Let the Budget Season Begin

by David May April 12, 2013 10:00

Everybody has a budget. Your family does, my practice does, your state has a budget, the ACC has a budget... and so does the country (at least some of the time). This week the president released his 2014 budget and I thought you might like to see some of the proposed provisions that impact cardiology and the practice of medicine as a whole.

Interestingly, there is an assumption that Medicare payments to physicians will not be reduced by the mandated Sustainable Growth Rate (SGR) formula.  This formula is scheduled to cut payments to physicians by 25 percent in 2014, but previous scheduled cuts have been overridden by short-term Congressional action. Perhaps it’s time to just fix it already!

There is also a proposal to reduce payments for the so-called “indirect” costs of graduate medical education (GME) by 10 percent starting in 2014, at a savings of more than $10 billion over 10 years. This is an increasingly important topic that the ACC’s legislative team is following closely.

While it’s important to note that this budget proposal is likely to be dead on arrival given the divided Congress and president, imaging is another area that “we” (the collective ACC) will also be keeping close tabs on this year. The budget proposal includes a provision to mandate prior authorization of advanced imaging (CT, MR, nuclear), as well as a proposal to limit the availability of the in-office ancillary services exception so that advanced imaging services (CT, MR, nuclear) could not be provided if ordered by a physician in that office. (The budget proposal does indicate that the exception could still be available if certain undefined accountability standards are met. But….)

On the brighter side, the budget proposal does contain provisions to increase funding for the FDA, partially by taking advantage of user fee programs authorized last year, previously existing programs for prescription drugs and medical devices, along with the new programs for biosimilars and generic drugs. Also $534 million in user fees are aimed at decreasing use of tobacco products. The National Institutes of Health also gets a small 1.5 percent bump from 2012 levels, for a total of $31 billion. The administration also includes funding for continued investment in health IT implementation and electronic information exchanges, given that current funds from the American Recovery and Reinvestment Act are beginning to expire.

Other proposals include a provision to lower the target growth rate for the Independent Payment Advisory Board so that the board could take binding action even with lower cost growth in health care.  Target growth rate would reduce to GDP plus 0.5 percent.  The IPAB, a major feature of the ACA, has yet to be formed. The budget would also extend funding for a consensus-based entity (likely the National Quality Forum) to focus on performance measures and quality improvement.  Current government funding for NQF expires at the end of 2014.

As I mentioned before, many of the items contained in the budget are unlikely to come to fruition due to the divided Congress and president. However the proposal provides a glimpse at administration priorities for next year. Perhaps we should all make sure to save the date for ACC’s Legislative Conference this September!

What You Need to Know for Health Policy in 2013

by Administrator January 18, 2013 12:32

This post was authored by Jim Fasules, MD, FACC, senior vice president of Advocacy for the ACC.

Despite a rather recalcitrant Congress, last year saw very significant changes for health care and cardiology. After the swirling uncertainty surrounding the Affordable Care Act (ACA), the U.S. Supreme Court ruled the ACA, including its individual mandate, was constitutional. With the federal debate laid to rest, the action shifts to the states where for political and policy reasons a patchwork quilt of variability still leaves physicians, hospitals and patients perplexed on how to adapt to Medicaid expansion, the Exchanges and other insurance changes. Yet hidden in the rancor over the ACA were many challenges and changes effecting cardiology that the ACC tackled with a large degree of success.

For more than a decade, the sustainable growth rate (SGR) and the nearly 30 percent cuts associated with the flawed formula have threatened to impede improvements to the health care system and weaken the sustainability of practices nationwide. While a fight for permanent repeal of the SGR was unsuccessful, the last-minute “fiscal cliff” legislation delayed “the cliff” and its 27 percent cuts until 2014, at least restore a degree of financial security to physicians and ensure patients have continued access to quality care for 2013.

Besides helping achieve the SGR patch in the American Taxpayer Relief Act of 2012 (ATRA), the ACC team succeeded in helping cardiology in two other important ways.  First, last year saw an aggressive campaign waged to close the in-office ancillary services exception (IOASE), also known as the Stark exception that allows us to perform tests and imaging in our offices, mounted by radiology and others. Its inclusion in the ATRA was successfully prevented. In addition, the team’s work with the Senate Finance, Ways and Means and Energy and Commerce Committees, following the stellar testimony of ACC Past President Douglas Weaver, MD, MACC in July, resulted in the law providing that participation in qualified clinical data registries, such as the NCDR®, will count as PQRS participation in 2014. While many details still need to be worked out, this will allow greater ease of avoiding the cuts that now occur for non-participation in PQRS.

Despite our successes, 2013 has many risks. The 2 percent across-the-board sequestration cut to Medicare and the even greater cuts to public health remain a threat when the two month delay in the ATRA expires on March 1. The ACC adamantly opposes the 2 percent Medicare sequester and the approximately 8 percent sequester cut to NIH, CDC, AHRQ and other crucial agencies, and the College will continue to urge Congress to prevent the cuts from going into effect. While successfully prevented in 2012, the forces working to close the IOASE have already marshaled an even stronger campaign this year. In response, we are working with a broad coalition to demonstrate to Congress and the Administration that closure of the exception would cause great disruption to patient care and would effectively end the viability of private practice and actually result in greater expenses for Medicare and insurers. Similarly, the College remains opposed to enactment of prior authorization for imaging services under Medicare.

On the medical liability reform front for this year, the U.S. House of Representatives is expected to take action on the HEALTH Act once again, which includes MICRA-type liability reforms. The College will continue to work with other stakeholders to support this act and advance supplemental medical liability reforms. Often missed in the College’s activities is its work for public health and science.  Again this year, the College will work to support federal funding for NIH; AHRQ; the NHLBI; the Health Resources and Services Administration’s AED program; the Prevention and Public Health Fund; the Million Hearts™ initiative; CDC’s Heart Disease and Stroke Prevention Program; and congenital heart disease research and surveillance.  As Congress struggles to find spending cuts, Graduate Medical Education (GME) finds itself targeted.  Advocacy with the help of the Academic Council is working with the AAMC to prevent any disruption to fellowship training.

As you can see 2013 holds many risks to cardiovascular care.  There are many opportunities for U.S. members to get involved in ACC's advocacy efforts, including learning more about ACCPAC, and participating in legislator practice visits and Legislative Conference.

Stay tuned to CardioSource.org/Advocacy throughout the year for health policy updates. To get involved in ACCPAC, visit accpacweb.org.

Fiscal Cliff Crisis Averted and “Doc Fix” Patched for Another Year

by William Zoghbi January 4, 2013 10:05

Earlier this week the nation waited in anticipation as the American Taxpayer Relief Act of 2012 was passed through the Senate, and eventually through the House late New Year’s Day, therefore averting the so-called “fiscal cliff” from taking effect. The bipartisan deal included a one-year patch of the flawed Sustainable Growth Rate (SGR) formula, preventing Medicare payment cuts of 26.5 percent that were set to kick-in on Jan. 1. Across-the-board sequester cuts of 2 percent were also delayed, keeping Medicare reimbursement safe for another two months.

Throughout the past year, ACC leadership and staff helped lay the groundwork for several quality-related provisions in the new law through ongoing dialogue with congressional committees about ACC’s quality improvement tools, including registries. Included in the legislation, was an extension of the Geographic Work Adjustment through 2013 and reauthorization of funding for measure endorsement for another year. The ACC worked with the Stand for Quality coalition, including the National Quality Forum and the American Medical Association, to advocate for extension of this funding.

Also thanks to the incredible efforts of ACC’s Advocacy team, a provision to qualify registry programs to meet Physician Quality Reporting System (PQRS) reporting requirements was included. Professional society clinical data registries, such as the ACC’s National Cardiovascular Data Registry, collect robust data that are used to provide feedback to physicians and enhance performance. This focus on quality, evidence-based care by itself is an effective way to reduce overall costs while enhancing quality of care. Registry participation is a more robust performance improvement method than the current PQRS, and now that more physicians can meet PQRS requirements, physicians can avoid future penalties under the program. This provision was the result of discussions between ACC, the American Society of Clinical Oncology, the Society of Thoracic Surgeons, and a few other organizations with bipartisan staff for the Senate Finance Committee and House Ways and Means Committee in the summer and fall.

The College also played a key role in a provision to enhance the quality of data needed for new delivery and payment models. The law now requires the Secretary of HHS to develop a strategy to provide data for performance improvement to physicians in a timely manner. This provision is the direct result of testimony by physicians, including ACC Past President Doug Weaver, MD, MACC, before the Senate Finance Committee this summer as well, as a roundtable discussion between committee staff, ACC and several other specialties this fall.

While the offsets used to pay for the $25 billion SGR patch do result in an increase in the equipment utilization rate for advanced imaging modalities that is limited to CT/MR/PET, which will mean reduced payments, but fortunately ACC staff were able to keep prior authorization and changes to the in-office ancillary services exception kept out of the agreement.

Moving forward, ACC’s Senior Vice President Jim Fasules, MD, FACC, said it best when he told the ACC presidential team earlier this week  that while “the work now shifts to the spending cuts debate with a big spotlight on entitlements … right now we get to stop holding our breath.” It is now more important than ever that the cardiovascular community and the rest of the house of medicine build on the momentum from these efforts and continue to push for a permanent repeal of the SGR. As I mentioned in my blog post last week, 90 percent of ACC PAC-supported candidates (104) won their respective elections in November 2012, strengthening the College’s allies on Capitol Hill. These relationships and grassroots efforts have and will continue to be increasingly important as we work towards a permanent repeal over the next year. The ACC stands ready to work with Congress as it confronts the challenges and opportunities within Medicare.

Stay tuned to the ACC Advocate and CardioSource.org for additional details in the coming months.

 

Banding Together to Fix the Flawed Payment System

by Administrator December 14, 2012 04:20

This post is authored by Stephen R. Ramee, MD, FACC, chair-elect of the Interventional Scientific Council.

The 2013 Medicare Physician Fee Schedule continues the Centers for Medicare and Medicaid Services' (CMS) campaign to reduce payments for complex procedures and diagnostic tests in order to redirect resources to other services. An agenda that began with crippling cuts to echocardiography and SPECT and continued with implementation of faulty practice expense data that cut cardiology services across the board has now targeted EP procedures and PCI.  Although the cuts result in large measure from decreases in the amount of time needed to perform the typical EP study and ablation or PCI (note that the system for determining RVUs is heavily driven by procedure time), CMS payment policy decisions have made things worse. By unilaterally rejecting recommendations from the physician community that would provide opportunities for cardiologists to accurately report more complex procedures, CMS is preventing physicians who care for the most challenging patients from being fairly compensated. ACC will be vigorously opposing CMS’s decisions and working with the Society for Cardiovascular Angiography and Interventions (SCAI) and the Heart Rhythm Society (HRS) to rectify these decisions. Unfortunately, no changes to the fee schedule can happen before 2014.

Our practices that have already experienced precipitous cuts in payment for core services now face payment reductions on the order of 27 percent for EP studies/ablations and 20 percent for PCI. Many of us, myself included, are astonished that the reward for a relentless focus on quality that has brought about a 27-percent reduction in mortality from heart disease is a payment cut.

While the cardiovascular field is justifiably angry about the latest round of payment cuts, it’s important to recognize that this is the byproduct of a broken system for physician payment. Congress’s inability to fix the Sustainable Growth Rate (SGR) has meant a decline in real terms in the resources our nation devotes to paying for the physician services Medicare patients need and deserve. Rest assured that ACC will be doing everything possible to reverse CMS’s bad decisions and to stop the SGR cut from going into effect. But we will also be redoubling our efforts to make sure policymakers understand the value of the lifesaving work cardiologists do every day and to move toward a payment system that supports and rewards our specialty’s dedication to improving care and outcomes for patients with heart disease.

For full coverage of the 2013 fee schedule and coding changes, visit CardioSource.org/PhysicianPayment. Stay tuned to The ACC Advocate for updates on ACC’s action. Be sure to follow @Cardiology on Twitter for the latest advocacy and health policy news.

The Election is Over but Now What?

by Administrator December 13, 2012 08:41

This post was authored by Douglas Weaver, MD, MACC, past president of the ACC.

This year has been a painful one for healthcare providers due to the continued atmosphere of uncertainty.  Many of us began this year working on initiatives that deal with some of the changes attendant with the Affordable Care Act – e.g. reduce unnecessary admissions and change them to observation status, decrease readmissions for patients with a recent MI or for heart failure, and putting together means to provide better continuity of care.  Before the election, it was impossible to fully engage given the polarizing rhetoric between parties.  At the present time our payment policies don’t reward either physicians or hospitals for reducing readmissions, and rather we take a hit. 

However, even after the election, it still isn’t better. We are in an environment with continued partisan bickering about the legislation, lack of agreement on a common approach to sequestration, the tax cuts, unemployment benefit extension, reducing the deficit, how to pay for the SGR (and possibly with further Medicaid cuts, reduced NIH funding, loss of facility based E and M dollars, IME reductions).

After studying the issues and listening to the pundits, I have come to the following conclusions: first, our national debt is a major problem and one that needs to be fixed.  If you include the “promised entitlements” of Medicare and Social Security, it is close to 86 trillion dollars — and this number would require collecting 8 trillion dollars a year in taxes to just keep it from going higher. Congress can’t agree on ways to get a few hundred billion to balance the budget for the coming year. The total earnings of all of us filing tax returns is a little over 5 trillion dollars a year — and that is earnings not the taxes you and I currently pay.  Conclusion: we have to curb entitlements no matter what happens to taxes.

Second, people are spending less on healthcare. Visits are down, admissions are down—the cost curve has been bent already. If you count up the 50 million people in our country with no insurance, add 40 million who do, but who can’t pay their deductibles or co-pays, and the almost 55 million on Medicaid—this says that half the people in our country can’t afford our healthcare.  Conclusion: it is not about healthcare inflationary costs (these are now fixed), it is about the absolute cost.  Cost of healthcare in the U.S. is 1.5 to 2 times more expensive than elsewhere.  With peoples’ individual contributions increasing for care, they are voting with their feet and avoiding, when possible, doctor visits and procedures.

Lastly, there are some basic problems with the way we are approaching enacting “change.”  If all of our patients are going to pay more now for coverage and we are going to move to pay for quality, our patients should be getting something for this right up front—not years down the road.  Second, don’t harness the providers to the plain vanilla PQRS quality reporting measures and 18 month old administrative data to track performance. Instead, let specialty societies like the ACC, who can focus initiatives in areas where its members determine deserve improvement, and support these organizations to provide feedback and tools for improvement to their constituencies, instead of funding a larger, but less relevant reporting now done by the insurers.

We are adaptable—we can move more quickly and deliver more, but not at our own expense. We can however do so with a promised reduction in the overall cost of care and with equal or higher satisfaction from our patients.  

The CardioMetabolic Health Alliance: Improving Quality, Bending the Cost Curve

by Administrator October 9, 2012 10:05

This post is authored by Gary Puckrein, PhD, president and chief executive officer of the National Minority Quality Forum.

Physicians and the medical community have reached a fork in the road: we need to document that quality and reduced costs are related. By doing so, we hope to offer policymakers a new framework in which to measure the value of medicine. The conjectures:

  • An avoidable mortality index can be an indicator of unnecessary acute events (disease, hospitalizations, disability and death) in a population. Such an index may have utility in localizing the performance of our health care system, thus enabling the investigation of gaps in outcomes of care. 
  • There are signals that avoidable acute events are non-random occurrences. There is a possibility that they manifest at predictable frequencies within clinical and geographic sub-populations, and are sentinels of health care and health status disparities.
  • Unnecessary acute events have financial implications. At least one study found that 36% of diabetes-related hospitalizations were avoidable. If that percentage holds true for Medicare beneficiaries, the savings could well be over $10 billion per year.
  • By reducing unnecessary acute events, we may be able to establish an association between improved quality and bending the cost curve, thereby offering a counterpoint to those who believe reducing provider reimbursements is a desirable cost savings device.


The American College of Cardiology, the National Minority Quality Forum (NMQF), and the American Association of Clinical Endocrinologists have joined forces to put our conjectures to the test and have formed the CardioMetabolic Health Alliance. The objective of the Alliance is to improve cardiometabolic risk factor control in diverse populations, including high blood pressure, elevated fasting blood sugar, dyslipidemia, abdominal obesity (waist circumference) and elevated triglycerides; and to provide more effective and coordinated care for people with established cardiometabolic disorders.

In pursuit of its mission, the Alliance will study the possibility that predictable patterns of unnecessary acute cardiac events occur in communities, and that these patterns are measurable and amenable within the context of current treatment modalities. By using the ACC’s PINNACLE Registry and CathPCI Registry, as well as NMQF’s Cardiovascular Disease Index and U.S. Diabetes Index, the Alliance will explore the possible correlation between cardiometabolic disease and unnecessary emergency room visits and hospitalizations; and how these findings can be used to design predictive models and quality improvement interventions targeted for providers and patients at high risk for an acute cardiovascular episode.

Members of the CardioMetabolic Health Alliance and ACC will be meeting at the 2012 Cardiometabolic Health Congress this week in Boston, Ma. Visit the Alliance’s website for more information www.cardiometabolicha.org. Also read more about CardioMetabolic Syndrome in an article in the July/August issue of Cardiology magazine.

What do Cardiologists and Football Have in Common?

by Dipti Itchhaporia September 10, 2012 07:02

One might not initially think that cardiologists and football players have a lot in common. However, coming out of the standing-room-only Board of Governors (BOG) meeting this past weekend, I can tell you that the team spirit and tireless work ethic of ACC’s cardiovascular “team” rivals that of the best players on the football field.

The September BOG Meeting is always one of my favorites. We’re moved beyond saying “here’s what we’re going to do” to “here’s what we’re doing.” It’s a time to look back on early accomplishments, reassess priorities if needed, and celebrate where we’re going.

Among the early accomplishments this year:

  • A formal recommendation regarding Appropriate Use Criteria terminology. The BOG has been an integral part of these discussions over the last several months and   we believe that the recommended changes will address many of the concerns raised by members at the grassroots level, particularly regarding the use of the term “Inappropriate.”
  • The development of a Digital Strategy. No, the BOG is not responsible for developing the Digital Strategy, but many governors have been involved in some manner in its development, whether it’s sharing feedback from Chapter members, actively taking part in usability testing or simply using the College’s online and mobile resources.
  • Participation in the Million Hearts initiative. We heard from Janet Wright, MD, FACC, executive director of Million Hearts, that the College and its Chapters are among the biggest contributors to Million Heart activities. As the initiative enters its second year, even more opportunities for involvement are expected.

Looking ahead, the College’s new Lifelong Learning Portfolio offers unprecedented new learning opportunities for ACC members. There are also incredible new quality improvement tools in development or newly launched that are intended to help cardiovascular professionals not only adhere to guidelines and best practices, but also involve patients in their care. Among these resources: Clinical Toolkits for atrial fibrillation and heart failure, and growing opportunities to use Imaging in FOCUS tools in practice. New CardioSmart initiatives like CardioSmartTV, which puts patient-themed content on waiting room televisions, offer up unique new ways to reach patients. As Dr. Wright also mentioned, we still have four more years to reach the Million Hearts goal of preventing one million heart attacks and strokes.

Of course, I’d be remiss not to mention some of the health policy issues ahead. There is no doubt that health reform implementation will continue to have impacts on the current practice environment, as will continued cuts to Medicare physician payment. There is a need for the entire cardiac care team to come together as one voice to make sure that policies moving forward are in the best interest of our patients. Issues like public reporting, the Physician Payment Sunshine Act and other policies being discussed will have profound impacts on how we practice and it’s important that the College and its members be heard.

This weekend reinforced that the ACC’s BOG is comprised of an amazing team of men and women who selflessly volunteer their time in many different ways, with the ultimate end goal of ensuring patients living with, or at risk of, heart disease are receiving the best, most appropriate care possible. Like the football teams who took to the field this weekend, we will take some hits and might even lose a few yards, but at the end of the day there’s a sense of accomplishment for all the yards run and the touchdowns that were made. As the old saying goes, we “come together, share together, work together and succeed together.”

 

Another Love Affair is Over

by Administrator August 30, 2012 04:09

This post was authored by Kathy Blake, MD, FACC, member of the ACC’s Advocacy Steering Committee.

A recent article in the Wall Street Journal, “Same Doctor Visit, Double the Cost” (subscription required) detailed the shift we have seen across the country of hospital systems acquiring private practices, often leading to higher prices of services.
The article notes that “as physicians are subsumed into hospital systems, they can get paid for services at the systems’ rates, which are typically more generous than what insurers pay independent doctors. What’s more, some services that physicians previously performed at independent facilities, such as imaging scans, may start to be billed as hospital outpatient procedures, sometimes more than doubling the cost. The result is that the same service, even sometimes provided in the same location, can cost more once a practice signs on with a hospital.”

The article lays the groundwork for much of what the College has been advocating for over the past few years: the need for payment reform. The payers have noticed. The patients have noticed. The Centers for Medicare & Medicaid Services (CMS), as the article suggests, may have its hands (somewhat) tied by statute. The love affair with independent practice ended a long time ago. The infatuation of business with private payers and HMOs died awhile back. The current love affair, with integrated systems, is looking a bit tattered. The reality suggests that a variety of offerings across the full spectrum probably leads to a healthier delivery ecosystem, especially if there is transparency about cost and quality, and real competition based on accurate determination of value.

The article is timely as the 2012 Legislative Conference is right around the corner and will be touching on issues such as the College’s ongoing payment reform efforts, including advocating for the repeal of the sustainable growth rate (SGR) and instead focusing on quality-based delivery and payment models. Also at Legislative Conference Dr. Zoghbi will give an update on the “State of Cardiology” with results from this year’s Practice Census (we remember the results from two years ago that started documenting this shift in private practice).

The current fee-for-service system in integrated models is not sustainable, and it is up to us to steer the payment reform decisions in the right direction.

Dr. Weaver Goes to Washington

by Administrator July 13, 2012 11:51

This post was authored by ACC Past President W. Douglas Weaver, MD, MACC.

Wednesday was an exciting day in Washington, DC, where I testified on behalf of the ACC before the Senate Finance Committee hearing regarding Medicare physician payments. The hearing addressed problems plaguing the current Medicare physician payment system and sought to identify new payment models and quality initiatives that incentivize high-quality and high-value care at reduced costs.

Following recent discussions with former Centers for Medicare and Medicaid (CMS) administrators and insurers, the ACC, along with the American Medical Association, American Academy of Family Physicians, American College of Surgeons and American Society of Clinical Oncology, was invited to share lessons learned on effective physician payment approaches. This was a vital opportunity to reiterate our long-term dedication to exploring innovative payment models in Medicare and share how our many quality programs and evidence-based measures are working to improve the delivery of high quality, affordable care.

I cannot stress enough how critical the discussion on Medicare physician payment is to the sustainability of our health care system. Congress must avert scheduled reimbursement cuts just released in the proposed 2013 Medicare Physician Fee Schedule, repeal the SGR, and provide stable payments for several years to allow the development of new delivery and payment models. They know this, but just don’t know how to do it. Although I was prepared to provide suggestions to improving value over the next several years; I was surprised to be asked about what we can do this year which will dramatically reduce Medicare costs beginning in January.

The SGR has been a problem for years and a key issue I faced during my tenure as ACC President in 2008. The current uncertainty in the future stifle both our practices and our hospitals in making real investments aimed at improving integration and reducing the current fragmentation of care and reducing waste. It is discouraging that Congress has yet to come up with a solution, but I am hopeful that we can develop a system that aligns compensation with performance of evidence-based medicine and higher value, appropriate health care.

During my testimony, I had the opportunity to discuss several of the College's exciting innovations currently underway, such as our clinical registries which can be used to increase quality far beyond the PQRS quality measures of CMS. We also have appropriate use criteria embedded into Cath PCI-which has begun to lower the number of patients getting unneeded revascularization.  I asked them to incent doctors to use these tools and incent EMR venders to incorporate them into their products which also need to be made interoperable among all of the suppliers.

I also told them they need to support care management in the out-patient setting, which is paying primary care docs and specialties such has ours in which the vast majority of our patients are billed under primary care diagnoses (eg, heart failure, coronary disease, hypertension). These extra dollars allow us to fund the needed physician infrastructure to keep these patients on a care plan, and to reduce emergency visits and hospitalization.

The bottom line is that ACC knows how to improve quality and efficiency use our registries and other specialty specific tools. If Medicare promotes these activities by incentivizing their use and helping pay for the efforts, I believe the current improvements that we are witnessing will accelerate.

Read more about the ACC's involvement in the Senate Finance Committee roundtable on Medicare Physician Payments on CardioSource.org including the submitted testimony. Also read a statement from ACC President William Zoghbi, MD, FACC on the hearing.

(pictured top: Dr. Weaver testifying before the Senate Finance Committee; pictured bottom: Senator Max Baucus (D-Mont.) and Dr. Weaver)

A Milestone and Victory for the Heart Team Approach and Patients

by William Zoghbi May 2, 2012 04:33

Yesterday was a big day for Transcatheter Aortic Valve Replacement (TAVR) therapy in the U.S. The Centers for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of TAVR. The announcement follows an analysis based on an NCD request from the ACC and The Society of Thoracic Surgeons (STS) in late 2011.

The NCD covers TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it permits Medicare coverage only in facilities meeting certain requirements. The NCD also requires all patients to be included in a national TAVR registry. Medicare coverage will be available for non-FDA-approved indications when performed in a CMS-approved clinical study.

In a statement, the ACC commended CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis. We also agree with CMS’s decision to structure the NCD in a manner that supports access to TAVR while ensuring that services are performed by the best qualified team of physicians and hospitals. We hope this NCD proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.

Earlier in the day, I also participated in an STS/ACC joint Town Hall meeting to discuss the ASCERT study which was presented at ACC.12 (read a previous blog post on the study here and listen to a recording of the town hall meeting here). Although the study has caused some controversy, all of the panelists, which included Dr. Jeff Rich, president of STS, Drs. William Weintraub and Fred Edwards (principal investigators) and others,  underscored the importance of the heart team approach to shared decision making with patients and transparent discussions to determine which revascularization procedure is best suited for a particular patient with multivessel coronary artery disease.

This same “heart team” approach has been apparent throughout the introduction of TAVR into the U.S. Over the past year, the ACC has worked with STS, SCAI and other professional societies on several clinical documents and recommendations in order to effectively and appropriately introduce this new therapy. In addition, the STS/ACC TVT Registry was developed as a collaboration between STS and ACC, also working with CMS, the Food and Drug Administration, Edwards Lifesciences and others.

It is gratifying to see this “heart team” approach starting to take hold. Congratulations to all involved in making this a reality; a victory for our patients.

For more TAVR news and updates and links to additional clinical documents, visit CardioSource.org/TVT.

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About the Authors

The ACC in Touch Blog is primarily co-authored by current ACC President John Gordon Harold, MD, MACC, and Board of Governors Chair David May, MD, PhD, FACC.

Harold John Gordon Harold, MD, MACC, became ACC president in March 2013. Dr. Harold is a clinical professor of Medicine at the Cedars-Sinai Heart Institute in Los Angeles.

May David May, MD, PhD, FACC, began as the chair of the Board of Governors in March 2013. Dr. May currently works as a managing partner at his private practice, Cardiovascular Specialists, PA (CVS) in Lewisville, Texas.

Learn more about Drs. Harold and May.

Statements or opinions expressed on the Blog reflect the views of the contributor, and do not reflect the official views of the ACC, unless otherwise noted.

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