostic Radiology by 5 percent and increased charges assigned to CT Scanning and to MRI by 27 percent each, and to Cardiac Catheterization by 32 percent.  The area with the most significant change was Oncology, with an increase of 253 percent.

According to CMS’s own observations, certain CCRs it calculated for FY 2016, including the Radiology and “Other Services” CCRs, are affected by the observed inconsistencies in cost reporting.  The CMS-proposed FY 2016 Radiology CCR is 0.159.  CMS notes that were the Agency to roll up all radiology-related nonstandard codes to standard line 76, “Other Ancillary,” where hospitals placed them, and not to standard lines 54 (Radiology-Diagnostic), 55 (Radiology- Therapeutic), and 56 (Radioisotope) under CMS’s usual practice, the Radiology CCR would be higher, at 0.161.  According to CMS, most affected is the proposed FY 2016 “Other Services” CCR, which CMS calculates at 0.367.  If all nonstandard cost center codes were to remain in line 76, “Other Ancillary,” as hospitals have reported them in their FY 2013 cost reports, instead of CMS applying its usual practice of rolling up these lines to the applicable “Electrocardiology” and “Radiology” standard cost centers, among others, the “Other Services” CCR would be 0.291.[7]

MITA is concerned that the differences between hospitals’ use of nonstandard cost center codes and CMS’s procedures for mapping and rolling up nonstandard codes to the standard cost centers will continue to result in invalid CCRs and inaccurate payments.  This also compounds the problems MITA raised in earlier comment letters regarding allocation of capital costs and the new CCRs for MRIs and CT scans.  The Agency does not appear to suggest making changes to its calculations for FY 2016, but it is clear that if CMS continues to apply the current rollup procedures of mapping all nonstandard codes to specific standard cost centers (as compared to following hospitals’ general practices, which are found to be inconsistent both with the CMS methodology and with each other), at least some of the CCRs used to determine MS-DRG weights will be affected.

MITA urges CMS to change current procedures for reporting nonstandard cost center codes in consultation with stakeholders.  MITA also recommends that CMS revise the Agency’s current instructions to hospitals in a timely way, so that any procedures for mapping and rolling up nonstandard codes to specific cost centers are both accurate and uniformly applied.

CMS’s proposal appears to be a viable one:

[Allowing] only certain nonstandard codes to be used with certain standard cost centers, meaning that CMS might require that the CMS-approved cost reporting softwares “lock in” those nonstandard codes with their assigned standard cost centers. For example, if a hospital wishes to subscript a standard cost center, the cost reporting software might allow the hospital to choose only from a predetermined set of nonstandard codes.  Therefore, for example, if a hospital wished to report Cardiopulmonary costs and charges on its cost report, the only place that the hospital could do that under this approach would be from a drop down list of cardiology-related services on standard line 69, ‘Electrocardiology,’ and not on another line (not even line 76, ‘Other Ancillary’).[8]

If CMS adopts this proposal, MITA recommends that hospitals be given sufficient advance notice to adjust their current cost reporting approach.  Lack of familiarity with any new cost reporting instructions and format may generate other, unanticipated cost reporting errors.  MITA also stresses the need for flexibility in a cost-reporting process, to accommodate any new or unique services that certain hospitals may provide, which may not be easily captured through the cost reporting software described above.

Finally, as MITA has explained in comments to prior IPPS and LTCH-PPS rules, CMS should pay particular attention to data used for CT and MRI cost centers; the hospital payment rates established by CMS from the CT scan and MRI CCRs simply do not correlate with resources used for these capital-intensive services.  In short, CMS’s procedures for rolling up nonstandard codes to specific standard cost centers may further exacerbate validity issues with the CT scan, MRI and other CCRs.

II. CMS Should Refine the HAC List to Include Iatrogenic Pneumothorax with Paracentesis and Thoracentesis

In its Proposed Rule, CMS does not propose to add or remove any current categories of HACs, but affirms that it “will continue to monitor contemporary evidence-based guidelines for selected, candidate, and previously considered HACs that provide specific recommendations for the prevention of the corresponding conditions in the acute hospital setting and may use this information to inform future rulemaking.”[9]  CMS also continues “to encourage public dialogue about refinements to the HAC list through written stakeholder comments.”[10]  MITA urges CMS to consider at this time areas of patient safety where appropriate use of efficient imaging procedures would have a positive impact on patient care by eliminating certain complications.

CMS has indicated in prior rulemaking that the Agency would consider whether iatrogenic pneumothorax with thoracentesis and accidental puncture/bleeding with paracentesis meet the criteria for inclusion in the HAC program.[11]  MITA strongly believes the current iatrogenic pneumothorax with venous catheterization measure should be expanded to address these two conditions.  Both of these conditions satisfy the three-prong test established by the Medicare statute for selection as a HAC.

First, these conditions are high volume, high cost, or both.  Studies show that pneumothorax occurs in 2 to 30 percent of diagnostic thoracentesis, with 15 to 50 percent of these patients requiring tube thoracostomy.[12]  A systematic review and meta-analysis found that for 24 studies that reported pneumothorax rates following 6,055 thoracentesis procedures, the overall rate of pneumothorax was 6.0 %.[13]  One-third of these complications required placement of a chest tube.[14]

Iatrogenic pneumothorax also imposes high costs for patients, providers, and payors.  A 2013 study showed that the complication of a collapsed lung raised a patient’s hospital costs to $13,784 compared to $11,032 without this complication. [15]  Similar cost and complication reductions were identified in an earlier study.[16]

Complications resulting from arterial punctures occurring at the time of a paracentesis likewise can have significant effects on morbidity and mortality, and care required to correct these hemorrhage and perforation medical errors is very costly.[17]  Using the Premier Hospital Database, the United Biosource Corporation conducted a study where bleeding complications following a paracentesis were analyzed.  This study, which is cited in the Journal of Patient Safety, found that these bleeding events increased the total average cost of hospitalization by $19,066 per patient stay and the average length of stay by 4.3 days.[18]

Second, these conditions result in assignment of a case to an MS-DRG that has a higher payment when they are present as a secondary diagnosis.  A thoracentesis may be assigned one of six ICD-10-PSC procedure codes.[19]  The condition of iatrogenic pneumothorax is currently coded using ICD-9-CM diagnosis code 512.1.  Under ICD-10-CM, it will be coded as J95.811, which is recognized as a complication and comorbidity under the IPPS.  Paracentesis may be described by as many as fifteen ICD-10-PSC procedure codes.[20]  The arterial puncture condition is currently coded using ICD-9-CM diagnosis codes 568.81, and in ICD-10-CM will be coded as K66.1, D78.01, D78.02, D78.21, K91.61, K91.62,  K91.840, or K91,841, each of which is recognized as a complication and comorbidity under the IPPS.

Third, these conditions could reasonably be prevented through application of evidence-based guidelines.  The practice of using ultrasound guidance to reduce the complication of iatrogenic pneumothorax at the time of a paracentesis or a thoracentesis has been studied for many years and is supported by many studies.  Hospitals using ultrasound guidance when performing a thoracentesis have been able to reduce the complication of iatrogenic pneumothorax significantly.  A 2005 article addresses sonographically guided thoracentesis resulting in lower rates of pneumothorax (4.9% vs. 10.3%; p<.05) and reduced use of tube thoracostomy (.7% vs. 4.1%; p<.05) when compared with thoracenteses performed without the benefit of ultrasound guidance.[21]  In a prospective, randomized clinical trial, emergency medicine physicians successfully performed paracentesis in 95% of patients under ultrasound guidance.[22]  Only 61% of patients were successfully managed using the traditional technique.[23]

The use of ultrasound to guide a paracentesis or a thoracentesis is endorsed by the American College of Chest Physicians (ACCP), the American Board of Internal Medicine (ABIM), the Accreditation Council for Graduate Medical Education (ACGME) and the American College of Emergency Physicians (ACEP).  The ACCP issued an evidence-based consensus statement in 2009 regarding the need for their members to be competent in ultrasound procedures of the pleura to allow for ultrasound guidance of thoracentesis procedures in the critically ill.[24] Effective July 1, 2012 the ACGME program requirements in pulmonary disease and critical care medicine required demonstrated clinical competency in the use of ultrasound techniques to perform a thoracentesis and placement of intravascular and intracavitary tubes and catheters.[25]  These requirements are also endorsed by the ABIM.[26]  In their criteria compendium for emergency ultrasound imaging, the ACEP also endorses use of procedural ultrasound to evaluate for pleural effusion and/or drain pleural effusion with ultrasound guidance or localization (thoracentesis).[27]  In light of safety data regarding the use of ultrasound guidance to prevent complications from iatrogenic pneumothorax and arterial puncture, the United Kingdom’s National Institute for Health and Clinical Excellence established guidelines that recommend ultrasound guidance as the preferred method to lower the risk for these complications.[28]

MITA believes that adding thoracentesis to activities where an iatrogenic pneumothorax is a likely complication and arterial puncture at the time of paracentesis, would decrease the frequency of these complications.  Not only would this lead to better patient care, but also this would translate to cost savings to the Medicare system.

III. CMS Should Refine Proposed Episode-based Payment Measures in the IQR and VBP Programs to Adequately Consider Quality of Care.

MITA previously submitted comments expressing concerns with measures such as the Medicare spending per beneficiary (MSPB) under the IQR and VBP programs because such measures assess only the volume of spending during episodes of care without adequately considering the quality or appropriateness of the care provided.  Specifically, measures focusing only on the cost of care may inadvertently create incentives for hospitals to reduce utilization of appropriate and necessary diagnostic technologies and therapeutic options.  MITA believes these concerns also apply to the four new clinical episode-based payment measures that CMS proposes to include in the Hospital IQR program beginning with the FY 2018 payment determination.[29]

Like the MSPB measure, the four new clinical episode-payment measures assess the cost of services initiated during an episode of care spanning from 3 days prior to an inpatient hospital admission through 30 days post-hospital discharge.  Unlike the MSPB measure, the clinical episode-based measures include only Medicare Part A and Part B services that are clinically related to the triggering diagnosis or procedure.  According to CMS, the measures are meant to “allow[] meaningful comparisons between providers based on resource use for certain clinical conditions or procedures.”[30]  CMS selected the four new clinical episode-based payment measures in part due to their high costs with substantial variation.  MITA is concerned that the CMS approach minimizes the emphasis on quality in the statutory authorization for IQR measures.[31]

As CMS acknowledges, treatment and costs may vary depending on patient characteristics.  Treatment decisions may also vary based on clinician judgment, experience levels and patient preferences.  While the clinical episode-payment measures are risk-adjusted for variance in patient characteristics that are expected to affect costs, they do not appear to take into account other factors that may also affect care provided and associated costs.

The proposed Lumbar Spine Fusion/Refusion Clinical Episode-Based Payment Measure provides some insights as to inherent flaws in designing measures with incentives to reduce clinically related post-discharge costs.  CMS describes “substantial variation in spinal fusion/refusion episode costs—ranging from approximately $28,000 at the 5th percentile to approximately $60,000 at the 95th—that is driven by variation in post-discharge costs clinically related to the inpatient hospitalization.”[32]  This variation, however, may also reflect factors that are outside of providers’ control, such as sociodemographic factors or the quality of post-discharge care to which a patient has access.[33]

In addition, attempting to reduce the cost of care through clinical episode-based payment measures may introduce incentives that reduce the use of more appropriate care.  The mere selection of the Lumbar Spine Fusion/Refusion Clinical Episode-Based Payment Measure, for instance, may influence providers to avoid certain imaging procedures needed to diagnose, establish appropriate radiographic documentation of spinal instability and/or confirm the effectiveness of treatment.  The measure would incentivize the lowering of costs, but would not necessarily reflect best clinical practices.[34]  In sum, by not accounting for all variables influencing the costs of resources, and by not including measures of quality and appropriateness directly related to the clinical episode, CMS risks divorcing quality of care from efficiency of care through the proposed clinical episode-based payment measures.  MITA urges CMS to delay adoption of the proposed clinical-episode payment measures until such time as they incorporate a full range of factors outside of providers’ control that may affect the cost of care provided and incorporate quality and appropriateness measures that are directly related to the clinical episode.  Doing so will provide meaningful measure so that hospitals evaluate the necessity of the services they provide to Medicare beneficiaries without discouraging appropriate care solely because of its cost.

*          *          *          *

MITA appreciates this opportunity to comment on the FY 2016 IPPS Proposed Rule.  We would be pleased to discuss or answer any questions you might have about these comments.  Please contact me at (703) 841-3238 if MITA can be of any assistance.


Peter M. Weems

Director of Policy, MITA

[1] 80 Fed. Reg. 24,324 (Apr. 30, 2015).

[2] See, e.g., Hughes, et al., “Perspectives on the Value of Advanced Medical Imaging: A National Survey of Primary Care Physicians,” Journal of the American College of Radiology, 12 (2015): 458-462; Goldstein, et al., “The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial,” Journal of the American College of Cardiology 2011; 58 (14): 1414-1422; Perrier, et al., “Multidetector-Row Computed Tomography in Suspected Pulmonary Embolism,” New England Journal of Medicine, 2005; 352: 1760-1768.

[3] See, e.g., Sibbitt, et al., “A Randomized Controlled Trial of the Cost-Effectiveness of Ultrasound-Guided Intraarticular Injection of Inflammatory Arthritis,” Journal of Rheumatology 2011; 38 (2): 252-263; Jelinek, JS et al., “Diagnosis of Primary Bone Tumors with Image-Guided Percutaneous Biopsy: Experience with 110 Tumors,” Radiology, 2002; 223 (3): 731-737.

[4] Proposed Rule, 80 Fed. Reg. 24,324, 24,344 (Apr. 30, 2015).

[5] See RTI International, “Refining Cost to Charge Ratios for Calculating APC and MS-DRG Relative Payment Weights,” Final Report, July 2008, pp. 25-40.

[6] Id. at 30.

[7] Id. 

[8] 80 Fed. Reg at 24,346.

[9] Id. at 24,348.

[10] Id. 

[11] 79 Fed. Reg. 49,854, 49,879 (Aug. 22, 2014).

[12] Barnes, et al., “Sonographically Guided Thoracentesis and Rate of Pneumothorax,” Journal of Clinical Ultrasound, 2005 Dec; 33(9):442-446.

[13] Gordon CE, et al., “Pneumothorax Following Thoracentesis: A Systematic Review and Meta-Analysis,” Archives of Internal Medicine, 2010 Feb;170(4): 332-339.

[14] Id. 

[15] Mercaldi CJ, et al., “Ultrasound Guidance Decreases Complications and Improves the Cost of Care Among Patients Undergoing Thoracentesis and Paracentesis,” Chest, 2013 Feb 1;143(2): 532-538.

[16] Patel PA, et al., “Ultrasonography Guidance Reduces Complications and Costs Associated with Thoracentesis Procedures,” Journal of Clinical Ultrasound, 2012 Mar-Apr; 40(3): 135-141.

[17] Peabody CR, et al., “Deep Needle Procedures: Improving Safety With Ultrasound Visualization,” Journal of Patient Safety, 2014 Aug 12; doi: 10.1097/PTS.0000000000000110,

[18] Id.

[19] These codes include:
0B9N30Z Drainage of Right Pleura with Drainage Device, Percutaneous Approach;
0B9N3ZX Drainage of Right Pleura, Percutaneous Approach, Diagnostic;
0B9N3ZZ Drainage of Right Pleura, Percutaneous Approach;
0B9P30Z Drainage of Left Pleura with Drainage Device, Percutaneous Approach;
0B9P3ZX Drainage of Left Pleura, Percutaneous Approach, Diagnostic, and;
0B9P3ZZ Drainage of Left Pleura, Percutaneous Approach.

[20] These codes include:
0D9S30Z Drainage of Greater Omentum with Drainage Device, Percutaneous Approach;
0D9S3ZZ Drainage of Greater Omentum, Percutaneous Approach;
0D9T30Z Drainage of Lesser Omentum with Drainage Device, Percutaneous Approach;
0D9T3ZZ Drainage of Lesser Omentum, Percutaneous Approach;
0D9V30Z Drainage of Mesentery with Drainage Device, Percutaneous Approach;
0D9V3ZZ Drainage of Mesentery, Percutaneous Approach;
0D9W30Z Drainage of Peritoneum with Drainage Device, Percutaneous Approach;
0D9W3ZZ Drainage of Peritoneum, Percutaneous Approach;
0W9F30Z Drainage of Abdominal Wall with Drainage Device, Percutaneous Approach;
0W9F3ZZ Drainage of Abdominal Wall, Percutaneous Approach;
0W9F4ZZ Drainage of Abdominal Wall, Percutaneous Endoscopic Approach;
0W9G30Z Drainage of Peritoneal Cavity with Drainage Device, Percutaneous Approach;
0W9G3ZZ Drainage of Peritoneal Cavity, Percutaneous Approach;
0W9J30Z Drainage of Pelvic Cavity with Drainage Device, Percutaneous Approach, and;
0W9J3ZZ Drainage of Pelvic Cavity, Percutaneous Approach.

[21] Barnes, et al., “Sonographically Guided Thoracentesis and Rate of Pneumothorax,” Journal of Clinical Ultrasound, 2005 Dec; 33(9): 442-446.

[22] Nazeer SR, et al., “Ultrasound-Assisted Paracentesis Performed by Emergency Physicians vs. the Traditional Technique,” American Journal of Emergency Medicine, 2005; 23, 363–367.

[23] Id.

[24] Mayo, et al., “American College of Chest Physicians/La Societe de Reanimation de Langue Francaise Statement on Competence in Critical Care Ultrasonography,” Chest, 2009;135; 1050-1060.

[25] ACGME Program Requirements for Graduate Medical Education in Pulmonary Disease and Critical Care Medicine (Internal Medicine), eff. July 1, 2012,

[26] ABIM Policies and Procedures for Certification, at 7, Feb. 2015,

[27] ACEP Policy Statement: Emergency Ultrasound Imaging Criteria Compendium, at 31 (approved April 2006),

[28] National Institute for Health and Clinical Excellence, Guidance on the Use of Ultrasound Locating Devices for Placing Central Venous Catheters (2002),

[29] These new measures include: “[t]he Kidney/Urinary Tract Infection Clinical Episode-Based Payment measure, the Cellulitis Clinical Episode-Based Payment measure, the Gastrointestinal Hemorrhage Clinical Episode-Based Payment measure, and the Lumbar Spine Fusion/Refusion Clinical Episode-Based Payment measure.”  Proposed Rule, 83 Fed. Reg. at 24,567.

[30] Proposed Rule, 83 Fed. Reg. at 24,567.

[31] See 42 U.S.C. § 13955ww(b)(3)(B)(viii)(III) (“The Secretary shall expand . . . the set of measures that the Secretary determines to be appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in inpatient settings.”).

[32] Proposed Rule, 83 Fed. Reg. at 24,571.

[33] The National Quality Forum (NQF) notes in its final report on episode based performance measurement, funded by the Department of Health and Human Services, that “[t]he issue of addressing sociodemographic factors, particularly when measuring resource use among certain populations is a vital one.” NQF, Episode Grouper Evaluation Criteria (Sept. 5, 2014), at p. 15.

[34] See 42 U.S.C. § 13955ww(b)(3)(B)(vii)(VI) (establishing that “the Secretary may replace any measures or indicators in appropriate cases, such as where . . . the measures or indicators have been subsequently shown not to represent the best clinical practice”); see also 74 Fed. Reg. 43,862 (Aug. 27, 2009) (noting that “the Secretary is granted broad discretion to replace measures that are no longer appropriate for the [IQR] program”).