THE SOCIETY OF THORACIC SURGEONS 633 NORTH SAINT CLAIR STREET, SUITE 2320 CHICAGO, ILLINOIS 60611-3658 Phone: 312.202.5800 Fax: 312.202.5801 E-mail: [email protected] Web: http://www.sts.org

June 25, 2012 Marilyn Tavenner Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: CMS-1588-P – Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals’ Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers Dear Acting Administrator Tavenner: On behalf of The Society of Thoracic Surgeons (STS), the largest organization representing cardiothoracic surgeons in the United States and the world, I am writing to provide comments on the FY 2013 Hospital Inpatient Prospective Payment Systems (IPPS) proposed rule. STS represents surgeons who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. As the largest specialty society representing cardiothoracic surgeons, we know that the vast majority of these lifesaving cardiothoracic procedures take place in the hospital setting. Therefore, the proposed changes in hospital payment, quality measurement, and other areas of policy could have profound effects on the way cardiothoracic surgeons deliver care to their patients. As you know, STS has a wealth of experience in measuring and improving patient quality of care, and continues to identify ways to reduce costs to the Medicare program through quality improvement. We appreciate the opportunity to share our comments. Specifically, STS would like to provide comments on the following areas: • • • • •

Proposed FY 2013 Medicare Severity Diagnosis-Related Group (MS-DRG) Documentation and Coding Adjustment Preventable Hospital-Acquired Conditions (HACs), Including Infections Items Related to International Classification of Diseases, Tenth Revision (ICD-10) Conversion Hospital Inpatient Quality Reporting (IQR) Program Indirect Medical Education (IME) Adjustment

June 25, 2012 CMS Acting Administrator Tavenner Page 2 Comments Section II. D. Proposed FY 2013 MS-DRG Documentation and Coding Adjustment CMS is required by statute to apply a documentation and coding adjustment in the calculation for the hospital case mix index (CMI). Concerns have been raised by stakeholders over the methodology CMS has used for determining the magnitude of excess of documentation and coding change on CMI in previous years. Specifically, the CMS’ methodology has been criticized for failing to separate documentation and coding effects from true case mix change. The STS agrees and urges CMS to use clinical data to distinguish documentation and coding changes from real case mix changes. Such an analysis is the best way to distinguish documentation and coding from real case mix change and adjust payments for increases due to documentation and coding and not changes in case mix. STS has previously urged CMS to recognize registry-based reporting and mandate participation in a systematic database for cardiac surgery utilizing risk-adjusted clinical data in formulating hospital payment policy. STS believes that it can assist in determining a true case mix based on clinical data that is collected by the STS National Database (Database). We envision a methodology that would identify patient data in the Database and match it to IPPS claims as a possible step in helping determine case mix changes relative to documentation and coding changes. We welcome the opportunity to assist CMS in developing an improved methodology. STS recommends that CMS reassign MitraClip Therapy procedures (ICD-9 code 35.97) from MSDRGs 250-251 to MS-DRGs 216-218 for FY 2013. This would represent a more appropriate assignment for MitraClip procedures from a clinical coherence perspective and because MitraClip procedures use significant resources that are not reflected in the current MS-DRG assignment. Section II. F. Preventable Hospital-Acquired Conditions (HACs), Including Infections Since October 1, 2008, if a patient develops certain hospital-acquired conditions (HAC) during the inpatient hospital stay, the discharge is not eligible to be assigned to a higher paying MS-DRG. The selected HACs are among those that CMS determines: (1) are high cost, high volume, or both; (2) would result in the assignment of a case to an MS-DRG that was a higher payment when present as a secondary diagnosis; and (3) could reasonably have been prevented through the application of evidence-based guidelines. For FY 2013, CMS proposes to add Surgical Site Infection (SSI) Following Cardiac Implantable Electronic Device (CIED) Procedures and Iatrogenic Pneumothorax with Venous Catheterization as conditions subject to the HAC payment provision. STS does not agree with CMS’ proposal to add these conditions to the HAC list until the payment methodology includes appropriate risk adjustment. STS is intent on helping to reduce avoidable health care complications and conditions in cardiothoracic surgery, and has spent many years of data collection and participant feedback working toward this goal. STS has articulated in previous comments to CMS that any payment methodology aimed at addressing avoidable complications that otherwise would qualify a hospital or other health care provider for higher reimbursement should include a risk adjustment component. We are concerned that CMS has continued to add additional components to the HAC list without fully understanding the impact of appropriate risk adjustment. As such, STS is concerned with the manner in which the current HAC payment policy has

June 25, 2012 CMS Acting Administrator Tavenner Page 3 been implemented and how it will be incorporated into the Hospital Value-Based Purchasing Program (VBP). First, STS does not believe that punitive payment mechanisms alone are the most appropriate or effective methods to reduce complications. Rather, the best way to reduce hospital or health careacquired conditions is through measurement, feedback, and focused systems efforts at improvement. Second, STS believes that the HAC methodology should include risk adjustment. The lack of risk adjustment combined with a punitive-payment approach may lead to adverse consequences, including coding changes, a dramatic increase of POA-coded conditions, or worse, jeopardized access to care for patients who are most likely to have or acquire these complications. Toward this end, STS supports implementation of Sec. 3008 of the Affordable Care Act, which modifies the current HAC payment policy by requiring the Secretary of HHS to employ an appropriate risk-adjustment methodology so that hospitals are not unfairly punished for health care-acquired conditions that are not always avoidable. We encourage CMS not to add new items to the HAC list until it implements a robust risk adjustment process. Section II. G. 9. Changes to the ICD-9-CM Coding System, Including Discussion of the Replacement of the ICD-9-CM Coding System with the ICD-10-CM and ICD-10-PCS Systems in FY 2014 The International Classification of Diseases, 10th Revision (ICD-10) coding system applicable to hospital inpatient services is scheduled to be implemented on October 1, 2013. In the January 16, 2009, ICD-10-CM and ICD-10-PCS final rule, there was a discussion of the need for a partial or total freeze in the annual updates to ICD-9-CM, ICD-10-CM and ICD-10-PCS codes. After multiple meetings, CMS announced at the September 15–16, 2010, ICD-9-CM Coordination and Maintenance Committee meeting that a partial freeze of both ICD-9-CM and ICD-10 codes would be implemented as follows: Date

Activity

October 1, 2011

Last regular annual update to both ICD-9-CM and ICD-10.

October 1, 2012

Limited code updates to both the ICD-9-CM and ICD-10 coding systems to capture new technologies and new diseases.

October 1, 2013

No updates to ICD-9-CM, as the system will no longer be a HIPAA standard. There will only be limited code updates to ICD-10 code sets to capture new technology and new diseases.

October 1, 2014

Regular updates to ICD-10 will begin.

However, in a separate, proposed rule (CMS-0040-P), CMS proposed to delay implementation of ICD10 from October 1, 2013 to October 1, 2014. CMS also proposed that the one-year delay will not result in a need to alter the coding freeze.

June 25, 2012 CMS Acting Administrator Tavenner Page 4 STS supports the implementation of the partial code freeze. We agree with CMS that there is a need to allow providers time to prepare for the implementation of ICD-10 and the accompanying system and product updates. The transition to ICD-10 will be quite costly to providers, and it comes at a time of tight budgets for health care entities. Accordingly, we support the limited freeze described above and urge CMS to delay ICD-10 implementation until October 1, 2014. Section VIII.A. Hospital IQR Program Under the IQR program, CMS proposes to change the quality measure set including the removal of 17 quality measures and the addition of five new ones. With regard to the 17 measures, we support CMS’ continued desire to reduce duplication of measure concepts within programs and to utilize National Quality Forum (NQF)-endorsed measures where feasible. Furthermore, we support the concept of the inclusion of a Safe Surgery Checklist measure because we have observed how the implementation of processes of care result in optimal surgical outcomes. In fact, STS disseminates Patient Safety Checklists in each of the main areas of cardiothoracic surgery to its members: • • •

Adult Cardiac Surgery 1 General Thoracic Surgery 2 Congenital Heart Surgery 3

We would caution against an overly prescriptive measure that would prevent surgeons from developing safe surgery protocols that meet the specific needs of their patients. Further, we recommend measure specifications that allow for modifications to the checklist or use of other established and effective checklists. In addition, we support the proposed inclusion of the four Tobacco Cessation measures in future rulemaking cycles. We agree that their inclusion should be delayed until electronic health record (EHR)based data collection mechanisms are available. As CMS facilitates this reporting option, we suggest that interoperability of EHR systems and clinical registries be a major consideration. This will enable inclusion of data from registries that include smoking cessation data elements. Such interoperability will also facilitate the transition of data collection and reporting from chart-abstraction into EHR and clinical registries. In proposing to include the Hospital-Wide All-Cause Unplanned Readmission measure, CMS intends to tackle high readmission rates for a wider range of conditions and procedures. We agree with the overall intent of this measure but we would like to emphasize the necessity of implementation using an appropriate risk-adjustment model that will adequately account for differences in patient clinical characteristics within and across hospitals. We oppose the proposed CMS readmission policy for heart failure patients given these three following scenarios:

1

http://www.sts.org/sites/default/files/documents/powerpoint/ADULT_-_WF_on_PS-CHE.ppt http://www.sts.org/sites/default/files/documents/powerpoint/GENERAL_THORACIC_-_W.ppt 3 http://www.sts.org/sites/default/files/documents/powerpoint/CONGENITAL_-_WF_on_P.ppt 2

June 25, 2012 CMS Acting Administrator Tavenner Page 5 •

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It is reasonable and current practice amongst contemporary heart failure/transplant centers to medically optimize a heart failure patient and then discharge that particular patient from the hospital for a subsequent planned VAD implantation within 30 days. This type of planned readmission for VAD implantation should not be counted as a readmission for heart failure. It is reasonable and current practice that a heart failure patient may be discharged from the hospital and return within 30 days if a suitable heart donor has become available leading to transplant. Similarly, it is possible that a heart failure patient implanted with a VAD as bridge-totransplant may return to the hospital within 30 days for transplantation if a suitable donor has become available. It is reasonable and current practice for a heart failure center to accept in transfer a patient from another center within 30 days of discharge to offer more intensive therapy- i.e. VAD or heart transplant. In this case, the center referring this patient for more advanced therapies should not be penalized with a readmission.

4. Possible New Quality Measures and Measure Topics for Future Years CMS has proposed a list of Hospital IQR program measures and topics to be considered in future IQR reporting requirements. We appreciate that CMS has articulated its priorities for selecting quality measures for the IQR program. STS is currently collecting data on the cardiac surgery measures and supports their inclusion in the IQR. In addition to the measures listed, STS supports inclusion of the following measures and topics: • Coronary Artery Bypass Graft (CABG) 30-day risk standardized readmission rate • All-patient condition-specific readmission rates for Acute Myocardial Infarction (AMI), heart failure, pneumonia, Coronary Artery Bypass Graft (CABG), Chronic Obstructive Pulmonary Disease (COPD), Percutaneous Coronary Interventions (PCI), other vascular conditions • Overall inpatient hospital average length of stay (ALOS) and ALOS by medical service category • Short half-life prophylactic administered preoperatively redosed within 4 hours after preoperative dose • Cardiac rehabilitation referral for AMI, heart failure, cardiac surgery • Heart Failure – Symptom and activity assessment STS also supports maintaining participation in a systematic database for cardiac surgery as a structural measure under the IQR program. STS believes that measures should be endorsed by a multi-stakeholder organization and should be developed through a rigorous and stringent process that is transparent, physician-led, and consensus-based. Section IV. E. IME Adjustment STS supports the CMS proposal to continue the IME adjustment factor at 5.5 percent for every 10percent increase in the hospital’s resident-to-bed ratio. This adjustment factor is the result of a formula and multiplier that have remained unchanged since 2008. STS is committed to graduate medical education, the practice of academic medicine, and the successful training of cardiothoracic surgical residents. Accordingly, we support the continued IME adjustment factor as IME Medicare payments are a crucial component of ensuring a strong cardiothoracic surgery workforce, which is currently experiencing a growing shortage as cited in the report Shortage of Cardiothoracic Surgeons is Likely by 2020, published in the journal Circulation, July 27, 2009.

June 25, 2012 CMS Acting Administrator Tavenner Page 6 On behalf of the Society, thank you for the opportunity to provide these comments on the FY 2013 IPPS proposed rule. If you have any questions, please contact Phil Bongiorno, STS Director of Government Relations, at (202) 787-1221 or [email protected]. Sincerely,

David A. Fullerton, MD Second Vice President/Secretary