Frequently Asked Questions About the Sunshine Act
What You Need to Know About the Sunshine Act
The Sunshine Act requires manufacturers of covered drugs, devices, biologicals and medical supplies operating in the United States to report to the Centers for Medicare & Medicaid Services (CMS) any payments or transfers of value they make to teaching hospitals or physicians in the USA.
When does data collection begin?
As of August 1, 2013, manufacturers are required to collect data on payments or transfers of value. Reports will be made annually and will be posted on a public website after September 30, 2014.
What kinds of payments are reported?
Manufacturers will report any payments or transfers of value exceeding $10. They will also be required to report transfers or payments of value arising from speaking or attending a non-accredited/non-certified CME, as well as any lodging, meals, speaker fees or travel funds the speaker physician receives. Educational materials given to a physician that are not meant to be of benefit to the patient or not used with the patient will also be reported, as well as meals at meetings where the physician is identifiable to the manufacturer. Finally, indirect transfers made to a third party when the manufacturer “requires, instructs or directs” the payment or transfer of value be provided to a physician.
When payments or transfers of value for research happen, the physician serving as the principal investigator gets reported, as well as the institution performing the research. Research payments will be displayed by CMS in a separate section of the Open Payments public website.
What should I do to prepare?
CMS is creating a portal as part of its Open Payments Program website, where covered recipients like physicians and teaching hospitals can register to see whether their name is included in a manufacturer’s submitted report. Being registered with the Open Payments portal allows physicians and teaching hospitals to receive timely notification on when they’ve been mentioned in a manufacturer’s report. It also provides a forum in which they can dispute the information included within the manufacturer’s report. Physicians can register with the Open Payments physician portal beginning in January 2014.
WHO Global Neurology Network for ICD-11 Diseases of the Nervous System Being Formed
The World Health Organization’s Department of Mental Health and Substance Abuse is forming a global network of primary care and neurology professionals to help inform the development of the classification of Diseases of the Nervous System in the next version of the International Classification of Diseases (ICD-11), currently planned for publication in 2015.
When you register for the new Global Neurology Network (GNN), you become a part of this international group of primary care or neurology professionals. You will be asked provide information and feedback to us based on your clinical expertise, experience, and knowledge as we develop the new classification of neurological disorders. This is of vital importance to ensuring that the new classification is clinically useful, easy to use and accurate.
If you choose to participate, you may be asked to review materials, offer feedback about ideas or concepts that we are developing, or participate in specific types of field studies. The information you provide will inform our decisions about the content and structure of the new classification system, as well as how that information will be presented to different users. The surveys that we send to you will be based on your own professional interests and areas of expertise.
Once registered in the GNN, you will receive survey requests no more than once a month, and each survey will take approximately 20-30 minutes to complete. Your participation will be completely voluntary, and your responses will be kept confidential, secure, and will not be released to anyone else. We will never ask you to provide information that could be used to identify any of your patients. Data are to be analyzed in aggregate form and used exclusively for the purpose of ICD revision. The first studies will begin during the coming months.
Huntington's Disease Global Clinical Trials Review, H2, 2013 Available for Purchase
Huntington's Disease Global Clinical Trials Review, H2, 2013 provides data on the Huntington's Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Huntington's Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Huntington's Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by our team of industry experts.
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-Pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations
- Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type
- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner
- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more
- Obtain discontinued trial listing for trials across the globe
- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
For more information please visit Huntington's Disease Global Clinical Trials Review.
- Clinical Trials by Region
- Clinical Trials by Country
- Top Five Countries Contributing to Clinical Trials in Asia-Pacific
- Top Five Countries Contributing to Clinical Trials in Europe
- Top Countries Contributing to Clinical Trials in North America
- Clinical Trials by BRIC Nations
- Clinical Trials by G7 Nations
- Clinical Trials in G7 Nations by Trial Status
- Clinical Trials by E7 Nations
- Clinical Trials in E7 Nations by Trial Status
- Top Companies Participating in Huntington's Disease Therapeutics Clinical Trials
- Five Key Clinical Profiles
For more information please visit Huntington's Disease Global Trials Clinical Review
Electronic (Single User): EUR 1908
Electronic (Site License): EUR 3817
Electronic (Enterprise-wide): EUR 5725
Ordering - Three easy ways to place your order:
1) Order online at Huntington's Disease Global Trials Clinical Review
2) Order by fax: Print an Order Form and fax to +353 1 4100 980
3) Order by mail: Print an Order Form and mail to Research and Markets, Guinness Center, Taylors Lane, Dublin 8 Ireland.
Ipsen's Commitment to Improving Patient Care Helps MDS Disseminate Knowledge About Movement Disorders
MDS has a long tradition of providing the highest quality evidence-based medical education. That tradition would not be possible without the help of the Society’s many supporters, including Ipsen Pharma SAS. As a partner dedicated to improving patient care through education and research, Ipsen has made a multi-year commitment to MDS educational programming. This ongoing relationship helps MDS plan several years into the future and reach new geographic areas.
- Ipsen's support at the Platinum Plus level helped make the 2011 MDS International Congress a great success with 3,750 attendees from 74 countries. Eighty-five percent of the 213 learning objectives in 71 courses or workshops in the Congress scientific program met the established threshold of effective learning.
- Ipsen helped support the MDS-European Section 2011 Summer School in Naples, where 86% of attendees rated their ability in the topics as excellent or above average after the activity, compared to an average of 37% before the activity.
- Ipsen helped support the Diagnosis and Treatment of Dystonia Syndromes course in Milan (September, 2011), where 56% of attendees rated their ability in the topics as excellent or above average after the activity, compared to an average of 10% before the activity.
- Ipsen helped support the Botulinum Toxins in Neurological Practice Workshop in Liverpool (October, 2011), where 43.2% of attendees rated their ability in the topics as excellent or above average after the activity, compared to an average of 18.5% before the activity.
In addition, Ipsen has made multiple future support commitments which will help MDS plan future educational activities.
How Well Is Your Doctor Caring for People with Parkinson's Disease?
New AAN Tool Helps Measure Care
St. Paul, Minn. -- The American Academy of Neurology has developed a new tool to help doctors gauge how well they are caring for people with Parkinson's disease. The new quality measures are published in the November 30, 2010, issue of Neurology, the medical journal of the American Academy of Neurology.
"Quality measures have been developed for conditions seen by primary care doctors for years, but not for many specialty care conditions such as brain disorders," said lead quality measures author Eric M. Cheng, MD, MS, with David Geffen School of Medicine at UCLA and a member of the American Academy of Neurology. "Measuring the quality of health care is a fundamental step toward improving health care, and many quality measurement efforts are under way. The American Academy of Neurology is taking a leading role in ensuring that the quality of care for people with neurologic disorders is included in these efforts."
The Academy measures for Parkinson's disease help doctors to determine how well they are caring for nonmotor symptoms of the disease such as depression, sleep and falls. "These symptoms can be overlooked but have a great impact on a person's quality of life," Cheng said. The measures also include assessing symptoms, treatment and counseling a person on preventable complications of the disease.
"Quality measures like these will be increasingly important for extending the best care possible to people with neurologic disorders like Parkinson's disease," said Cheng.
The AAN is working on developing similar measures in epilepsy, stroke, dementia, neuropathy, headache and multiple sclerosis.
It is estimated that about 1 million people in the United States have Parkinson's disease.
The American Academy of Neurology, an association of more than 22,500 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, stroke, migraine, multiple sclerosis, brain injury, Parkinson's disease and epilepsy. For more information about the American Academy of Neurology, visit www.aan.com.
PSG Mentoring Committee Announces Advisor Program For New Investigators
The Parkinson Study Group Mentoring Committee has developed an Advisor Program for new investigators who are initiating a research career or continuing an existing research area.
PSG has established a bank of advisors who are willing to help you find a local mentor in your area (both research and geographic) or help you find specific research funding sources (foundations, etc) for your research. The advisors would not be the mentors per se, but rather facilitate finding a mentor or help you begin a research career in a certain area.
If you would like to participate in this program, please complete the application form on the PSG website (www.parkinson-study-group.org) and you will receive a response within 7 business days.
Both the advisor and advisee will keep confidential any information received or obtained as a result of participating in the program that is identified as or would be reasonably expected to be confidential, unless they agree otherwise.
If you have any questions, please contact Roseanna Battista at email@example.com. We hope you take advantage of this program and we look forward to providing an enriching experience for you!
Joel Perlmutter, MD, Chair
Jon Stoessl, CM, MD, Co-chair
Cindy Comella, MD, Ad-Hoc member
Participants Sought for Neuroacanthocytosis and Deep Brain Stimulation (DBS) Project
The EC-funded (E-Rare JTC 2009) EMINA project (European Multidisciplinary Initiative on Neuroacanthocytosis) links a network of six partner organizations in Germany, Austria, the Netherlands, France and Turkey, in order to use their combined expertise to take a significant step forward in both basic research and applied clinical research into neuroacanthocytosis (NA) syndromes.
Within this project, led by Adrian Danek and Benedikt Bader, Munich, cases of NA (ChAc/chorea-acanthocytosis and McLeod Syndrome) who underwent DBS surgery to treat their movement disorder are collected. The aim of this EMINA sub-project is to propose recommendations for DBS surgery in NA based on a review of cases and on expert opinion.
If you are willing to participate in this case study by filling out a short retrospective data collection sheet and questionnaire, please contact Professor François Tison, MD, PhD at firstname.lastname@example.org.
MDS Accepting Applications for the Visiting Professor Program
The Movement Disorder Society (MDS) is currently accepting applications for countries interested in hosting a Visiting Professor in the MDS-sponsored Visiting Professor Program.
The MDS Visiting Professor Program provides educational opportunities in Movement Disorders to regions of the world that are under represented in MDS and do not have regular access to educational programs in Movement Disorders.
For more information or applications for this program, please click on the following link, http://www.movementdisorders.org/education/visitingprofessor.shtml or contact Kirk Terry, Director of Education, at +1 414-276-2145.