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September 6, Dear Ms. Tavenner:

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Administrator

Centers for Medicare and Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW

Washington, DC 20201

Re: CMS-1600-P, Medicare Programs: Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule and Other Revisions to Part B for CY 2014

Dear Ms. Tavenner:

On behalf of the over 50,000 members of the American Society of Anesthesiologists (ASA), we appreciate the opportunity to comment on the Physician Fee Schedule Proposed Rule (CMS-1600-P) that was published in the Federal Register on July 19, 2013.

General Comments

ASA commends the Centers for Medicare and Medicaid Services (CMS) for maintaining the current federal physician supervision safety standard for anesthesia services even as some have suggested removing Medicare’s anesthesia supervision safety standard. Substituting nurses for physicians would significantly decrease patient safety and quality of care. Further, such a substitution provides the Medicare program and taxpayers with no additional cost savings since Medicare pays the same for anesthesia services whether they are furnished by nurse anesthetists or highly-trained physician anesthesiologists. Such a rule change also does nothing to enhance access to surgical and anesthetic care for Medicare beneficiaries. We urge CMS not to lose sight of the fact that giving and receiving anesthesia is dangerous and life-threatening. Anesthesia should only be safely undertaken under the direct administration or supervision of a physician who has the extensive and necessary educational training and experience.

ASA has worked to develop and propose measures that demonstrate the important role of the physician anesthesiologist in patient safety, quality of care and the patient’s rapid return to health following procedures. Physician anesthesiologists are eager to report the quality of the care they provide. However, ASA remains concerned that physician anesthesiologists do not yet have more measures to report for the Physician Quality Reporting System (PQRS). For that reason, we urge CMS to maintain the current requirement to report three measures instead of raising that number to nine. We request CMS adopt the four measures ASA submitted for approval in July of this year. The lack of measures for anesthesiology has implications beyond PQRS, as it will affect physician anesthesiologists’ participation in the value-based payment modifier (VBPM)

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program. We urge that CMS affirm the number of measures required for PQRS reporting should not exceed the number of measures applicable to a specialty. In other words, the minimum number required cannot exceed the maximum number applicable to any Eligible Professional (EP).

We are optimistic that physicians may have the opportunity to report measures through a Qualified Clinical Data Registry (QCDR), but we urge CMS to provide QCDRs with the flexibility and independence necessary to develop, define, and hone their measures. We trust that QCDRs will develop meaningful, defensible and robust measures to positively impact EP reporting and patient care. To align with other reporting mechanisms, we request CMS implement a three-measure threshold requirement for the QCDR provision.

We also provide detailed comments on the ultrasound equipment recommendations, potentially misvalued codes, the Medicare Economic Index (MEI), requirements for billing “incident to” services, complex chronic care management services, the Physician Compare web site, the Electronic Health Record Incentive Program and the VBPM.

Ultrasound Equipment Recommendations for Particular Services

CMS is proposing two changes to the inputs associated with CPT® code 76942 – Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation. Specifically, CMS proposes to:

 Change the equipment input from EL015 (general ultrasound room) to EQ250 (portable ultrasound machine); and

 Reduce the procedure time from 45 minutes to 10 minutes, based on an analysis of the underlying procedures with which this code is used.

CPT code 76942 has already been flagged as a potentially misvalued service in 2011 by the “CMS/Other—Utilization greater than 500,000” screen. Several specialty societies, including ASA, have agreed to survey the code and to present the results of the survey to the AMA/Specialty Society RVS Update Committee (RUC). Per established process, the RUC review will include both work and practice expense. As such, ASA believes CMS should withhold action on this code until that review is complete and the RUC recommendations have been forwarded to CMS. Doing so will ensure that decisions concerning the inputs associated with this code will be based on current data garnered from a multi-specialty survey. That information represents an important factor CMS should consider when making a decision about the value of this code. The underlying principle is to ensure that these services, and all services, are appropriately and accurately valued within the physician fee schedule.

Reducing the time for CPT code 76942 to align with the time it may take to perform the underlying injection or biopsy is not a straightforward assumption. CMS states that the most common underlying procedure is a large joint injection (CPT code 20610) but that viewpoint is

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not necessarily shared by the specialties whose members perform and report the ultrasound guidance as described with CPT code 76942. Moreover, CPT code 76942 includes supervision and interpretation, which represents both time and work that is separate from the surgical code. CMS will be in a better position to make more accurate determinations if it waits for the data that will come from the surveys and the RUC review before making any decisions about CPT code 76942.

Potentially Misvalued Codes

In addition to the practice expense issues noted above, the proposed rule also provides notification that CPT code 76942 has been flagged as potentially misvalued per Contractor Medical Director (CMD) review with one CMD suggesting this ultrasound guidance be bundled into a large joint injection (CPT code 20610) based on review of claims received in his/her jurisdiction. That observation does not correspond with the utilization data for CPT codes 76942 and 20610. CPT code 20610 was reported to Medicare more than 6 million times in 2012; the utilization for CPT code 76942 was far less. The numbers simply do not support bundling as suggested. As noted above, CMS will be in a better position to make more accurate determinations if it waits for the data that will come from the surveys and the RUC review before making any decisions about CPT code 76942.

Medicare Economic Index – Revising of the Medicare Economic Index (MEI)

The MEI is a vitally important component of the Sustainable Growth Rate formula and ASA acknowledges and appreciates CMS’s commitment to use the most current and accurate data and processes available to maintain it. We were pleased that CMS convened a Technical Advisory Panel (TAP) to conduct a thorough review of the MEI components. MEI and all components of the Medicare Physician Fee Schedule must be accurate. We support the changes CMS proposes to implement as based on the recommendations of the TAP.

Requirement for Billing “Incident To” Services

ASA has a long history of advocacy for patient safety. We have been steady and strong in our stance that patients should receive care only from health care professionals that are qualified to provide it. As such, we support the recommendation proffered by the OIG in its 2009 report titled Prevalence and Qualifications of Nonphysicians Who Performed Medicare Physician Services (OEI-09-06-00430) that CMS revise the “incident to” rules to, among other things, “require that physicians who do not personally perform the services they bill to Medicare ensure that no persons except…non physicians who have the necessary training, certification, and/or licensure, pursuant to State laws, State regulations, and Medicare regulations personally perform the services under the direct supervision of a licensed physician.” We encourage CMS to demonstrate this same level of concern and scrutiny for all care rendered to Medicare beneficiaries.

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Complex Chronic Care Management Services

We believe that complex chronic care management is not just in the realm of primary care and there are opportunities for care management in the surgical and perioperative setting. Currently, there is no coordinated and widely adopted construct to improve quality of care and outcomes while ensuring patient safety and achieving cost savings across the widest possible range of surgical interventions. Leading institutions, including the Mayo Clinic, have implemented innovative perioperative measures and protocols that simultaneously improve patient outcomes and decrease costs. These models serve as the foundation for the Perioperative Surgical Home model. The Perioperative Surgical Home model strives to optimize care of patients undergoing surgery by incorporating such novel practices with increased integration of physician anesthesiologists throughout the perioperative period. This concept now needs to be tested widely. The goals of the Perioperative Surgical Home model include:

 Increase the ability of beneficiaries to participate in decisions concerning their care;  Provide delivery of care that is consistent with evidence-based guidelines in historically

underserved areas; and

 Decrease unjustified variation in utilization and expenditures under the Medicare program.

The Perioperative Surgical Home model will evaluate and measure the potential for coordinated management of surgical patients to reduce complications, produce innovative process improvements, and consequently enhance the value of surgical care. Physician anesthesiologists are the common point of contact for patients undergoing major procedures from the neonate to the centenarian, across all surgical disciplines. From this position, physician anesthesiologists communicate and coordinate care on a daily basis with patients and all members of the surgical team. By empowering and incentivizing physician anesthesiologists to participate more broadly in patient care, the Perioperative Surgical Home model will promote improved communication, teamwork and attention to patient-centered care. Through increased patient engagement and improved care coordination, this model has the potential to improve patient satisfaction along with other outcome measures. Encouraging physician anesthesiologists to utilize their well-honed skills in efficient patient evaluation and management, as well as their expertise in systems optimization throughout the perioperative period, will improve quality and efficiency in the health care system. ASA is engaged in ongoing work to develop this innovative model of care. Physician Compare Web Site

ASA supports transparency in allowing consumers to review performance and quality data of physicians. CMS must ensure fair and accurate reporting by improving the database. ASA members have expressed concern that their publicly available information is either incomplete or incorrect. In one recent example (see below), the Physician Compare website listed Norman A. Cohen, M.D., physician anesthesiologist, as affiliated with St Charles Medical Center, when in fact he had never worked, nor been privileged at that particular hospital.

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We believe there should be sufficient time for physicians to review and appeal, if appropriate, information posted and to be posted on the Physician Compare web site. Physicians should have the opportunity to dialogue with CMS before and after the relevant information is posted.

Information provided on Physician Compare must be timely and current. We note that PQRS reporting lags the performance of the service by 12-18 months. We encourage CMS to reduce the lag time associated with reporting. This is particularly important when physicians need to review their information.

Since CMS is moving toward posting extensive and complex quality data on Physician Compare, we believe the 30-day review period, prior to public posting, is inadequate. The Affordable Care

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Act gives the Secretary the flexibility to define the review period. ASA recommends that CMS extend the review period to allow 90 days for an EP to review and appeal his/her information. In addition, we propose that within that time period, provisions be made to “stop the clock” while appeals are being adjudicated. ASA understands that provisions must be in place so that the process of reviewing and, if appropriate, challenging the data is not abused by EPs.

Physician Payment, Efficiency, and Quality Improvements—Physician Quality Reporting System

Increasing the required number of measures that must be reported from the current three measures to nine as proposed will be a significant challenge for physician anesthesiologists to overcome. ASA argues that CMS apply a more effective strategy to ensure that specialty EPs, such as physician anesthesiologists, are reporting on the quality of patient care received and not just the quantity of services provided. ASA proposes that CMS refrain from increasing the minimum number of measures to report until the agency maximizes participation in the current PQRS reporting system. Physician anesthesiologists are the most engaged and successful in implementing PQRS into their practices. Physician anesthesiologists have been cited as reporting PQRS measures at a higher average rate than other specialties, but reporting mechanisms and requirements do not permit their reporting to capture the totality of care provided by physician anesthesiologists in many care settings.

Physician anesthesiologists provide care in a variety of settings and their performance, working in tandem with surgeons and other EPs, impacts patient outcomes. Currently, physician anesthesiologists have only three anesthesia-specific PQRS measures to report, Measures #30, #76 and #193. While these measures may have allowed physician anesthesiologists to meet the minimum threshold for reporting in the past, these three measures do not necessarily apply to all physician anesthesiologists. For example, physician anesthesiologists providing the single most common anesthesia service, CPT code 00142 – Anesthesia for lens surgery, will find that none of these three PQRS measures is applicable to their patients. ASA recognizes CMS’s desire to expand the use of measures and ASA is proactively seeking solutions to meet that challenge in the next few years. But at this time, we find it unreasonable that EPs be expected to report more measures than are currently available to them. Moving forward with this proposed rule will effectively remove physician anesthesiologists from participating in the PQRS system.

ASA requests that CMS recognize genuine efforts made by specialty societies, including ASA, to develop meaningful quality measures for their members. We request that CMS not penalize an EP by this aggressive proposal to increase the number of measures to report. We request that CMS create a better balance between the quality of measures that EPs report and the quantity of reportable measures.

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ASA supports the goals of the National Quality Strategy (NQS), but at this time, physician anesthesiologists do not have the ability to report on measures across three domains. Both of these features, the number of measures to report and the domains that the measures must cover, remain significant obstacles to satisfactory reporting under the policies in the proposed rule. CMS is moving toward elimination of the claims-based reporting mechanism and is seeking comment as to whether that mechanism should be eliminated in 2017. Some of the actions described in the proposed rule would sharply curtail claims-based reporting even sooner. This swift transition away from reporting via claims undermines the ability of EPs to have a sufficient number of measures to report. ASA believes that CMS should revisit how reporting via claims has been institutionalized among EPs, including physician anesthesiologists. According to the proposed rule, “approximately 72 percent of eligible professionals (229,282 out of 320,422 eligible professionals) participating in PQRS in 2011 did so using the claims-based reporting mechanism.” A significant majority of physician anesthesiologists report via claims; the addition of several dozen measures that do not include the claims-reporting option further hampers the ability of physician anesthesiologists and other EPs to meet the proposed nine-measure threshold.

ASA agrees with CMS that registry reporting offers fewer errors than claims reporting, but CMS must acknowledge the barriers that many EPs have with using a registry, especially as fewer options are available for reporting measures via claims. ASA cautions CMS on prematurely removing provisions for physicians to report measures via claims. At this time, a majority of physician anesthesiologists report PQRS measures via claims. Although ASA and the Anesthesia Quality Institute (AQI) have established mechanisms for physicians to report via a registry, CMS must support this transition by ensuring that all EPs are able to capture and report quality measures using registries or EHRs before making dramatic cuts to claims-based measures. ASA proposes that CMS monitor the transition of EPs reporting via claims to those reporting via a registry and allow some flexibility for physicians to continue reporting via claims.

ASA is very concerned about the confusion that may ensue given that CMS finalized certain aspects of the 2014 PQRS program in 2013 but did not mention them in this proposed rule. Compounding the matter even further, CMS opened some of those aspects for reconsideration and comment in this proposed rule, a rule that CMS itself describes as “major.” Straddling the criteria across two rules has made it very difficult for commenters to view a full and complete picture of the criteria that will be required for 2014. This observation pertains to both the 2013 and the 2014 programs, specifically in reference to the rule for claims-based reporting when an EP reports fewer than the minimum number of measures. Previously, when the standard was three measures, EPs reporting one or two measures would be eligible for incentive if the Measure Applicability Validation (MAV) process confirmed that the EP reported on all measures that were applicable to his/her patients. CMS is now proposing to increase the minimum number of measures to nine measures that cover three NQS domains. CMS has provided information (in a setting separate from this proposed rule) stating that, “Individuals reporting via claims may report three measures and still avoid the payment adjustment” but “[t]his option will not fulfill

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the satisfactory reporting requirements to earn the 2014 PQRS incentive.”1 Because CMS has proposed such a significant change to 2014 PQRS, namely increasing the required number of measures from three to nine, we believe that the previous action to limit the applicability of the MAV process deserves reconsideration. Until such time that CMS acts and approves new measures for physician anesthesiologists, CMS must maintain a pathway for these EPs to demonstrate through MAV that they have indeed reported on all measures applicable to their practice. We again emphasize, the minimum number of required measures cannot exceed the maximum number applicable to any EP. If CMS increases the required number of measures, CMS should confirm that EPs reporting fewer than nine measures via the claims-based mechanism are eligible for the 2014 PQRS Incentive subject to the MAV process.

We respectfully request that CMS make more effort to present such material changes in a more open and consistent manner. Tables within the rules are intended to summarize the information detailed in the text but all significant changes should be very clearly presented in the rules as published.

In recent years, ASA has worked proactively to protect and expand the number of measures our members may report. We have developed a comprehensive strategy to ensure physician anesthesiologists will have the ability to report meaningful quality measures and meet CMS requirements in the future. This strategy includes:

 Propose measures for PQRS inclusion;

 Engage ASA members and resources to develop evidence-based quality measures;  Incorporate CPT codes that describe anesthesia services into existing measures; and  Advocate for a balanced transition from claims to registry reporting.

In July 2013, ASA submitted four measures to CMS for inclusion in PQRS 2015. The measures, although process in nature, contribute to meaningful patient outcomes and return to health. Those measures are:

 Post-Anesthetic Transfer of Care: Use of Checklist or Protocol for Direct Transfer of Care from Procedure Room to Intensive Care Unit (ICU);

 Prevention of Post-Operative Nausea and Vomiting (PONV) – Combination Therapy (Adults);

 Prevention of Post-Operative Vomiting (POV) – Combination Therapy (Pediatrics); and

 Continuation of Preoperative Use of Aspirin for Patients with Coronary Artery Stents.

1

Kate Goodrich, M.D., M.H.S. Acting Director, Quality Measurement & Health Assessment Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services; August 1, 2013 presentation at AMA, Washington, DC

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We request that CMS include these four measures in PQRS 2015.

ASA appreciates how CMS has judiciously used its authority to use non-National Quality Forum (NQF) endorsed measures in its performance programs. At the same time, we feel that CMS has not acted within its capacity or expertise to explain why certain proposed PQRS measure submissions were rejected. ASA believes that constructive yet pointed criticism of a rejected measure would not compromise CMS’s future decision-making authority but serve to direct the energies of specialty societies toward making hard decisions regarding dropping or revising the rejected measure. We ask that CMS respond to specialty-submitted non-NQF endorsed measures within 90 days of submittal.

ASA continues to work with its members, physician-led committees, and the AQI to develop meaningful quality measures that will recognize an anesthesiologist’s actions while promoting patient outcomes. ASA recognizes the direction of CMS and other quality organizations in moving from process measures to outcomes measures. Because of this direction, ASA and the AQI are focusing additional attention on developing outcome measures. For physician anesthesiologists, this may mean a greater emphasis on intermediate outcomes. Physician anesthesiologists often identify patient outcomes at shorter intervals rather than a 30 or 90-day postoperative outcome measure framework. We ask that CMS continue to recognize the potential that short-term or intermediate outcomes have upon the care a patient receives, whether the measure occurs when the patient leaves the postanesthesia care unit (i.e. PONV) or after a one-to-seven day period (i.e. development of pneumonia, headache, or other postoperative complications).

ASA seeks further collaboration among CMS, Measure Stewards, and Specialty Societies on existing PQRS Measures. ASA believes that collaboration between specialty societies and measure stewards has the potential to improve patient care and recognize EPs for the services they perform. Beginning in PQRS 2014, physician anesthesiologists will be able to report on PQRS Measure #44: Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery. This past summer, ASA constructively worked with CMS and the Quality Insights of Pennsylvania (QIP) to include anesthesia CPT codes in the measure denominator. Physician anesthesiologists collaborate daily on the care of patients; this is meaningful not just to physician anesthesiologists, surgeons or other EPs, but most importantly to patients. The process demonstrated to ASA that CMS and its contractors are implementing what has been desired for several years: support of team-based measures with shared accountability. ASA thanks CMS and QIP for their discussions, deliberation and inclusion of anesthesia CPT codes in PQRS Measure #44.

In conversations ASA has held with its members as well as with different measure stewards, it is clear that there is a path forward to rethinking and implementing team-based measures through the existing PQRS infrastructure. ASA seeks to build upon what medical professionals have understood for years – that recognition of each member of a patient’s care team informs upon

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and has the potential to improve patient outcomes. ASA requests that CMS support the expansion of team-based measures with shared accountability by proposing guidelines to help measure stewards prudently yet expeditiously amend measure specifications.

ASA requests CMS and measure stewards consider the inclusion of anesthesia CPT codes into select measures, measure groups, and patient satisfaction reporting mechanisms as proposed. ASA seeks to build upon the collaborative experience by requesting CMS and measure stewards, listed in the chart below, carefully consider how physician anesthesiologists may be able to contribute to and report on the proposed measures. We look forward to the release of full measure specifications in the upcoming months that will shed additional light on satisfactorily reporting these proposed measures.

ASA reviewed the proposed rule, noting where a physician anesthesiologist’s actions may contribute to the delivery of quality care and, more importantly, patient outcomes. ASA believes the following measures have the potential to include anesthesia CPT codes and we request that CMS work with us and the measure stewards to ensure physician anesthesiologists are appropriately recognized for their care of the patient.

Excerpt from the 2014 Proposed Rule (Table 29)

Measure  Steward  Closing the referral loop: receipt of specialist report   CMS  Screening Colonoscopy Adenoma Detection Rate Measure   ACGAGA/ASGE  Total Knee Replacement: Venous Thromboembolic and Cardiovascular Risk  Evaluation   AAHKS / AMA‐PCPI  Total Knee Replacement: Preoperative Antibiotic Infusion with Proximal  Tourniquet  AAHKS / AMA‐PCPI  Optimizing Patient Exposure to Ionizing Radiation: Computed Tomography  (CT) Images Available for Patient Follow‐up and Comparison Purposes  AMA‐PCPI    Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed  Tomography (CT) Studies Through a Secure, Authorized, Media‐Free, Shared  Archive   AMA‐PCPI    Rate of Endovascular Aneurysm Repair (EVAR) of Small or Moderate Non‐ Ruptured Abdominal Aortic Aneurysms (AAA) who Die while in Hospital  SVS 

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Measure  Steward  Rate of postoperative stroke or death in Asymptomatic Patients undergoing  Carotid Endarterectomy (CEA)  SVS  Rate of postoperative stroke or death in Asymptomatic Patients undergoing  Carotid Artery Stenting (CAS)  SVS  Rate of Major Complications (Discharged to Home by Post‐ Operative Day #2)  Carotid Artery Stenting (CAS) for Asymptomatic Patients, without Major  Complications (Discharged to Home by Post‐Operative Day #2)  SVS  HRS‐3: Implantable Cardioverter Defibrillator (ICD) Complications Rate  HRS  Pain Brought under Control within 48 Hours  NHPCO  Maternity Care: Elective Delivery or Early Induction Without Medical  Indication at >=37 and < 39 weeks (Overuse)   AMA‐PCPI  Patient‐Centered Surgical Risk Assessment and Communication  ACS  Ventral Hernia, Appendectomy, AV Fistula, Cholecystectomy, Thyroidectomy,  Mastectomy +/‐ Lymphadenectomy or SLNB, Partial Mastectomy or Breast  Biopsy/Lumpectomy +/‐ Lymphadenectomy or SLNB  ACS  Ventral Hernia, Appendectomy, AV Fistula, Cholecystectomy, Thyroidectomy,  Mastectomy +/‐ Lymphadenectomy or SLNB, Partial Mastectomy or Breast  Biopsy/Lumpectomy +/‐ Lymphadenectomy or SLNB: Unplanned Hospital  Readmission within 30 Days of Principal Procedure  ACS  Ventral Hernia, Appendectomy, AV Fistula, Cholecystectomy, Thyroidectomy,  Mastectomy +/‐ Lymphadenectomy or SLNB, Partial Mastectomy or Breast  Biopsy/Lumpectomy +/‐ Lymphadenectomy or SLNB: Surgical Site Infection  (SSI)  ACS  Bariatric Laparoscopic or Open Roux‐en Y Gastric Bypass, Bariatric Sleeve  Gastrectomy, and Colectomy: Anastomotic Leak Intervention  ACS  Bariatric Laparoscopic or Open Roux‐en Y Gastric Bypass, Bariatric Sleeve  Gastrectomy, and Colectomy: Unplanned Reoperation within the 30 Day  Postoperative Period  ACS 

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Measure  Steward  Bariatric Laparoscopic or Open Roux‐en Y Gastric Bypass, Bariatric Sleeve  Gastrectomy, and Colectomy: Unplanned Hospital Readmission within 30  Days of Principal Procedure  ACS  Bariatric Laparoscopic or Open Roux‐en Y Gastric Bypass, Bariatric Sleeve  Gastrectomy, and Colectomy: Surgical Site Infection (SSI)  ACS  VTE‐2: Intensive Care Unit Venous Thromboembolism Prophylaxis  TJC  VTE‐4: Venous Thromboembolism Patients Receiving Unfractionated Heparin  with Dosages/Platelet Count Monitoring by Protocol  TJC  H‐CAHPS: Hospital Consumer Assessment of Healthcare Providers and  Systems Survey  AHRQ 

Although this is a preliminary list, the measures above are identified as having the potential to be team-based measures with shared accountability. We ask that CMS allow claims-based reporting for applicable proposed 2014 PQRS measures. These measures demonstrate that physician anesthesiologists provide patient care in multiple settings. We support the proposal to allow hospital-based physicians to elect to have their hospital’s performance scores attributed to them. We also agree with the proposal that Hospital Inpatient Quality Reporting (IQR) measures be retooled for use in the PQRS.

ASA requests clarification and safeguards concerning the development and use of proposed measure groups. ASA is concerned that the arbitrary inclusion of individual measures into these measure groups that will further constrain an EP from meeting even the current measure reporting requirements. ASA requests that measures included in the designated measure groups may be reported as individual measures.

ASA is apprehensive that the administration of certain measure groups may limit the development of team-based measures. In previous years, EPs would be required to report on all measures contained in the measures group. As noted above, physician anesthesiologists may now report on PQRS Measure #44. In the proposed rule, CMS has affixed PQRS Measure #44 to a measures group that includes multiple CABG measures. Since physician anesthesiologists may not currently report on the other measures proposed for that group, it is unclear if this would mean that physician anesthesiologists could now report on the other measures or if anesthesia CPT codes would be removed from PQRS Measure #44.

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ASA requests that CMS expand its proposed Group Practice Reporting Option (GPRO) reporting provision related to CG-CAHPS to include S-CAHPS reporting. CMS has proposed that physicians who report on CG-CAHPS may have their required nine measures across three NQS domains reduced to six measures across two NQS domains. Since CG-CAHPS is directed toward measuring patient satisfaction and care received from a primary care physician, ASA believes that additional options should exist for physician anesthesiologists to receive patient feedback and, in turn, receive PQRS credit. At the same time, ASA expresses reservations about the cost burden associated with requiring smaller physician groups to contract with a survey vendor. This additional practice cost may discourage or even prevent these practitioners from seeking out patient input and measuring patient satisfaction. ASA is concerned that this cost burden may exceed the incentive benefit of conducting a survey. ASA understands the importance of patient feedback and how that feedback can improve patient care, quality and safety. The cost burden that may accrue to group practices may have the unintended consequence of reducing the opportunities for patients to report their outcomes and satisfaction.

ASA objects to the proposed deletion of PQRS Measure #321. CMS has proposed the deletion of PQRS Measure #321, a measure allowing physicians to receive credit for reporting to a registry, claiming the measure would be redundant to a QCDR. ASA believes the deletion of this measure is premature. As CMS encourages physicians to move from a claims-based reporting system to a registry and ultimately to a QCDR, ASA believes an incentive must be retained while this transition is taking place. We acknowledge that there may be an appropriate time to remove this measure in the future; however, we believe that CY 2014 is premature. Qualified Clinical Data Registries

ASA has demonstrated its ability to lay the foundation and infrastructure for future CMS data registry provisions through the judicious and prudent development of the AQI and the National Anesthesia Clinical Outcomes Registry (NACOR).

In October 2008, the ASA House of Delegates created the AQI. The AQI receives most of its funding from ASA but it has also received research and development grants from outside entities, including the Patient-Centered Outcomes Research Institute (PCORI). The vision of the AQI is “to become the primary source of information for quality improvement in the clinical practice of anesthesiology.” The mission of the AQI is to develop and maintain an ongoing registry of case data that helps anesthesiologists assess and improve patient care. Individual anesthesiologists, practice groups, researchers, and professional societies are able to report quality metrics to NACOR and use the resulting reporting and comparisons for quality improvement activities.

NACOR collects billing and administrative data, information on quality and perioperative events and as a registered Patient Safety Organization, data on adverse events and near misses. This last feature is codified in the Anesthesia Incident Reporting System (AIRS) and de-identified cases

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from AIRS are routinely used to provide teaching material for physician anesthesiologists, ASA members, and the general public through the ASA NEWSLETTER.

ASA and AQI have laid the foundation for physician anesthesiologists to report meaningful, accurate quality measures. ASA and AQI, in collaboration with the American Board of Anesthesiology (ABA), also operate the Maintenance of Certification in Anesthesiology (MOCA) Practice Performance Assessment and Improvement (PPAI) registry. Participants in MOCA are required to assess the quality of their practice using clinical patient data. All information submitted to the program and run through the registry is protected and we remain vigilant in ensuring data are protected and accurate. For anesthesiologists in practices that participate in NACOR, the AQI plans to go a step further. AQI is piloting a voluntary program that helps providers more easily identify the cases they need to review for their MOCA-PPAI projects. In the future, this system will aid the physicians by identifying data that should be reported. Moreover, ASA, AQI and ABA are collaborating on a project to develop interactive learning and quality improvement modules that focus on individual quality measures. This project aims to broaden the participation of anesthesiologists in PQRS while improving the quality of patient care.

AQI is developing the National Pain Registry aimed at keeping track of long-term pain medicine outcomes. As stated earlier, anesthesiologists perform in a variety of settings, including pain and palliative care settings. AQI recognized the need to adequately measure and address issues related to effective and safe pain medicine several years ago. Working with experts from the American Society for Regional Anesthesia and Pain Medicine (ASRA), AQI has produced templates for data and identified workable definitions. AQI will continue to help participants build these pain measures into existing EHRs such that the data can be periodically transferred and prudently analyzed by AQI.

Although AQI and NACOR must implement additional features of performance prior to being certified as a QCDR, we believe, with some flexibility on the part of CMS, that these challenges will be met in the near future. ASA urges that CMS, however, provide a somewhat broader definition that, while maintaining high standards of reporting, allows for greater latitude for the QCDR to develop measures in a deliberative and meaningful manner. We request additional flexibility to develop measures reflective of the varied anesthesiology practices of our registry members. Although NACOR has collected nearly 12 million cases, internal stakeholders and staff need additional flexibility to define measures and the domain to which these measures would apply. As the process of measure development takes place at the QCDR level, we reiterate our argument that CMS maintain the current PQRS reporting criteria at three measures, whether they are by claim, registry, or QCDR.

ASA requests that CMS provide additional guidance on the definition of an outcome measure as defined under a QCDR. As noted in our discussion of PQRS, we request that CMS recognize the value of short-term and intermediate outcome measures as fulfilling the “outcome” measure provision of the proposed QCDR rule. Physician anesthesiologists often identify patient

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outcomes at shorter intervals than the standard 30-day postoperative norm. We ask that CMS recognize the potential that short-term or intermediate outcomes have upon the care a patient receives, whether the measure occurs when the patient leaves the Postanesthesia Care Unit (i.e. PONV) or after a one-to-seven day period (i.e. development of pneumonia, headache, or other postoperative complications).

ASA requests clarification on whether providers may use multiple QCDRs to meet PQRS requirements. As ASA pursues the inclusion of anesthesia CPT codes into existing and proposed measures, we recognize that these measures may need to be reported via a QCDR maintained by a non-anesthesiology organization. We ask CMS to clarify whether a physician may report to multiple QCDRs to fulfill the requirements for the 2014 PQRS Incentive and the 2016 PQRS Payment Adjustment.

Although the QCDR option allows for non-PQRS measures to be submitted to CMS, we are concerned that CMS may have the ability to challenge and remove measures arbitrarily without allowing for appropriate accommodations to be made for EPs. We recommend CMS ensure that once a QCDR measure has been accepted by CMS, an EP may report on that measure for the proposed 12-month reporting period. This protection will provide a greater sense of security for the EP to meet PQRS requirements.

ASA expresses reservations regarding CMS’s ability to disqualify a QCDR for submitting erroneous or inaccurate data. We request that CMS consider safeguards for EPs in the process so that they are not penalized for the errors of the QCDR.

In the future, the AQI will contribute meaningful data on measures to CMS as a QDCR. ASA recognizes the expedited timetable CMS has had to use to develop the core features of a QCDR. ASA and the AQI are excited about the potential a QCDR will have in measuring patient care and outcomes as well as contributing to meaningful research to improve that care and those outcomes. We ask that CMS recognize that AQI, as with other registries, may need additional time to upgrade their systems to meet the requirements proposed in the rule.

Electronic Health Record (EHR) Incentive Program

ASA appreciates CMS’s efforts to align the PQRS and EHR Incentive Program and welcomes that CMS would allow registry reporting to meet the Clinical Quality Measure (CQM) requirement of meaningful use. This is especially important as many measures lack e-specifications and for purposes of meaningful use, physicians often report zeros on measures that are inapplicable to their practice simply for the sake of reporting. We would like to reiterate that the number of measures required under PQRS or QCDRs should not exceed the number of measures available to an EP.

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We greatly appreciate that CMS created a hardship exception for physician anesthesiologists in the Stage 2 Final Rule. We believe this important hardship exception must be maintained in Stage 3 and beyond. Additionally, we support modifying the criteria so that physician anesthesiologists can successfully participate in the program. As of July 12, 2013, only 2,779 EPs with the specialty designation of anesthesiology have received the incentive. We look forward to working with CMS in developing regulations pertaining to Stage 3 of the EHR Incentive Program.

Value-Based Payment Modifier and Physician Feedback Program

As participation in the VBPM is predicated on EPs having a robust set of measures, we once again urge CMS to accept the measures ASA has submitted and for CMS to remove roadblocks in the measure development process. The fact that there are so few measures for physician anesthesiologists makes applying the VBPM difficult at this time.

CMS proposes to lower the threshold of groups subject to the VBPM from 100 or more EPs to groups of 10 or more EPs. While we understand the Congressional mandate to eventually subject all groups to the VBPM, 10 is too low at this time. We agree with the American Medical Association (AMA) that 50 EPs or more represents a reasonable next step.

We appreciate that the GPRO is no longer mandatory and that CMS has designed a VBPM entry point that recognizes that many EPs in a group participate in PQRS as individual providers. CMS proposes to recognize a group as a successful PQRS reporter in terms of the VBPM if at least 70% of its members successfully report PQRS as individual EPs. We agree with the AMA that CMS should lower that threshold of EPs so that more groups will have a pathway to success. The Medicare Spending per Beneficiary (MSPB) measure, as proposed, would “attribute an MSPB episode to a group of physicians subject to the value-based payment modifier (as identified by a single TIN), when any eligible professional in the group submits a Part B Medicare claim under the group's TIN for a service rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the performance period for the applicable calendar year payment adjustment period.” However, there is much that requires clarification before implementing this proposal. Importantly, it must be clear how this attribution method will allow practices to make judgments about their resource utilization or alter their practices, as they may still not receive enough actionable data to have an accurate cost profile. The Congressional Budget Office (CBO) has determined that anesthesia services do not drive volume or growth.2 We recommend that all patient encounters should not be weighted equally, as anesthesia encounters are often less costly than other types of care encompassed within the episode. CMS proposes that “a group of physicians would have to be attributed a minimum of 20

2

“Budget Options Volume I Health Care” Congressional Budget Office. December 2008:

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MSPB episodes during the performance period to have their performance on this measure included in the value-based payment modifier cost composite.” We believe that setting a minimum number of episodes is appropriate. However, attributing a patient to a group if “any eligible professional in the group submits a Part B Medicare claim” could defeat the purpose of establishing a minimum number of MSPB episodes.

CMS is considering benchmarking using either a “specialty adjustment” or a “comparability peer grouping” approach. We are concerned that comparability peer grouping would pose logistical challenges for CMS. We also point out that size of a group is irrelevant because it does not account for different practices and different patient mixes. We agree with CMS that “the specialty benchmarking method would be preferable to account for the specialty composition of the group of physicians when making peer group comparisons and creating the standardized score for the cost measures for the value-based payment modifier.”

The Proposed Rule identifies an MSPB episode as the “3 days prior to an index admission at a subsection (d) hospital through 30 days post discharge with certain exclusions.” CMS is seeking comments on whether the episode should be the period so described or whether it should be limited to the index admission time only. ASA is engaged in ongoing work to develop the Perioperative Surgical Home model. Encouraging physician anesthesiologists to utilize their well-honed skills in efficient patient evaluation and management, as well as their expertise in systems optimization throughout the perioperative period, will improve quality and efficiency in the health care system. CMS must be flexible in implementing the VBPM program to allow recognition of this and other evolving new models of delivery.

We commend CMS for proposing to protect groups with fewer than 100 EPs from the downside risk associated with the VBPM. Since this program is still in its early stages and we do not have the lessons learned from the 2015 program to form the 2016 program, we suggest that CMS not finalize its proposal to make quality tiering mandatory. This would allow all groups in the program (regardless of size) some protection from negative risk as long as they meet the threshold for Category 1 classification in the program.

We appreciate your consideration of our comments. If you have any questions please contact ASA’s Director of Payment and Practice Management, Sharon Merrick. M.S., CCS-P (s.merrick@asahq.org) or ASA’s Director of Quality and Regulatory Affairs, Maureen Amos, M.S. (m.amos@asahq.org) at (202) 289-2222.

Sincerely,

John M. Zerwas, M.D. President

References

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