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MedPAC Revisits Open Payments; Considers Expanding Reporting Requirements
Discussion 9-11 Slides of MedPac Open Payments Presentation MedPac Commission Members          
Source: Policy and Medicine - September 16, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

ABIM and ACCME Announce Collaboration in Support of Physician Lifelong Learning
  On August 12, the American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) announced a collaboration to support physicians who are engaged in lifelong learning by enabling them to use those activities to satisfy requirements for ABIM’s Maintenance of Certification (MOC) program. “This collaboration will expand the options available to physicians to receive MOC credit and will enable continuing medical education (CME) providers to offer more lifelong learning options with MOC credit to internists and subspecialists,” according to a new press releas...
Source: Policy and Medicine - August 14, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

The Unintended Consequences of Public Reporting
     ProPublica Surgeon Scorecard Ad A major concern surrounding ProPublica’s recently released “Surgeon Scorecard” is that rating physicians in a public database solely on complication rates may discourage surgeons from operating on high-risk patients. The fear, it turns out, is a legitimate one. A study published this month in the Journal of the American College of Cardiology examined the effect that public reporting of procedural outcomes has on heart attack patients. The authors looked at two states, Massachusetts and New York, which mandate the public reporting of hospital outcomes of per...
Source: Policy and Medicine - August 12, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

CMS Releases 2013 Medicare Payment Data for Hospitals and Physicians
  Yesterday, the Centers for Medicare and Medicaid Services (CMS) announced the release of utilization and payment data for both Medicare hospital services (inpatient and outpatient) and for physicians and suppliers. This is the third year the hospital data was released and the second year that the physician and supplier data was released. Indeed, the big troves of healthcare data keep coming. On April 30, CMS published information on 2013 Medicare Part D payments. At the end of this month, on June 30, CMS is scheduled to release the first full year of pharmaceutical and medical device trans...
Source: Policy and Medicine - June 2, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

"Reconnecting the Dots — Reinterpreting Industry–Physician Relations" Provides A Balanced Look At Physician-Industry Collaboration and Conflicts of Interest
Lisa Rosenbaum, MD recently published an article entitled “Reconnecting the Dots—Reinterpreting Industry-Physician Relations,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions between physician-scientists and industry at the basic or translational research level are equally clear,” she states. “The question, then, is how to best manage conflicts of interest while preserv...
Source: Policy and Medicine - May 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

MOC Controversy Continues, As Newsweek Unveils ABIM’s Troubled Financials
Newsweek writer Kurt Eichenwald last month wrote an op-ed entitled “The Ugly Civil War in American Medicine,” in which the author derided the American Board of Internal Medicine’s (ABIM) certification process for doctors. The author accused the ABIM of requiring unnecessary testing requirements “to fatten the board’s bloated coffers.” The ABIM quickly fired back that the Newsweek article contained "numerous and serious misstatements, selective omissions, inaccurate information and erroneous reporting.” They also accused Eichenwald of being biased because his wife was an internist, and condemned Ne...
Source: Policy and Medicine - April 17, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Spring Regulation Issue: Oil, Obamacare and Tech Innovation
Peter Van Doren This week, Cato released the Spring issue of Regulation. The cover article, by economist Pierre Lemieux, argues that the recent oil price decline is at least partly the result of increased supply from the extraction of shale oil.  The increased supply allows the economy to produce more goods. This benefits some people, if not all of them.  Thus, contrary to some commentary in the press, cheaper oil prices cannot harm the economy as a whole. A related article examines the dramatic increase in crude oil transported by trains and whether additional safety regulation of tank car design should be enacted.  E...
Source: Cato-at-liberty - March 25, 2015 Category: American Health Authors: Peter Van Doren Source Type: blogs

Maintenance of Certification Debate Goes Mainstream
Last week, Newsweek published an article entitled “The Ugly Civil War in American Medicine,” in which the author derided the American Board of Internal Medicine’s (ABIM) certification process for doctors. The author accused the ABIM of requiring unnecessary testing requirements “to fatten the board’s bloated coffers.” The ABIM quickly fired back that the Newsweek article contained "numerous and serious misstatements, selective omissions, inaccurate information and erroneous reporting.” Newsweek writer Kurt Eichenwald framed the problem like this: For decades, doctors took one exam, usually just after finishin...
Source: Policy and Medicine - March 20, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

FDA Device Guidance: General Wellness: Policy for Low Risk Devices
This article walks through the general wellness guidance, in which FDA provides many examples of devices they consider to be low risk general wellness products. The guidance, which spends a lot of time on general health and fitness mobile apps, makes clear FDA does not intend to regulate such products. Products classified as “medical devices” either need to be approved by FDA through pre-market approval or show that they are substantially equivalent to an existing device. Both processes take time and resources, so avoiding the designation is in a company’s best interest. Thus, FDA’s guidance on whether a product is...
Source: Policy and Medicine - January 29, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

FDA Device Guidance: Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types
This article walks through the accessory guidance, in which FDA clarifies that medical device accessories will not automatically take on the classification (Class I, II, or III) of the “parent device.” The agency will regulate based on the risks that individual accessories present when used with their parent device, and not based on the risks of the parent device. As a background, in the U.S., medical devices are divided into three categories. Class 1 (low risk): includes, for example, examination gloves, elastic bandages, tongue depressors, hand-held surgical instruments. Most do not require FDA approval, but manufac...
Source: Policy and Medicine - January 29, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Duke Cardiologist Robert Califf Named FDA Deputy Commissioner
FDA Commissioner Margaret A. Hamburg, M.D., on Tuesday appointed Robert Califf, M.D., a recognized global leader in cardiology and clinical research, as FDA Deputy Commissioner for Medical Products and Tobacco. In this position, Dr. Califf will be in charge of FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner. “Dr. Califf will play a critical role in providing high-level advice and policy di...
Source: Policy and Medicine - January 28, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Physician Specialty Silos Can Cause Friendly Fire Casualties
It’s no secret that medicine has become a highly specialized business. While generalists used to be in charge of most patient care 50 years ago, we have now splintered into extraordinarily granular specialties. Each organ system has its own specialty (e.g. gastroenterology, cardiology), and now parts of systems have their own experts (hepatologists, cardiac electrophysiologists)  Even ophthalmologists have subspecialized into groups based on the part of the eye that they treat (retina specialists, neuro-ophthalmologists)! This all comes as a response to the exponential increase in information and technology, making ...
Source: Better Health - January 13, 2015 Category: American Health Authors: Dr. Val Jones Tags: Health Policy Opinion Cardiology CMS Eric Topol Inpatient Rehabilitation NPR Patient Care Silos Smartphones Technology Thought Leaders Source Type: blogs

PhRMA and DOJ Go Back and Forth Over Off-Label Speech and the First Amendment
A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the Pharmaceutical Research and Manufacturers of America (PhRMA) and subsequently the Department of Justice, both of whom have filed amicus curiae briefs in the federal court. PhRMA re-responded to DOJ just last week, underscoring the case's importance. See that response here: PhRMA-Brief-Solis-v-Millennium.  Whistleblower Complaint Frank Solis, a former sales rep at Schering-Plough (now part of Merck) and Millennium Pharmaceuticals, alleged that the two manufacturers illegally marketed ...
Source: Policy and Medicine - September 17, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs

ACO Update: What Challenges Lie Ahead?
In June, we noted that Accountable Care Organizations (ACOs) have proliferated throughout the United States in the past few years, but they are still a comparatively new model for delivering low-cost, high quality care. As of mid-2013, there were over 4 million beneficiaries covered by Medicare ACOs. Additionally, a report identified 537 ACOs, and found that the number of physicians, nurse practitioners, and physician assistants participating in ACOs exceeds 190,000. Currently, there are nearly 289,000 total healthcare providers and business personnel aligned with ACOs. Despite these growing numbers, two interesting articl...
Source: Policy and Medicine - September 16, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs

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