June 25, Dear Acting Administrator Tavenner,

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1 June 25, 2012 Marilyn B. Tavenner, RN, Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1588-P P.O. Box 8011 Baltimore, MD Re: Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2013 Rates and to the Long Term Care Hospital PPS and FY 2013 Rate (File Code: CMS P) Dear Acting Administrator Tavenner, The Infectious Diseases Society of America (IDSA) appreciates the opportunity to provide comments on the FY 2013 Inpatient Prospective Payment System (IPPS) proposed rule. IDSA represents more than 9,800 infectious diseases physicians and scientists devoted to patient care, prevention, public health, education, and research in the area of infectious diseases (ID). The Society's members focus on the epidemiology, diagnosis, investigation, prevention and treatment of infectious diseases in the United States and abroad. Our members care for patients of all ages with serious infections, including meningitis, pneumonia, tuberculosis, surgical infections, those with cancer or transplants who have life-threatening infections caused by unusual or drug-resistant microorganisms, people living with HIV and AIDS, and new and emerging infections, such as severe acute respiratory syndrome (SARS) and H1N1 influenza. IDSA members are committed to improving the quality and safety of patient care in hospitals and health systems across the nation. ID specialists work in collaboration with other healthcare personnel to develop and implement evidence-based practices to prevent and control health care-associated infections (HAIs). IDSA believes that policy decisions which align with evidence-based practices are the best approach for preventing HAIs and protecting patients and communities. Since HAIs and their measured improvement figure prominently in CMS quality and reimbursement programs, our comments focus primarily on the Value-Based Purchasing (VBP) Program, the Inpatient Quality Reporting (IQR) Program, and the Hospital-Acquired Condition Payment Policy.

2 Inpatient Value-Based Purchasing Program The 2013 proposed IPPS rule continues to implement elements of the Hospital Inpatient Value- Based Purchasing Program (VBP) which will vary payments to hospitals based on performance measures starting in FY The proposed rule lays out operational details for the first year of the VBP Program, including a review and corrections process that would allow hospitals to correct their performance data before it is publicly posted on the Hospital Compare website, and an administrative appeals process that would give hospitals an opportunity to appeal the calculation of the performance assessment component of their total performance score. The IDSA supports the inclusion of mechanisms that give hospitals the opportunity to review and correct performance data before it is publicly reported, as well as opportunities to appeal calculations. This is especially critical due to the complicated nature of scoring and riskadjusting performance data, the significant financial incentives attached to the program, and the budget-neutral manner in which payments will be distributed. We further appreciate CMS proposal to offer data review and appeal opportunities given the fact that the Hospital VBP Program will likely set the foundation for the forthcoming Physician VBP Program. Therefore, it is important that CMS continue to carefully monitor and evaluate the hospital program for unexpected challenges-- such as attribution-- and unintended consequences-- such as avoidance of complicated cases to increase a facility s performance score-- and apply any lessons learned to the physician program. In terms of specific measures that hospitals would be held accountable for under the VBP Program, CMS proposes for 2015 to add a Patient Safety Indicator (PSI-90) composite outcome measure, which looks at rates of multiple serious complications including central venous catheter-related bloodstream infections and postoperative sepsis. While IDSA fully supports efforts to minimize unnecessary complications and infections, this composite measure, which is already being reported under the Hospital Inpatient Quality Reporting (IQR) Program, has been widely criticized for not being appropriately risk-adjusted and for relying on inadequately validated administrative data that do not allow for proper comparisons between patients of varying levels of severity. Thus, the measure tends to exaggerate problems at hospitals that treat more complicated cases or see sicker patients. Furthermore, the indicators, which were originally developed by the Agency for Healthcare Research and Quality (AHRQ), were never intended to compare hospitals. Instead, they were developed to help hospitals flag events to apply internal quality improvement effort. In January, a National Quality Forum (NQF) committee recommended against using this patient safety composite measure (PSI-90) for payment purposes due to concerns about the reliability of the data sources. We recommend that CMS not link hospital payments to performance on this composite measure until these issues are resolved. CMS also proposes to use for 2015 an efficiency measure titled, Medicare Spending per Beneficiary, which evaluates the amount Medicare spends on an average hospital beneficiary during an episode that includes the inpatient stay, three days preceding it, and 30 days following the stay. The IDSA supports efforts to target inappropriate or excessive spending in health care. However, we urge CMS to move carefully with implementation of this measure, as it represents the very first time that payments to hospitals would vary according to efficiency of services

3 when many aspects of efficiency measurement are still not understood. For example, it is still unclear how cost variances equate with patient outcomes, such as infection rates and mortality. How do we know that patients at a low-cost hospital are able to access all of the services they truly need? From our own analysis of the Medicare claims data, we know that there are circumstances where patients with known severe infectious conditions do not receive a consult by an infectious diseases specialist for reasons unknown, while other similar patients (riskadjusted) in the very same hospitals do receive an ID consult. 1 Furthermore, we know not all hospitals have ID specialists on their medical staff. While the measure in principle may have merit, it relies on claims data, a system that was developed primarily for billing and reimbursement purposes and does not always accurately capture every factor influencing clinical decisions. This measure also has not been tested, cannot necessarily be replicated, and has still not received the endorsement of the National Quality Forum. Furthermore, there continues to be a lack of national data that hospitals can use to verify CMS calculations, determine the appropriateness of the methodology and analyze true differences in performance since the downloadable file of data currently available to the public on the Hospital Compare website does not contain all the detail one would need to effectively understand the details of this measure. The Medicare Spending per Beneficiary measure evaluates not only a hospital s own costs of providing care to patients, but also all Medicare Part A and Part B costs associated with care post-discharge, including physician follow-up visits and long term care costs. As such, physicians may be pressured by hospitals to keep costs down due to this measure, especially since CMS proposes to use this measure for a significant proportion 20% of a hospital's value-based purchasing score to determine incentive payments for discharges starting Oct. 1, While we appreciate CMS decision to delay the start date of the initial performance period for this measure from May 2012 to May 2013 so that it could be publicly reported for a year prior to it being tied to payment, we feel that even this revised date may be premature. The IDSA strongly recommends that CMS refrain from tying this measure to payment until it is further tested and until CMS has established that it reliably indicates better patient care. Furthermore, CMS also expresses concern about the fact that policies governing the Hospital VBP Program have been released as part of both the inpatient and outpatient hospital payment rules. To streamline this process, CMS proposes to modify performance standards and performance periods using a sub-regulatory process. It is unclear if this process will allow for public comment before implementation. The IDSA supports full transparency and feels that the general public-- especially those directly affected by these measures and payment adjustments should be given a fair opportunity to provide input on performance standards and reporting periods prior to widespread implementation. Inpatient Quality Reporting Program The 2013 IPPS proposed rule would also expand the Inpatient Quality Reporting (IQR) Program, under which hospitals must publicly report measures on CMS s Hospital Compare Website to avoid a pay cut each year. In an attempt to reduce the reporting burden on hospitals and create a more streamlined measure set, CMS proposes to reduce the number of measures in the IQR program for both the FY 2015 and FY 2016 payment determinations. However, NQF has re- 1 Data on file. Infectious Diseases Society of America.

4 specified the CLABSI and CAUTI measures, which were originally limited to ICU cases, to now include non-icu hospital locations and other care settings. Despite this expansion, CMS proposes that the IQR Program would continue to require that hospitals submit data for these two measures on ICU locations only. As the proposed rule states, CMS intends to propose collection of data on these measures in non-icu locations in the future. The IDSA appreciates CMS efforts to streamline the IQR Program in an effort to reduce reporting burden and to minimize confusion among the public. We are concerned that the expansion of CLABSI and CAUTI measures to non-icu locations may, in reality, increase the overall reporting burden to institutions. We contend that, while the number of measures required for reporting may be reduced, an expansion in the sites where those measures apply may require additional resources to meet program compliance. Therefore, we urge CMS to allow ample time for institutions to expand data collection capabilities to non-icu hospital locations. We support CMS s continued use of the IQR, a pay-for-reporting program, to test the feasibility of reporting measures and to evaluate whether measures actually result in improved patient outcomes prior to including them in a pay-for-performance program. Hospital-Acquired Condition Payment Policy The Hospital-Acquired Condition (HAC) payment policy adjusts hospital payments for HACs that are high-cost, high-volume or both and could have been prevented through evidence-based measures. The program, mandated under the Deficit Reduction Act of 2005, prevents hospitals from being paid at the higher MS-DRG rate for patients with complications or major complications if the sole reason for the higher payment is the occurrence, during the beneficiary s hospital stay, of one of the conditions on the HAC list. In conjunction with the CDC, CMS proposes to expand the list of conditions subject to the HAC payment policy for FY 2013 to include the following: Surgical Site Infection Following Cardiac Implantable Electronic Device (CIED) Iatrogenic Pneumothorax with Venous Catheterization The IDSA was a partner in the development of HHS Healthcare-Acquired Infections Action Plan and agrees that preventable HACs persist as a major quality and cost of care problem. We are encouraged by CMS effort to integrate HAI measures across all HHS agencies, including the CDC. However, we remain concerned about the HAC payment policy s all-or-nothing approach, which still does not include adequate case-mix adjustments or provide a mechanism to flag cases where an infection occurred despite adherence to evidence-based guidelines. For many conditions on the HAC list, occurrence rates cannot be reduced to zero or near zero even when the evidence-based guidelines are followed. Some medical conditions, such as a compromised immune system, simply put patients at higher risk of a HAC than other medical conditions. While IDSA fully supports efforts to minimize HACs, it is inappropriate for CMS to deny payment for such complications without taking into consideration whether a patient did, in fact, receive optimal evidence-based care. We strongly encourage CMS to more carefully evaluate this program and its potential for unintended consequences and to explore how

5 information learned from present-on-admission coding could be used to better understand and prevent HACs before it considers the inclusion of any additional categories of HACs. Hospital Readmissions Reduction Program The 2013 proposed rule sets forth a methodology to account for a hospital s excess readmissions ratio by proposing to use a readmissions adjustment factor, or the ratio of a hospital's aggregate dollars for excess readmissions to the hospital's aggregate dollars for all discharges. This adjustment is estimated to result in a 0.3% Medicare payment decrease for hospitals or about $300 million. Payments to hospitals can be reduced by as much as 1.0%. While CMS notes that 481 hospitals would receive the full 1.0% payment adjustment under this proposal, the majority would have reductions of modest amounts (< 1.0%). While IDSA supports the intent of the Hospital Readmissions Reduction Program, we question the validity of the program. For one, the emphasis on 30-day readmissions is misguided since only a small proportion of readmissions at 30 days are truly preventable and much of what drives hospital readmission rates are patient- and community-level factors that are outside the hospital's control. Furthermore, it is unclear whether readmissions always reflect poor quality. High readmission rates also could be the result of low mortality rates or good access to hospital care. Recent research even has shown that higher readmission rates occur in communities with more physicians and hospital beds and in areas with high poverty and large minority or older populations. 2 Finally, we are concerned that the program may cause hospitals to forgo more urgent quality improvement efforts, such as those related to patient safety, as they focus a disproportionate amount of their resources on reducing readmissions. IDSA requests that CMS take these findings into account as it continues to develop a financing mechanism to discourage readmissions. If the current policy is applied uniformly across hospitals, it will likely penalize hospitals serving a high proportion of sick, poor, or minority patients. Efforts to target readmissions should be adequately risk-adjusted, and also account for the community in which hospitals operate, and engage healthcare professionals and caregivers outside of the hospital. Long-Term Care Hospital (LTCH) Quality Reporting Program CMS also proposes to add four additional measures, related to vaccinations and Ventilatorassociated Pneumonia (VAP), to the LTCH quality reporting program for the FY 2016 payment determination, including: Percent of Nursing Home Residents Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short-Stay) (NQF #0680); and Percent of Residents Assessed and Appropriately Given the Pneumococcal Vaccine (Short- Stay) (NQF #0682) 2 Joynt KE, Orav E, Jha AK. Thirty-day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7): doi: /jama

6 Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431) Ventilator Bundle (NQF #0302) The IDSA greatly appreciates CMS proposing to add measures that would ensure appropriate vaccinations among a relatively vulnerable population. Influenza and pneumococcal disease are especially prevalent among the elderly and although these measures have been endorsed by the NQF for short-stay nursing home residents only, these measures also are relevant to patients in the LTCH setting. The measure evaluating whether healthcare personnel received the influenza vaccine has previously been adopted for use in the IQR Program and the Ambulatory Surgical Center (ASC) quality reporting program. IDSA is pleased to see it being extended to the LTCH setting and for CMS proposing that it be reported through the CDC s NHSN. Furthermore, the ventilator bundle measure, which is NQF endorsed for ICU patients in the acute care setting, is proposed by CMS for addition to the LTCH quality reporting program under the authority for selecting non-nqf measures. We appreciate CMS recognition of ventilator-associated pneumonia as a costly, deadly infection that is highly prevalent in LTCHs. IDSA applauds the efforts of CMS to promote improved patient safety and better quality of care in inpatient hospital settings, while also aiming to reduce any unnecessary reporting burdens and achieve operational efficiency. We encourage CMS to roll out each of these programs in a stepwise manner that first carefully evaluates the effect on patient care and on clinical practice prior to widespread implementation. We welcome further discussion with CMS and other stakeholders on how to implement the recommendations detailed above. If you have any questions, please feel free to contact Andres Rodriguez, Senior Program Officer for Practice & Payment Policy, at or arodriguez@idsociety.org. Sincerely, Thomas G. Slama, M.D. President