Despite the passage of health care reform legislation last week, Congress failed to approve a $138 billion bill to prevent a planned 21% cut in Medicare Part B reimbursements to physicians before entering its spring recess. The cuts are set to go into effect on Thursday, April 1st. Although the Senate earlier this month approved a measure to prevent the cuts from taking effect until October 1st, the House failed to pass the measure before Congress began an approximately two-week long recess that will delay a fix from being passed until at least mid-April.
The bill is the most recent in a series of yearly postponements in cuts to physician payments prescribed by the sustainable growth rate (SGR) formula. Developed to ensure that Medicare spending doesn't outpace growth in the economy, the SGR is an accounting mechanism which ties Medicare Part B reimbursement rates to the gross domestic product. The formula has called for large cuts in physician payments every year since 1997. However, successful annual lobbying efforts by the American Medical Association and other physician groups have persuaded Congress to postpone these cuts each year, arguing that reducing reimbursements would cause doctors to stop seeing Medicare patients, jeopardizing access to healthcare for millions of seniors and military families. Such cuts, they argue, would reduce payments to well below the cost of providing care.
Physicians have advocated for the repeal of the SGR method, rather than perpetual reliance upon Congress to take action each year. Negotiations on a permanent fix have been active since December, but an initial vote was taken to postpone the planned decreases from January 1st until April 1st to allow Congress more time to develop a permanent solution. However, with Congress now in recess, a vote by the House to further forestall the cuts beyond April 1st will not be possible until their return in mid April, without which the -21% decrease in reimbursement rates will take effect.
Congress' failure to act before the April 1st deadline may be partially attributable to the looming fate of the overall health care reform package, which some had feared might complicate the delicate political process involved with that bill's passage. Now unhampered by activity on that legislation, the House of Representatives is widely expected to pass their version of the Senate's postponement bill (which also includes provisions on extending COBRA and unemployment benefits) upon returning to Capitol Hill two weeks from now. While this will result in at least a brief period of temporarily reduced Medicare physician payments, it is likely that -- when passed -- the House bill will apply the postponement of rate decreases retroactively to April 1st, ensuring all claims filed between the 1st of April and the date the bill takes effect will be reimbursed at the pre-cut rates.
Among the studies presented at the Society of Interventional Radiology's (SIR) 35th annual scientific meeting last week, one lends an encouraging development in the use of interventional oncology therapies for prolonging the life of liver cancer patients and minimizing side effects associated with traditional treatments. The study, led by Dr. Riad Salem, director of interventional oncology at the Robert H. Lurie Comprehensive Cancer Center at Northwestern Memorial Hospital in Chicago, tested the use of intra-arterial yttrium-90 (Y-90) radioactive isotope therapy to deliver a high dose of radiation directly to liver tumors. When compared to traditional treatment methods, this use of Y-90 to deliver a higher dose of targeted radiation showed promise for prolonging life and decreasing adverse side effects experienced by liver cancer patients.
The study consisted of 291 hepatocellular carcinoma (HCC) liver cancer patients, each treated with an average course of 1.8 Y-90 microspheres. Microspheres were inserted through a catheter into the liver artery supplying each tumor. Each isotope then provided localized "internal radiation" within tumor vessels, spurring cell death. Researchers evaluated patient response to the treatment, as well as time-to-progression, and survival rates by different cancer stages.
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My colleague, Charlie Robinson, has been involved in a new terrain of reserach for our research group, looking at developments being made in stem cell research and their potential applications in medicine moving forward. He's been finding some particularly interesting topics and I wanted to share one in particular.
In February 2009, a German medical team may have cured a patient's HIV infection while treating his leukemia. The patient--a 42-year old American living in Germany--is still without signs of HIV infection two years after receiving a bone marrow stem cell transplant. Physicians deliberately chose a donor with a naturally occurring gene mutation that confers resistance to most types of HIV infection--a mutation known at CCR5--which is normally found on the surface of T cells, the type of immune system cells attacked by HIV.
Though physicians assert that stem cell transplants are not a feasible routine treatment option for HIV--explaining that about one third of patients die from such transplants--the findings are promising for the future of HIV therapy. A more reasonable approach based on these findings would be a type of CCR5-disabling gene therapy or treatment that could be injected directly into the body. Experts predict this type of treatment could be available within the next five years.
While the findings in this case represent a glimmer of hope for patients living with HIV, physicians note that it is unlikely that the transplant completely eradicated HIV from the patient's body. Moreover, German physicians who performed the transplant procedure admit, "There is no really conclusive explanation why [they] didn't observe any rebound of HIV. This finding is very surprising."
Yoqneam, Israel-based Given Imaging - manufacturer of gastroesophageal diagnostic devices - will bolster its portfolio in the coming weeks with the acquisition of Los Angeles, California-based Sierra Imaging. Sierra's product line includes ManoScan and PolyGraf ID, esophageal manometry tests designed to measure the pressure of muscle contractions inside the esophagus, and AccuTrac and Digitrapper, catheter-based acid reflux monitoring devices.
The global market for gastroesophageal diagnostics reached $60 million in 2009, and it is estimated that 20 percent of the population suffers from gastroesophageal reflux disease (GERD), or approximately 147 million people in the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.
Given Imaging, which manufactures the one-of-a-kind Bravo wireless pH monitoring system for GERD, stands to collect $20 million in revenue from the acquisition over the next 12 months. In addition to the potential financial benefits of the acquisition, incorporating Sierra Imaging's products into the Given product line will further cement Given's position as global leader in the gastroesophageal diagnostic market.
With what seems to be the worst of the economic downturn now behind us, we have been projecting outpatient imaging volume to begin to rebound this year, albeit slowly. But based upon our conversations with members, our colleagues in the Imaging Performance Partnership have not seen this happen, and in many cases, have seen quite the opposite with providers reporting decreases in volume, specifically CT and MRI. This begs the question, "What's happening to outpatient imaging volume?" I've provided some insightful comments from Shay Pratt, Managing Director of the Imaging Performance Partnership, as well as resources available to members to help assess and rebuild outpatient imaging volume.
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According to National Center for Health Statistics (NCHS) data on procedures performed in 2006, Cesarean section (C-section) is the most frequently performed surgical procedure in U.S. hospitals.
A related update was released last week when the NCHS published its most recent statistics on C-section rates in the U.S. The data--on births that occurred in 2007--reveal a C-section rate of 32 percent--and an absolute C-section incidence of 1.4 million procedures--the highest rate ever reported. This high follows an existing trend of rising C-section rates that began in 1996 following a period of decreasing rates in the early 1990s. Between 1996 and 2007, the C-section rate increased by 53 percent, from 21 percent of all births in 1996. The World Health Organization (WHO) recommends that C-sections should not exceed 10 to 15 percent of live births.
Nationally, the percentage of women undergoing C-section rose across all age cohorts and ethnic groups. Moreover, C-sections were increasingly prevalent in all gestational age groups, although C-section is more common among preterm births (less than 37 weeks) than term births (37 weeks and over). However, rates vary considerably among states, from 22.2 percent in Utah to 37.2 percent in Florida.
A variety of medical and non-medical explanations have been proposed for the rise in C-section prevalence, including advancing maternal age and an increase in multiple births (in part linked to increasing use of assisted reproductive technology (ART). However, surgical delivery is rising among women of all ages, not only older women, and the C-section rate for singleton births is growing more quickly than the rate for multiples. Although patient preference may affect treatment in some cases, physician practice patterns--based on clinical concerns about vaginal birth after C-section (VBAC), choosing to induce labor, and concerns about potential legal action in the case of an adverse outcome--have come to the fore as key drivers of C-sections.
At the same time, organizations are laying groundwork intended to improve obstetric (OB) care and decrease the C-section rate. The American Congress of Obstetrics and Gynecology (ACOG) has updated its guidelines on VBAC, noting that VBAC may be a viable option for many women, particularly those who had a low-transverse section. Additionally, the Institute for Healthcare Improvement (IHI) is studying practice bundles designed to improve perinatal care; one of these practices is prohibition of elective induction or scheduled C-section prior to 39 weeks gestational age. Institutions participating in the pilot of the perinatal bundles are reporting positive effects on patient outcomes, but these practices have yet to become widespread.
With increasing attention given towards CT radiation dose and the expansive growth of advanced imaging volume, clinicians and industry alike are both searching for means to make diagnostic imaging a safer, cheaper, and accessible service for patients without diminishing its important role in medicine. In this regard, ultrasound - a ubiquitous modality commonplace in all hospitals and capable of myriad applications - is experiencing a rebirth, and as vendors continue to innovate with ultrasound systems, the technology is becoming much more attractive as a highly functional modality not to be overlooked or undermined when planning for new imaging investments.
In recent years, advancements in computer processing capabilities, transducer configurations, and software applications have led to the resurgence of ultrasound as an advanced imaging modality, capable of acquiring very high quality diagnostic images that in some cases can rival other modalities like CT and MRI. Additionally, novel imaging modes are making ultrasound a more functionally diverse system, which have the potential to dramatically change traditional care pathways.
One such imaging mode is elastography, which is receiving considerable attention as a viable tool with the potential to change traditional care pathways for a variety of diseases, including breast cancer and chronic liver disease.
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Aritrech's Watchman, a percutaneous left atrial appendage (LAA) occlusion device, will require an additional study before getting approval for commercial use. Last week the FDA informed the company that a confirmatory study be conducted to further substantiate the safety and effectiveness of the technology.
As reported earlier in the Pipeline, the technology is designed to close off a small pouch connected to the left atrium where it is estimated 90 percent of blood clots are formed in patients with atrial fibrillation (AF). A successful implantation of the device may allow AF patients to come off warfarin (Coumadin), an anticoagulant commonly used for patients with AF but with noteworthy risks.
Coming out of the 2009 ACC scientific sessions, the Watchman seemed to have a great deal of momentum. At that time results of the Embolic Protection in Patients with Atrial Fibrillation (PROTECT-AF) were first presented and showed that in AF patients, the Watchman device was associated with a reduction in hemorrhagic stroke relative to warfarin, and all-cause stroke and all-cause mortality outcomes were noninferior to warfarin. Shortly thereafter, an FDA advisory panel voted to recommend approval. That recommendation, however, came from a mixed panel, with 5 out of 7 not recommending the device be approved. The device's mixed reception foreshadowed its present fate.
An additional study will likely be shorter and smaller than the PROTECT-AF (which included 800 patients from 59 enrolling centers in the US and Europe), but it will still take time to collaborate with the FDA and complete enrollment and follow-up. To that end it could still be a year or two before commercial release becomes a reality.