The DOJ investigation: Lessons from Colleagues April 13, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy.Tags: Department of Justice, ICD, Implantable Cardioverter Defibrillator, Medicare claims
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I read with great interest a special article in the Journal of the American College of Cardiology by two electrophysiologists involved in a Department of Justice (DOJ) civil investigation. The investigation is related to implantable cardioverter-defibrillator (ICD) implant procedures performed on Medicare beneficiaries that appeared to fall outside of the approved indications outlined in a Centers for Medicare and Medicaid Services’ (CMS) National Coverage Determination (NCD). (more…)
Bill Requiring Unique Device Identifier Introduced in Senate April 1, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Cardiac Rhythm Management, Health Policy.Tags: FDA, medical devices, S.2193, U.S. Food and Drug Administration
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On Friday, March 16, bill S. 2193, “Ensuring Safe Medical Devices for Patients,” was introduced in the Senate by Senator Jeff Merkley (D-OR) with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI).
S.2193 is a bipartisan initiative that aims to strengthen and improve the oversight of medical devices. The bill requires the U.S. Food and Drug Administration (FDA) to issue a Unique Device Identifier (UDI) final rule by the end of the year. This rule is long overdue. (more…)
Review: 1st Alliance of Specialty Medicine Physician Health Policy Roundtable March 29, 2012
Posted by Andrea M. Russo, MD, FACC, FHRS in Allied Health Professionals, EP Physicians, Health Policy.Tags: Affordable Care Act, Health care
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Last Thursday could have been spent marveling at the breathtaking architecture of the US Capitol Visitors Center. However, the purpose of my visit to Washington, DC was not that of a tourist. Rather, I was a representing the Heart Rhythm Society (HRS) at the Alliance of Specialty Medicine’s Physician Policy Roundtable, which featured speakers on some of the most timely topics facing electrophysiologists. (more…)
The Independent Payment Advisory Board — What Next? March 21, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy.Tags: Healthcare Reform Act, Independent Payment Advisory Board, IPAB
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Last week, David Penson, MD, representing the American Urological Association (AUA), testified before the House Committee on Ways and Means Health Subcommittee, and called on Congress to repeal the Independent Payment Advisory Board (IPAB).
The Heart Rhythm Society (HRS), as a member of the Alliance of Specialty Medicine alongside AUA, has opposed the creation of the IPAB since it was first suggested, and has advocated for its repeal since the enactment of the health care reform law. The Society recently joined the IPAB Coalition in order to work with more organizations calling for the same action. (more…)
Meaningful Use Stage 2: Relevance to the EP March 15, 2012
Posted by David Scher, MD, FHRS in Allied Health Professionals, EP Physicians, Health Policy.Tags: Electronic Health Records, Healthcare reform, Practice management
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My eyes all but glazed over during a comprehensive read of the Centers for Medicare and Medicaid Services’ (CMS) Electronic Health Record (EHR) Incentive Program – Stage 2 Proposed Rule. It outlines updated objectives and measures that EPs and other health care providers will need to meet in order to be deemed “meaningful users,” so that they continue to earn toward the $44,000 mark in financial incentives.
As usual, the regulation was long…and complicated. Nonetheless, I have deciphered some good news from the rule that I am excited to share! Ok, so perhaps “excited” is a stronger than necessary reference. (more…)
Support HRS’ Advocacy Efforts- Participate in the Virtual Fly-in February 23, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Atrial Fibrillation (AF), Health Policy.Tags: AF Resolution, Afib, American Heart Month, Atrial fibrillation, Members of Congress
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The Heart Rhythm Society, in collaboration with other stakeholders, is educating Members of Congress, their staff and the public about heart rhythm disorders. During the American Heart Month, HRS is organizing a virtual fly-in on February 23. We ask HRS members and non-members to email their House Representatives and urge them to co-sponsor the AF Resolution (H. Res. 295). (more…)
Courage May Be The Solution February 18, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy.Tags: Congressional hearing, Healthcare, Medicare, Physician Payment System, Quality & outcomes
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Last week, the Ways and Means Committee of the House of the Representatives held a congressional hearing to examine programs that reward physicians for delivering high quality and efficient care. Health insurers and physicians spoke about their individual efforts to improve quality and efficiency: insurers through new payment models and financial incentives, and physicians through practice transformations. (more…)
Five Reasons Why Patients with Implantable Defibrillators Deserve Their Data February 17, 2012
Posted by David Scher, MD, FHRS in Allied Health Professionals, EP Physicians, Health Policy, Industry.Tags: Arrhythmia, Electronic Health Records, HEREHR, HITECH Act, ICD, Implantable Cardioverter Defibrillator, pacemaker
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The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, was signed into law on February 17, 2009. The objective of Measure 12/15 of Meaningful Use regulations of the HITECH Act, which refers to electronic health records, states that eligible professionals “Provide patients with an electronic copy of their health information (including diagnostic test results, problem lists, medication lists, medication allergies) upon request.”
A patient’s implantable defibrillator consists of a diagnostic test of the patient’s rhythm as well as of the implanted device itself. I do not see a distinction between data derived from these devices and other diagnostic tests. In this post I will explain why, in addition to conforming to the above regulatory requirement, the furnishing of this data will benefit patients. (more…)
GAO Report Finds Lack of Transparency in Implantable Medical Device Prices February 14, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy, Industry.Tags: GAO, Government Accountability Office, ICD, Implantable Cardioverter Defibrillator, Medicare
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In response to a request from Max Baucus (D-MT), Chairman of the powerful U.S. Senate Finance Committee, on February 3 the Government Accountability Office (GAO) released a report outlining the difference in prices that hospitals pay for implantable medical devices (e.g. defibrillators and hip replacements). (more…)
FDA User Fee Bills: Why You Should Care February 13, 2012
Posted by Kathleen Blake, MD, MPH, FHRS in Health Policy.Tags: FDA, Patient Protection and Affordable Care Act, PPACA, U.S. Food and Drug Administration, UFA, User Fee Act
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The U.S. Food and Drug Administration (FDA) relies upon user fees from manufacturers in order to perform product reviews in a timely fashion. The statutes that authorize collection of these fees are reauthorized every five years. The Medical Device User Fee Act (MDUFA) is up for reauthorization no later than September 30, 2012. The FDA has been actively engaged in discussions with manufacturers in anticipation of renewal. An article this week suggests that an agreement has been reached between the FDA and the device manufacturers that will increase the total fees paid over five years to FDA from $295M to an estimated $595M. The fees collected will allow the FDA to hire more evaluation staff during the term of the renewal. Although Members of Congress seem to agree on very little of late, renewal is expected by all parties because the FDA and the manufacturers both depend on the fees allowed by the Act to get products reviewed and approved. (more…)
Heart Rhythm Society
Laurie Racenet, RN, MSN, ANP
Michael Giudici, MD, FACC, FACP, FHRS
Heather M. Ross, DNP, ANP-BC, CCDS, CEPS, FHRS
Anne Dubin, MD, FHRS
John D. Day, MD, FHRS
Andrea M. Russo, MD, FACC, FHRS
Joshua M. Cooper, MD, FACC
Amit J. Shanker, MD, FHRS, FACC
Bruce Stambler, MD
David Wiggins, RN, BS BME, CEPS
Fred M. Kusumoto, MD, FHRS
Leonard Ganz, MD, FHRS
christinechiuman
Craig Delaughter, MD, PhD
Ariana Del Negro, Heart Rhythm 2010 Quality
Peng-Sheng Chen, MD, FHRS
MSKremers MD,FHRS
Ann C. Garlitski, MD, FACC, FHRS
Alan Cheng, MD, FHRS
Ulrika Birgersdotter-Green, MD
Christopher Clyne, MD, FHRS
Kathleen Blake, MD, MPH, FHRS
David Scher, MD, FHRS
Sanjay Deshpande, MD, FHRS
Thomas F. Deering, MD, FHRS
