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Public Comments

Date: 2012

September 4, 2012

Marilyn Tavenner
Acting Administrator
 Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attn: CMS-1590-P P.O. Box 8013
Baltimore, MD 21244-8013

 RE: Comments on Proposed Rule for Revisions to the 2013 Medicare Physician Fee Schedule

Dear Administrator Tavenner:

Because of the growing impact atrial fibrillation (AFib) is having on our aging population, the AFib Optimal Treatment Task Force, comprised of 12 leading organizations in the thrombosis space, formed in 2011 to raise awareness of the impact of the disease and to explore issues related to the process used by healthcare providers to assess both stroke and bleeding risk in making decisions about anticoagulation therapy for patients with AFib. We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Rule for Revisions to the 2013 Medicare Physician Fee Schedule. Our comments on the proposed rule will be limited to a new measure #1525, Chronic Anticoagulation Therapy, which is under consideration by CMS for inclusion in the Physician Quality Reporting System (PQRS) for CY2013. Recent expert consensus led by the AFib Optimal Treatment Task Force supports the use of this measure but with an additional recommendation to encourage routine and proper bleeding risk assessment. We urge you to include a modified version of measure #1525 in the final rule that encourages a bleeding risk assessment in addition to a stroke risk assessment to ensure that Medicare beneficiaries with AFib are presented with all treatment options that may be available for them.

General Comments
Atrial fibrillation is associated with an approximate doubling of mortality risk, in large part due to the increased risk of stroke1. Around 82% of Americans with atrial fibrillation are age 65 and older2.With as many as 1 in 10 Americans afflicted with AFib by age 803, it is a pressing problem for our health care system as the Silver Tsunami of older Americans and chronic disease begins to impact Medicare. AFib can be treated and the risk of stroke reduced with appropriate medication and monitoring. However, proper assessment of stroke risk and bleeding risk is critical to appropriately treating patients with AFib and reducing the human and economic burdens associated with the condition.

There are currently conflicting clinical practice guidelines which lead to confusion about how healthcare providers should determine stroke risk and bleeding risk in patients with AFib, what tools should be used, and how best to incorporate scores from these tools into treatment decision-making with their patients. The result is commonly the underutilization of anticoagulants, particularly in older patients who are often at a higher risk of bleeding. Bleeding risk assessment is important because it can uncover risk factors for serious bleeding such as intracranial hemorrhage. It can also identify modifiable risk factors that can be addressed before anticoagulation therapy, however, bleeding risk assessments are frequently not conducted properly or at all. Many healthcare providers over-estimate a patient’s bleeding risk and under-estimate the risk of ischemic stroke. This is especially true among older adults, where the risk of bleeding events related to falls and frailty is often over-estimated. Bleeding risk assessment is not an opportunity to look for reasons not to anticoagulate as the net benefit of stroke prophylaxis supersedes the “net harm” of serious bleeding events in the majority of AFib patients. The underuse of anticoagulants in older patients, including Medicare beneficiaries, is a major obstacle to effective care that reduces morbidity and mortality for this condition and without a proper understanding of bleeding risk assessment and how to address this with patients underuse will continue.

Expert Consensus

The AFib Optimal Treatment Task Force convened a roundtable of experts in cardiology, neurology and other related fields on January 18, 2012 to forge consensus on the best practices for assessing stroke and bleeding risk in anticoagulation decision-making. These experts subsequently developed a consensus statement (see Appendix A) to provide guidance to health care providers on evaluating patients with AFib. In the consensus statement, the experts recommend a three-step approach:

  • First, a patient’s stroke risk should be assessed and recorded no less than annually using an established scoring tool. Those identified as intermediate or high risk should be put on an anticoagulant--warfarin or a direct thrombin inhibitor or a factor Xa inhibitor. Aspirin is not recommended for stroke prophylaxis in AFib.
  • Second, if the patient is at high enough risk to require anticoagulation therapy, the patient’s bleeding risk should then be evaluated to estimate the net clinical benefit of an anticoagulant, again using an available tool as a starting point. Risk factors for intracranial hemorrhage should be considered although routine screening for these risk factors is not currently indicated. For the majority of patients, the net benefit of stroke prophylaxis supersedes the “net harm” of serious bleeding events—even in older patients. The experts also emphasized that assessment of bleeding risk is not an opportunity to look for reasons not to anticoagulate, but an opportunity to address correctable risk factors for bleeding.

 

  • Third, the decision to undergo anticoagulation therapy must reflect patient preferences and values. The patient must also understand the relative benefits and risks involved in the discussion and decision surrounding the clinical net benefit of anticoagulation therapy. The experts involved in this roundtable agree that this process establishes clear steps for assessing risk and making anticoagulant therapy decisions in AFib, and should go a long way toward helping healthcare professionals provide patients with the care needed to prevent stroke. Recommendation Measure # 1525, Chronic Anticoagulation Therapy, was approved by the National Quality Forum earlier this year. The measure recommends the prescription of an anticoagulant for the prevention of stroke for all patients with atrial fibrillation or atrial flutter at high risk for thromboembolism, according to the CHADS2 risk stratification. While the AFib Optimal Treatment Task Force consensus does not recommend a specific stroke risk assessment tool, CHADS2 is one of the established stroke risk assessment tools included in the consensus by the experts. We believe that the inclusion of this measure in PQRS will encourage more routine assessment of stroke risk and help identify those who are truly at high and intermediate risk and should be on an anticoagulant. We support it for this purpose. However, we feel strongly that the additional recommendation for healthcare providers to use an available tool (e.g. HAS-BLED, ATRIA, HEMORR2HAGES) to assess bleeding risk routinely along with stroke risk will enable this measure to more fully meet the needs of patients with AFib.

The more routine assessment of bleeding risk in patients will allow healthcare providers to address correctable risk factors for bleeding, such as uncontrolled hypertension, anemia, renal impairment, labile INRs, concomitant prescription of aspirin or NSAIDs, and reduced platelet count, making those patients potential candidates for anticoagulant therapy. It will also help to better identify those patients at high risk of serious bleeding, such as intracranial hemorrhage. With the exception of those patients with an extremely increased risk of bleeding and a relatively low risk of stroke, those that are identified as having a high risk of bleeding could be monitored closely while on anticoagulant therapy and their correctable bleeding risk factors could be managed. Formalizing stroke risk assessment under measure #1525 is an important step towards improved treatment of AFib patients; however not addressing proper bleeding risk assessment will leave a critical portion of the process for evaluating a patient with AFib in an ambiguous state. Such ambiguity may perpetuate the current trend of underusing anticoagulants in older patients4.
We urge you to include a modified version of measure #1525 in the final rule that encourages a bleeding risk assessment in addition to a stroke risk assessment to ensure that Medicare beneficiaries with AFib are presented with all treatment options that may be available for them.

We appreciate that CMS recognizes the significance of AFib and is targeting healthcare providers in Medicare quality reporting programs related to patient outcomes for this condition. If amended we believe measure #1525 will provide important guidance and an incentive to healthcare professionals that can improve the care they deliver to patients with AFib. If you have any questions or require additional information, please contact Cynthia Bens, Director of Public Policy at the Alliance for Aging Research at [email protected] or 202-293-2856.

Sincerely,
Alliance for Aging Research
Anticoagulation Forum
Atrial Fibrillation Association
ClotCare
Mended Hearts
Men’s Health Network
National Stroke Association
Preventive Cardiovascular Nurses Association
Society for Women’s Health Research
StopAfib.org

1 Benjamin, E, P Wolf, R D’Agostino, H Silbershatz, W Kannel, and D Levy. 1998. Impact of atrial fibrillation on the risk of death: The Framingham Heart Study. Circ 98(10):946-52.
2 Go, AS, EM Hylek, KA Phillips, Y Chang, LE Henault, JV Selby, and DE Singer. 2001. Prevalence of Diagnosed Atrial Fibrillation in Adults: National implications for rhythm management and stroke prevention—the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA. 285(18):2370-5.
3 Go, AS, EM Hylek, KA Phillips, Y Chang, LE Henault, JV Selby, and DE Singer. 2001. Prevalence of Diagnosed Atrial Fibrillation in Adults: National implications for rhythm management and stroke prevention—the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA. 285(18):2370-5.
4 Krass I, SJ Ogle, MJ Duguid, GM Shenfield, BV Bajorek. 2002. The impact of atrial fibrillation on antithrombotic use in elderly patients with non-valvular atrial fibrillation. Aust J Aging. 21(1):36-41. +