Stories from the dialysis comunity across the globe.
The Sunshine Act puts physicians in the spotlight - NephrologyNews.com
BALTIMORE––If you accept payments from manufacturers or pharmaceutical companies, that information will be shared with the public, thanks to the Sunshine Act.
The law was built into the Patient Protection and Affordable Care Act that was released in 2010. It is part of a broader trend toward payers wanting to see more transparency of the interaction between physicians and industry. It follows the release of Medicare claims data showing how much Medicare pays physicians for various services.
Lauren K. Roth, assistant general counsel for the industry group PhRMA, presented information on the Sunshine Act at the Renal Physicians Association's annual conference here. She said the Act uses “broadly defined” wording to constitute what might be considered a payment between a physician and a company.
The Sunshine Act requires “applicable manufacturers” and “group purchasing organizations” to report to the Federal government any “payments or transfers of value” made to “covered recipients” (i.e., physicians and teaching hospitals).
Applicable manufacturers are entities that operate in the United States and either 1) produce at least one “covered product” (basically, any prescription drug, device, biological or medical supply that is eligible for payment by Medicare, Medicaid, or CHIP), or 2) operate under common ownership with a manufacturer and provide assistance or support in the manufacture, marketing, promotion, sale or distribution of a covered product, explained Roth.
Payment or transfer of value means “a transfer of anything of value,” although there are a few exclusions. Manufacturers must associate reportable payments with one of the following “nature of payment” categories:Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program
Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program
Current or prospective ownership or investment interests
Space rental or facility fees (teaching hospital only)
Consulting fees
Honoraria
Gifts
Entertainment
Food and beverages
Travel and lodging
Education [including reprints]
Research
Charitable contributions
Royalties or licenses
Grants
Reprints of articles, for example, that are provided to physician offices could be considered an open payment. If you are running for political office, and a pharmaceutical company donates to your campaign, that is considered a payment.
The CMS Open Payments website includes the first reporting period from August-December 2013, covering 546 physicians. Future reports are due to be published every year in June and will include a full 12 months of payment data from the previous year. March 31 is the deadline each year for manufacturers to submit information on open payments to physicians.
In the initial report, open payments varied widely; the lowest was $483.53, while the highest was $2.4 million paid to a physician from a medical device manufacturer.
Visit the CMS open payments website at http://www.cms.gov/openpayments/
Renal Research Institute Fellow Receives International Society of Nephrology ... - MarketWatch
NEW YORK CITY, Mar 25, 2015 (BUSINESS WIRE) -- Renal Research Institute (RRI), a division of Fresenius Medical Care North America, announced today that judges at the International Society of Nephrology’s (ISN) World Congress of Nephrology (WCN) in Cape Town, South Africa, have awarded RRI Research Fellow Dr. Viviane Calice-Silva the ISN’s Fellowship Poster 3rd prize.
Dr. Calice-Silva’s submission is entitled Multinational study of the relationship between fluid status and left ventricular structure and function in chronic hemodialysis patients. It presents the relationship between indicators of cardiac structure and function, determined by renal patients‘echocardiography and its relationship with fluid status assessed by the Body Composition Monitor (BCM), Fresenius Medical Care Germany. Renal patients who were included in this study are from 11 countries. While some of Dr. Calice-Silva’s results concur with observations in the general population, they have never previously been shown for a multinational population of hemodialysis patients.
“The ISN Fellowship prize was a great surprise and a very nice recognition,” said Dr. Calice-Silva. “My fellowship at RRI has been of great inspiration, allowing me to meet people from different fields and regions of the world who work together with one unique aim, to improve patient care and outcomes. It has been a period of personal and professional learning that certainly will enable me to provide even better care for my patients in the future.”
Dr. Calice-Silva, a nephrologist who practices in Brazil, joined RRI as a Research Fellow in June 2014. Nephrologists from approximately 30 countries have served as RRI fellows since the organization’s fellowship program was created in 1997.
“She’s doing outstanding work with us,” said Dr. Peter Kotanko, research director at RRI. “The award is really important. It is a great testament to how RRI interacts with academic institutions abroad. These kinds of collaborations with academic institutions give rise to such really great research, which is internationally recognized.”
Dr. Calice-Silva’s primary work at RRI involves analyzing congestive heart failure, arrhythmia and sudden cardiac death data from the international Monitoring Dialysis Outcomes (MONDO) data base, to identify predictors of death due to these conditions. Her work at RRI will continue through the end of April 2015.
About Renal Research Institute
The Renal Research Institute (RRI), a division of Fresenius Medical Care North America, conducts research in collaboration with our academic and teaching hospital partners in the US and abroad, aimed at improving the health outcomes and quality of life of patients with renal disease. RRI operates dialysis clinics in six states, primarily under the Avantus Renal Therapy brand. Patients treated at an Avantus Renal Therapy clinic benefit most directly and immediately from the latest insights gained at RRI into improving renal care. RRI puts its research findings and innovative technologies to work for our patients while setting a higher standard for quality of care.
About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier health care company focused on delivering the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, as well as the country’s largest practice of hospitalist and post-acute providers, FMCNA provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s only vertically integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. (www.fmcna.com)
Media Contact:
Fresenius Medical Care
Jon Stone, 781-699-9704 (o) / 781-392-4680 (cell)
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DaVita Clinical Research to Present Clinical Quality Results at the National ... - PR Newswire (press release)
DALLAS, March 25, 2015 /PRNewswire-USNewswire/ -- DaVita Clinical Research (DCR), a specialty contract research organization with services spanning the full spectrum of drug and device development and subsidiary of DaVita HealthCare Partners Inc., today announced that company representatives will present health-related quality posters at National Kidney Foundation's (NKF) 2015 Spring Clinical Meeting (SCM), which takes place March 25-29, 2015 in Dallas.
DaVita Kidney Care, the kidney care division of DaVita HealthCare Partners Inc., and DCR are committed to improving patient care and experience through real-world pilots that may enhance clinical outcomes.
The results shared by DaVita Kidney Care and DCR representatives at NKF SCM highlight innovative clinical quality programs focused on the following:
Improving the patient experience for individuals on dialysis
Decreasing hospitalizations, readmissions and other complications associated with missing dialysis treatment
Empowering patients to actively manage their kidney disease through education
NKF SCM is a platform for the nation's kidney care providers to learn about new developments related to all aspects of nephrology. Over the last several years, DCR has contributed to advancing the practice of nephrology by presenting numerous original research findings at the annual NKF SCM.
"Innovative clinical programs are critical to improving care for complex patient populations like those with kidney disease," said Steven Brunelli, M.D., vice president of health economics and outcomes research for DCR. "The work we present at NKF's Spring Clinical Meeting highlights the benefits of incorporating research methods into the design of pilot programs so that the effectiveness of such programs can be evaluated rigorously and contribute substantively to the practice of evidence based medicine."
Outcomes from the following DCR and DaVita Kidney Care clinical quality initiatives will be shared during the poster session on Thursday, March 26, from 6:00 to 7:30 p.m.:
Engaging patients in a social work-based program to help prevent missed dialysis treatments, decrease incidence of depression and increase overall quality of life through the poster "Symptom Targeted Intervention Decreased Missed Treatments In Hemodialysis Patients," presented by Shaun Boyd, LCSW, social worker for DaVita Kidney Care, poster 318
DCR seeks to advance the future of medicine, the practice of medicine and to innovate through personalized medicine. DCR and DaVita Kidney Care share a dedication to improving the health and quality of life for kidney care patients.
Through research and innovative clinical initiatives, DaVita Kidney Care has continuously improved clinical outcomes for patients each year since 2000. Recently, the company's dialysis centers were ranked in Centers for Medicare and Medicaid's (CMS) Five-Star Rating System, along with all other kidney care providers across the nation. It was reported that in the new rating system, DaVita Kidney Care centers account for 50 percent of the four- and five-star centers. Individuals can learn more at davita.com/five-star.
DaVita Clinical Research and DCR are trademarks or registered trademarks of DaVita Healthcare Partners Inc. All other trademarks are the property of their respective owners.
About DaVita HealthCare Partners DaVita HealthCare Partners Inc., a Fortune 500® company, is the parent company of DaVita Kidney Care and HealthCare Partners. DaVita Kidney Care is a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. As of Dec. 31, 2014, DaVita Kidney Care operated or provided administrative services at 2,179 outpatient dialysis centers located in the United States serving approximately 173,000 patients. The company also operated 91 outpatient dialysis centers located in 10 countries outside the United States. HealthCare Partners manages and operates medical groups and affiliated physician networks in Arizona, California, Nevada, New Mexico, and Florida in its pursuit to deliver excellent-quality health care in a dignified and compassionate manner. As of Dec. 31, 2014, HealthCare Partners provided integrated care management for approximately 837,000 patients. For more information, please visit DaVitaHealthCarePartners.com.
About DaVita Clinical Research DaVita Clinical Research(DCR), a wholly owned subsidiary of DaVita HealthCare Partners Inc., uses its extensive, applied database and real-world health care experience to assist pharmaceutical and medical device companies in the design, recruitment, and completion of clinical trials including retrospective and prospective pragmatic trials. DCR's scientific and clinical expertise spans the lifecycle of product development with more than 150 client companies. DCR's Biorepository, Early Clinical Researchunit (Phase I-IIa) and Late Phase Clinical Research (Phase IIb through post-marketing) network of physicians and investigative sites, data research, Health Economics & Outcomes Research, Central Laboratory, and Medical Communicationsare focused on providing world-class research in both complex/specialty populations and therapeutic areas, and especially in CKD and ESRD populations. To learn more about DCR, visit davitaclinicalresearch.com.
Contact Information Media:
Bianca Violante
Office: (303) 876-6614
Mobile: (443) 417-6044
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Kidney Stones Often Prompt Second ER Visit - Renal and Urology News
March 25, 2015
Nearly 1 in 3 of kidney stone patients required hospitalization or an urgent temporizing procedure at their second emergency visit.
(HealthDay News) -- The need for repeat high-acuity care affects 1 in 9 patients discharged from initial emergency department visits for kidney stones, according to a study published online in Academic Emergency Medicine.
Charles D. Scales Jr., M.D., from the Duke University School of Medicine in Durham, N.C., and colleagues analyzed data from all patients in California initially treated and released from emergency departments for kidney stones from February 2008 through November 2009. The authors sought to identify associations between patient-level characteristics, area health care resources, processes of care, and the risk of repeat emergency department visits.
The researchers found that among 128,564 patients discharged from emergency care, 11% had at least 1 additional emergency visit for treatment of their kidney stone, with nearly 1 in 3 of these patients requiring hospitalization or an urgent temporizing procedure at the second visit.
On multivariable analysis, the risk of an emergency revisit was associated with insurance status (e.g., Medicaid versus private insurance; odds ratio [OR], 1.52). Greater access to urologic care was associated with lower odds of an emergency revisit (highest versus lowest quartile OR, 0.88). Performance of a complete blood count was also associated with decreased odds of revisit (OR, 0.86).
"Efforts are indicated to identify preventable causes of emergency department revisits for kidney stone patients and design interventions to reduce the risk of high-cost, high-acuity, repeat care," the authors write.
Social Security helps people with kidney disease - Cheraw Chronicle
Every March, we pay special attention to the kidney, an organ vital to a healthy life. Social Security wants to help spread the word about the importance of kidney health and about what you should do if you think you or a loved one has a kidney-related disability.
Kidney disease prevents your kidneys from cleansing your blood to their full potential. Did you know that one out of three Americans is currently at high risk for developing kidney disease? According to the Centers for Disease Control and Prevention, 20 million Americans have chronic kidney disease, and most of them don’t even know it.
Ebie is a prime example. Ebie was an emergency room worker with an active life at work, home and in his community. He had no idea he’d developed a kidney condition until one day he felt ill while driving to work and had to call a coworker for help.
Our Faces and Facts of Disability website features Ebie’s story. He says people who receive Social Security disability benefits “can provide for themselves and have a high quality of life.” As Ebie explains, many people with kidney diseases can greatly increase their quality of life with Social Security benefits. You can learn more about Ebie’s story at www.socialsecurity.gov/disabilityfacts.
If a kidney disease such as end-stage renal disease (known as ESRD) requires chronic dialysis and prevents you from working, Social Security may be able to help you. If you’re undergoing dialysis, have had a kidney transplant, have persistent low creatinine clearance levels or have persistent high serum creatinine levels, you may qualify for disability and/or Medicare benefits.
You can find more information about eligibility based on kidney disease and the benefits available to you by reading our publications, “Disability Benefits” and “Medicare,” both available at www.socialsecurity.gov/pubs.
Listed as one of Social Security’s Compassionate Allowance conditions, kidney cancer is another condition that may qualify you for disability and Medicare benefits. The Compassionate Allowances program assists in cases where a person’s medical condition is so severe it obviously meets Social Security’s disability standards — allowing quick processing of the disability application and payment of benefits. You can find more information about Compassionate Allowances by visiting our website at www.socialsecurity.gov/compassionateallowances.
Drink plenty of water, go for checkups, and if you think you may have a kidney disease, take action right away! As Ebie says, “quality of life is everything.”
If you think you may be eligible for Social Security disability benefits based on a kidney disease, please don’t wait. Go to www.socialsecurity.gov/disabilityssi, where you can apply for benefits online.
Brenda Brown is a public affairs specialist for the Social Security Administration based in Fayetteville, North Carolina.