Article Date: 1/24/2009
On Thursday, two senators increased the pressure further by reintroducing legislation that would require device and drug makers to report all financial links with doctors on a federal Web site.
That bill is known as the Physician Payments Sunshine Act, and a parallel effort is in the House.
Link:http://www.corpwatch.org/article.php?id=15279 (Link will open in a new tab.)
Article Date: 1/22/2009
Since filing this report the Physician Payment Sunshine Act has been included in the final version of the Patient Protection and Affordable Care Act (PPACA). Press the following link to read a summary of the version the Physician Payment Sunshine Act that is now law.
Link:http://www.policymed.com/2009/01/physician-payment-sunshine-act-2009-introduced.html (Link will open in a new tab.)
Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website.
Link:http://www.cchrint.org/tag/physician-payment-sunshine-act/ (Link will open in a new tab.)
United States drug and medical device manufacturers are coming under new obligations to disclose billions of dollars in payments and gifts to physicians and researchers.
Whether it’s dinner for a doctor, a $2000-a-day moonlighting gig or a multimillion-dollar research arrangement, these payments are a prime marketing tool for industry and a lucrative source of extra income for physicians.
Legislators decided patients and the larger public have a right to know who is paying for what — and to whom.
Link:http://www.cmaj.ca/earlyreleases/19may10-new-us-law-applies-sunshine-to-physician-payments.dtl (Link will open in a new tab.)
Gifts between pharmaceutical and device manufacturers and prescribing physicians and hospitals have been the focus of regulatory scrutiny for some time now, and recently resulted in wholesale bans, coupled with payment reporting requirements, in both Vermont and Massachusetts. Under section 6002 of PPACA, the reporting requirements of the Massachusetts and Vermont laws have become nationally applicable (along with some new requirements). In fact, the new “Physician Payment Sunshine” provisions significantly expand on the Massachusetts and Vermont laws in at least one important way.
Link:http://www.lexology.com/library/detail.aspx?g=bbac8fc4-39f6-4931-ab58-de0b9d1bc8b3 (Link will open in a new tab.)
Article Date: 4/26/2010
Doctors who accept speaking fees, five-star meals and other compensation from pharmaceutical or medical device companies will soon see their names – and the value of the gifts they accept – revealed on the Web, under a new federal law that follows several states in drawing attention to such financial benefits.
The experience of one of those states – Vermont – suggests that highlighting the medical industry's largesse may curb the payments.
Link:http://www.kaiserhealthnews.org/Stories/2010/April/26/physician-payment-disclosures.aspx (Link will open in a new tab.)
Although some companies find the logistical pain subsiding under the Sunshine Act, operational challenges loom. Companies that have already begun publishing physician payments will have to alter some of their disclosures to provide more transparency. This increased transparency may drive some KOLs away from working with the industry.
Companies that have not begun to publicly disclose physician payments have a lot of catching up to do. The good news for these companies is that drug makers will not need to report any transfers of value until January 1, 2012, so there is time to outline plans.
Link:http://pr-usa.net/index.php?option=com_content&task=view&id=390312&Itemid=32 (Link will open in a new tab.)
Starting in 2013, the Physician Payments Sunshine Act (PPSA), which was part of the health care reform bill, will require that every industry payment to physicians over $10 be reported in a publicly available database. Many if not most of the NIH grantees who also have financial ties to industry are MDs and will wind up in that database.
Link:http://www.gooznews.com/node/3355 (Link will open in a new tab.)
Article Date: 5/19/2010
Section 6002 of the Health Care Reform Act sets forth the applicable reporting requirements, penalties and exclusions thereto. Notably, this provision of the Health Care Reform Act was based on the Physician Payment Sunshine Act, a bill originally introduced in 2007 by Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) and re-introduced in 2009 in an attempt to promote transparency regarding conflicts of interest issues that may occur when physicians receive payments or other benefits from drug and medical device manufacturers.
Link:http://www.mondaq.com/unitedstates/article.asp?articleid=100250 (Link will open in a new tab.)
Article Date: 9/26/2008
A Lilly spokesman said the company hoped others would follow its lead, a wish voiced by some independent experts.
"This is a good step, and one that should be emulated by other companies, even in the absence of legislation requiring it," Dr. Paul S. Appelbaum, a professor of psychiatry, medicine and law at Columbia University and the New York State Psychiatric Institute, said in an e-mail message.
Dr. Appelbaum said the simplest way to achieve comprehensive disclosure was for the industry itself to maintain public records. "Any physician who believes that disclosure is likely to be embarrassing," he said, "should not be accepting the money in the first place."
Link:http://www.natap.org/2008/newsUpdates/092608_02.htm (Link will open in a new tab.)
Article Date: 9/26/2008
In letters to Senate Special Committee on Aging Chairman Herb Kohl (D-WI) and Senate Finance Committee Ranking Member Charles Grassley (R-IA), Johnson & Johnson today announced its support for the Physician Payments Sunshine Act of 2009 (S. 301). The company also committed to begin voluntarily disclosing payments made to physicians by its U.S. pharmaceutical, medical device and diagnostics companies.
“We are in favor of greater transparency regarding the relationships between healthcare companies and physicians,” said Johnson & Johnson chairman and CEO William C. Weldon. “We continue to believe such transparency is in the best interest of patients, payers, other stakeholders in healthcare and the industry itself.”
Link:http://www.jnj.com/connect/news/all/20090507_130000 (Link will open in a new tab.)
Article Date: 1/22/2009
“Shedding light on industry payments to physicians would be good for the system,” Grassley said. “Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors’ advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine.”
Kohl said, “Since we first introduced the bill, there has been a groundswell of support from every corner. Patients want to know that they can fully trust the relationship they have with their doctor. I am confident this legislation will pass during the 111th Congress.”
Link:http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=18901 (Link will open in a new tab.)
“I am pleased to inform Senator Kohl and Senator Grassley that PhRMA believes the transparency provisions in the new revised bill are acceptable,” PhRMA President & CEO Billy Tauzin said today.
PhRMA commends efforts by Senators Kohl and Grassley to improve transparency while preserving the critical interactions with health care providers that help in developing new medicines and enhancing patient care.”
Link:http://www.phrma.org/news_room/press_releases/phrma_statement_on_the_senate_sunshine_act (Link will open in a new tab.)
Article Date: 2/8/2013
SUMMARY: This final rule will require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals ("covered recipients"). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public website.
These regulations are effective on 60 days after the date of publication in the Federal Register.
Compliance date: Applicable manufacturers and applicable group purchasing organizations must begin to collect the required data on August 1, 2013 and report the data to CMS by March 31, 2014.
Note to all users, we are accommodating the latest specifications to the law within the software so you will be compliant.
Link:https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-02572.pdf (Link will open in a new tab.)
Kaiser Permanente’s Robert Pearl is misleading the general public into thinking that a physician who partakes in a medical-education event at which a modest meal is provided is on the medical-device- or pharmaceutical-industry dole (“Medical Conflicts of Interest Are Dangerous,” op-ed, April 24).
Link:http://stream.wsj.com/story/latest-headlines/SS-2-63399/SS-2-222672/ (Link will open in a new tab.)
Article Date: 4/24/2013
As part of the Patient Protection and Affordable Care Act, more commonly known as Obamacare, Congress also passed the Physician Payment Sunshine Act (the "Sunshine Act") in an attempt to provide the public with a way to learn about the financial relationships that exist between physicians and teaching hospitals on the one hand and medical device and drug manufacturers on the other.1 The Sunshine Act requires applicable manufacturers to provide annual reports to the Centers for Medicare and Medicaid Services ("CMS") detailing all payments and transfers of value of $10 or more that the manufacturers made to physicians and teaching hospitals in the preceding calendar year.2 CMS will maintain these reports in a publicly-available online database.3 Congress and CMS (the agency charged with implementing the Sunshine Act) believe that these reports will allow patients to easily investigate the extent to which their doctors or hospitals accept payments or other transfers of value from drug and medical device manufacturers and will ultimately reduce healthcare costs by discouraging inappropriate financial relationships.
Link:http://www.mondaq.com/unitedstates/x/235540/Contract+Law/The+Physician+Payment+Sunshine+Act+A+Dawning+Of+New+Reporting+Requirements+For+Drug+And+Medical+Device+Manufacturers (Link will open in a new tab.)
The federal Center for Medicare & Medicaid Services recently announced final regulations for the Physician Payment Sunshine Act, which requires pharmaceutical and medical-device companies to disclose payments they make to doctors, hospitals and other health-care providers. This information will be publicly available starting in 2014.
Link:http://online.wsj.com/article/SB10001424127887324485004578426591868602604.html (Link will open in a new tab.)
Article Date: 4/16/2013
The long-awaited final regulations for the Physician Payments Sunshine Act (“Sunshine Act” or “Act”) were finally released on February 1, 2013. I previously discussed the Sunshine Act (seeHere Comes the Sun, Are you Prepared?,10/18/2012), but with the final rule now implemented, providers should take a second look at it and reconsider its implications.
Link:http://www.natlawreview.com/article/final-rule-physician-payments-sunshine-act-recently-released (Link will open in a new tab.)
As a feature of the Affordable Care Act (ACA), the Centers for Medicare & Medicaid Services (CMS) announced the final rendition of the Physician Payments Sunshine Act on Feb. 1. This portion of the ACA establishes a legal mandate and mechanism for physicians, group purchasing organizations and teaching hospitals to be reported when an economic benefit—$10 or greater—is provided from applicable manufacturers of pharmaceuticals, biologics and medical devices. These transactions will be collected beginning Aug. 1, 2013 and will be posted on a CMS public website beginning Sept. 30, 2014.
Link:http://www.generalsurgerynews.com/ViewArticle.aspx?d=Editorial%2BPage&d_id=66&i=April+2013&i_id=943&a_id=22856 (Link will open in a new tab.)
Article Date: 8/22/2013
U.S. doctors are bracing for increased public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law.
Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul.
Link:http://finance.yahoo.com/news/doctors-face-scrutiny-over-gifts-235700816.html (Link will open in a new tab.)
Article Date: 7/1/2013
Could the public reporting of these financial relationships invite enhanced scrutiny from state or federal investigators, lawmakers, and even private citizens? How might the public reports be used to combat fraud and abuse in government health care programs?
This article explores some of these issues and addresses how this new nationwide reporting system might impact enforcement of state and federal fraud and abuse laws.
Link:http://about.bloomberglaw.com/practitioner-contributions/physician-payment-sunshine-act-how-hot-could-it-get-in-the-sun/ (Link will open in a new tab.)
Article Date: 10/15/2013
The first two-plus months of tracking payments under the Physician Payment Sunshine Act are now in the rearview mirror. Though novel questions continue to arise (albeit with less frequency), CMS has attempted to keep up, offering additional FAQs. Several of the more recent FAQs are of particular interest to medical device manufacturers.
Link:http://www.lexology.com/library/detail.aspx?g=93f7fd1f-7274-4de3-bc8d-3ee0cccbc854 (Link will open in a new tab.)
Article Date: 10/21/2013
"I read a fascinating editorial in the New Yorker's Financial Page over the weekend that had me wondering if, instead of driving down the costs of healthcare by making financial transactions between physicians and pharmaceutical companies public, the section of the Affordable Care Act could in fact end up making those payments larger."
Link:http://meetingsnet.com/blog/transparency-sunshine-act-and-unintended-consequences (Link will open in a new tab.)
Article Date: 10/7/2013
“Do physicians know what the full implications are for them and their profession?” And the answer seems to be, some do, some don’t, and some are worried about it but many are not.40% of physicians currently accept food and travel from industry; 37% accept consulting and speaking fees; and 17% accept research grants. Overall, 74% of respondents allow for sales rep detailing.
22% say they “fully understand” the Sunshine Act; 7% have “no understanding” and the remainder fall between “minimal” and “some” understanding.
79% are aware that payments for sponsored research and consulting with industry are reportable to CMS; lesser percentages are aware of the details such as meals or third-party transfers. 74% are aware that these data will be made publicly available.
On the Big Question—“Do you feel your patients will lose trust in you if you have a relationship with industry?”—28% said “yes;” 43% said “no;” 16% said “don’t know;” and, somewhat puckishly, 3% said “don’t care.”
Link:http://pharmaceuticalcommerce.com/index.php?pg=latest_news&articleid=26992&keyword=PDMA-sunshine%20act-agg%20spend-QPharma-Shaw (Link will open in a new tab.)
Article Date: 2/27/2012
Supporters of the Physician Payments Sunshine Act failed to take into account how expensive "sunshine" would be. Requiring drug and medical device manufacturers to publicly report virtually every payment they make to physicians, physician groups and teaching hospitals will end up costing far more than the $224 million estimated for just the first year of compliance. The biggest cost will be the valuable, socially useful physician-industry collaborations that simply won't occur.
Link:http://usatoday30.usatoday.com/news/opinion/story/2012-02-27/Physician-Payments-Sunshine-Act/53276506/1 (Link will open in a new tab.)
Article Date: 5/30/2013
Information will be posted on a public website that will identify physicians who have received payments or hold ownership. Data collection begins in August 2013, with public reporting starting in 2014, under the National Physician Payment Transparency Program (NPPTP) of the Centers for Medicare and Medicaid Services (CMS).
Interest in public disclosure was stimulated by the extent of financial relationships between physicians and industry.
Link:http://www.nejm.org/doi/full/10.1056/NEJMp1303523 (Link will open in a new tab.)
Article Date: 7/30/2013
As the sole physician organization whose reach and depth extends across the nation, the American Medical Association (AMA) has been actively informing physicians about the Physician Payment Sunshine Act (Sunshine Act), which will require industry to report on their interactions with physicians beginning on Thursday, August 1. As required by law, these interactions will be published by the Centers for Medicare and Medicaid Services (CMS) starting in September 2014.
Link:http://www.ama-assn.org/ama/pub/news/news/2013/2013-07-30-sunshine-act-reporting-this-week.page (Link will open in a new tab.)
Article Date: 3/20/2013
But will the Sunshine provisions actually bring about such transparency? Will the compilation and release of data regarding payments to physicians and teaching hospitals actually clear the haze and give the public meaningful insight into the relationship between physicians on the one hand, and the device and pharmaceutical industries on the other? Or, at the other end of the spectrum, will the statute and accompanying regulations instead cast undue suspicion on relationships that are sometimes ambiguous, often symbiotic, and, in the case of medical research and study, actually beneficial to the public at large?
Link:http://www.forbes.com/sites/insider/2013/03/20/propublicas-dollars-for-docs-will-the-physician-payments-sunshine-provisions-clear-the-haze/ (Link will open in a new tab.)
Article Date: 6/13/2013
The hope behind the Sunshine Act is that public disclosure of payments will deter physicians from accepting payments from industry and create a culture of transparency in which the public can evaluate payment information and potential bias. The research community is certainly eager to access and analyze the payment data, but will patients seek out this information and use this site?
Link:http://healthaffairs.org/blog/2012/06/13/putting-the-patient-at-the-center-of-the-physician-payment-sunshine-act/ (Link will open in a new tab.)
Article Date: 12/21/2011
While there are currently a few states that already require such reporting in one form or another, and while some companies already post such information on their website as result of Corporate Integrity Agreements or other settlements with the federal government, the Sunshine Act will apply to all pharmaceutical and medical device companies, including companies that do not yet market products, whose products are or will be reimbursed under a federal healthcare program.
Link:http://www.metrocorpcounsel.com/articles/17100/physician-payment-sunshine-act-requirements-and-unresolved-questions (Link will open in a new tab.)
Article Date: 9/16/2013
Veteran LeClairRyan healthcare attorney offers a primer on Obamacare transparency rules, in Q&A article published by peer-reviewed AAFP journal.
Family physicians should act now to reduce the risk of being unfairly tarnished by misleading or inaccurate payment disclosures made via Obamacare’s so-called “Sunshine Act” provisions, cautions LeClairRyan attorney Patrick J. Hurd in the latest issue of Family Practice Management, a peer-reviewed journal published by the American Academy of Family Physicians.
Link:http://www.newsday.com/business/family-physicians-should-be-vigilant-about-sunshine-act-related-disclosures-hurd-says-1.6080178 (Link will open in a new tab.)
Article Date: 4/1/2013
By Paul Thacker
“Is this what you want to tell your investors?” I asked. “You want to tell them that you're shoveling so much money out the door to doctors that you can't even account for all of it?”
With enough pressure, industry eventually lined up behind the bill. But it took time—time and an enormous amount of pressure brought to bear by investigators working for Senator Charles Grassley. Was all this stress ever really needed?
Link:http://www.mmm-online.com/as-i-see-it-the-sunshine-act/article/285614/ (Link will open in a new tab.)
Article Date: 8/5/2011
Following lobbying by US MR association CASRO, the District of Columbia’s Board of Pharmacy has agreed to revise its regulations, which previously demanded the disclosure of payments made to physicians in exchange for participating in market research.
Link:http://www.mrweb.com/drno/news14047.htm (Link will open in a new tab.)
Article Date: 1/25/2012
In an article in Sunday's Wall Street Journal called "Who Paid for your Doctor's Bagel," Thomas P. Stossel, M.D. vehemently takes issue with the Physician Payments Sunshine Act, which requires that pharmaceutical companies that make drugs purchased by government programs publicly disclose any payments or perks they give to physicians with a value above $10.
Link:http://www.huffingtonpost.com/marilyn-wedge-phd/sunshine-act_b_1224731.html (Link will open in a new tab.)
Article Date: 5/7/2012
CMS has announced that the agency will not require companies to collect transparency data before January 1, 2013. The new timeline is a delay from the original Physician Payments Sunshine Act, which required HHS to come up with final reporting procedures by October 1, 2011. Instead, draft regulations were released in December of 2011; during the following 60-day comment period, CMS was bombarded with more than 300 comments from stakeholders.
Link:http://capsules.kaiserhealthnews.org/index.php/2012/05/aint-no-sunshine-yet-for-docs/ (Link will open in a new tab.)
Article Date: 10/28/2013
Medical sales professionals are just one example of a segment of the industry that will be impacted by the ACA, also known as Obamacare. A recent MedReps.com survey found that these professionals report high levels of career satisfaction (along with high earnings), but the unknown impact of the ACA is causing feelings of uncertainty and stress.
Link:http://medcitynews.com/2013/10/whats-effect-obamacare-medical-sales-reps (Link will open in a new tab.)
Article Date: 10/29/2013
As such, CMS recently adjusted the reporting threshold based on the consumer price index. For the 2014 reporting period (January 1 – December 31), applicable manufacturers are not required to report transfers of anything valued at less than $10.18, unless the aggregate amount transferred to, requested by, or designated on behalf of a covered recipient exceeds $101.75 in the calendar year.
Link:http://www.lexology.com/library/detail.aspx?g=4573ecb8-adf4-4406-8e96-22eb3dfd7373 (Link will open in a new tab.)
Article Date: 11/4/2013
Cloud computing involves the delivery of computing as a service rather than a product. In a cloud computing solution, shared resources, software, and information are provided much like a utility, over a network to computers and other devices. Cloud computing has been embraced by the medical industry, and is used as a vital technology in electronic medical record systems and telemedicine solutions, among other products.
Link:http://www.mondaq.com/unitedstates/x/271700/IT+internet/Cybersecurity+FDA+Risks+for+Medical+Devices (Link will open in a new tab.)
Article Date: 11/7/2013
In response to stakeholder requests, on November 19, from 1:00 p.m. to 3:00 p.m. EST, CMS will present the first two sessions in a series of technology-focused webinars designed to introduce features of the Open Payments system currently in development.
These webinars will focus on two major Open Payments components:
1. Registration, and
2. Data submission.
Go here to register for the November 19 Open Payments system webinar.
Who should attend these webinars:
• Webinar 1 (1:00 p.m. – 2:00 p.m.): Open Payments Registration
This first hour is targeted to individuals who represent manufacturers of drugs, devices, biologicals, or medical supplies, plus distributors, group purchasing organizations (GPOs), or other entities required to submit data under Open Payments. Other interested participants are welcome to attend.
• Webinar 2 (2:00 p.m. – 3:00 p.m.): Data Submission
This second hour is targeted to individuals responsible for creating data submission files for manufacturers of drugs, devices, biologicals, or medical supplies, plus distributors, GPOs, or other entities submitting data under Open Payments. Other interested participants are welcome to attend.
On December 3, 2013, CMS will host a follow-up Q&A session after participants have had the opportunity to fully review the data submission resources. More information on that webinar will be available following the November 19 webinars.
Details on the other upcoming sessions in the technology webinar series, as well as links to recordings of these sessions, will be available soon on the Open Payments Events page.
Link:https://event.webcasts.com/starthere.jsp?ei=1025494 (Link will open in a new tab.)
Article Date: 10/22/2013
The main contractor behind the problem-plagued Healthcare.gov website was hired this summer to create a new federal website listing payments from pharmaceutical and medical device makers to physicians.
CGI Federal was tapped in July to build the software platform for what the government has called its Open Payments website. The site, like Healthcare.gov, was created as part of the 2010 Affordable Care Act.
Link:http://cornstein.tumblr.com/post/64796980161/healthcare-gov-contractor-also-hired-for-drug-company (Link will open in a new tab.)
Article Date: 11/8/2013
Position Description: The Call Center Manager is responsible for supervising the day to day operations of an inbound/outbound call center, utilizing tools and processes in place to ensure ensure all client requirements are met. Requirements include meeting or exceeding the service level agreements in place, ensuring all call scripting is current and all team members are using the current standards, monitoring and maintenance of the telephony systems, and reporting on all required outcomes.
Link:http://www.simplyhired.com/job-id/ea472olf54/open-payments-jobs/ (Link will open in a new tab.)
Article Date: 11/27/2013
Scrutiny of physician relationships with industry has culminated in passage of the US Physician Payments Sunshine Act (part of the Affordable Care Act), intended to bring greater transparency to such relationships. However, according to authors in this week's PLOS Medicine, interactions with industry of non-physician clinicians--Registered Nurses, advanced practice nurses with prescriptive authority, physicians' assistants, pharmacists, dieticians, and physical or occupational therapists—have not undergone the same scrutiny, although they may be involved in the same types of decision making as physicians.
Link:http://www.sciencecodex.com/interaction_of_nurses_pharmacists_and_other_nonphysician_clinicians_within_pharmaceutical_industry_is_common-123812 (Link will open in a new tab.)
Article Date: 12/6/2013
Nearly two dozen members of Congress signaled solidarity with 41 medical boards and 33 physician associations in opposing the inclusion of textbooks and reprints in Sunshine Act reporting. The 23 House members—seven of whom are physicians—sent a letter to CMS to voice disagreement with an HHS decision to include textbooks and journals as “transfers of value” reportable under the Physician Payment Sunshine Act.
Link:http://www.mmm-online.com/house-members-oppose-cms-stance-on-reprints/article/324548/ (Link will open in a new tab.)
Article Date: 12/12/2013
Is a physician working in a postgraduate fellowship at an academic institution a “resident” or an independently practicing physician?
That’s a question the AMA’s Board of Trustees will take up at the request of the AMA House of Delegates.
Link:http://psychnews.psychiatryonline.org/newsarticle.aspx?articleid=1790283 (Link will open in a new tab.)
Article Date: 12/18/2013
GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual sales targets. In addition, GSK will extend its long-standing prohibition on providing direct financial support to health care professionals attending conferences in the United States to other countries
Link:http://www.natlawreview.com/article/glaxosmithkline-announces-further-limits-payments-to-physicians-and-sales-compensati (Link will open in a new tab.)
Article Date: 12/16/2013
The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest.
Link:http://www.nytimes.com/2013/12/17/business/glaxo-says-it-will-stop-paying-doctors-to-promote-drugs.html (Link will open in a new tab.)
Article Date: 12/16/2013
Open Payments will rely on IT to drive transparency; here is what CIOs and other healthcare IT leaders need to know
While much attention has been focused on the policy aspects of the new Open Payments (Physician Payments Sunshine Act) transparency program, there is a technical engine behind the policy which will make or break this initiative. When it comes to the success of the program and the process by which organizations will implement and comply with it, the role of information technology will prove pivotal.
Link:http://www.healthcare-informatics.com/article/guest-blog-it-supporting-business-open-payments (Link will open in a new tab.)
Article Date: 12/19/2013
As Oct. 1 rolled around and Americans began the process of enrolling in a health-care plan under Obamacare, amidst the chaos people around the country weren’t sure exactly how this law would affect them. Between changing health-care costs, enrollments from state to state not functioning correctly and the federal government shutdown, regular Americans simply wanted to know how this all would impact their daily lives. Lost in all this confusion is a portion of the law called Open Payments, a provision that will have real negative impacts on medical innovation and the vitality of American clinical research.
Link:http://about.bloomberglaw.com/practitioner-contributions/impact-of-the-sunshine-law-open-payment-provision-on-clinical-research/ (Link will open in a new tab.)
Article Date: 1/3/2014
WASHINGTON -- The coming year will usher in some monumental changes in the world of healthcare, and we have the dates to prove it.
Whether they are dealing with ICD-10, further rollout of the Affordable Care Act (ACA), or the "meaningful use" program for electronic health records, clinicians should note these key dates in 2014. Pay especially close attention to late March and early October.
Link:http://www.medpagetoday.com/PracticeManagement/PracticeManagement/43642 (Link will open in a new tab.)
Article Date: 1/13/2014
The Obama administration has tapped the world's largest consulting firm to take over its beleaguered Obamacare website.
Accenture, a consulting and technology services company with 281,000 employees and $28.6 billion in revenue, won the one-year contract to continue fixing HealthCare.gov, the online health insurance marketplace set up by the Affordable Care Act. The Centers for Medicaid and Medicare Services made the announcement Saturday.
Link:http://politicalticker.blogs.cnn.com/2014/01/11/white-house-awards-accenture-healthcare-gov-contract/comment-page-5/ (Link will open in a new tab.)
Article Date: 1/17/2014
Soon a public website mandated by the Affordable Care Act and supported by the Centers for Medicare and Medicaid Services will report all but trivial payments to the nation's physicians from pharmaceutical and medical device companies. The companies will be required to report honoraria, travel expenses, grants and even meals. The sunshine in the Physician Payments Sunshine Act is the light that shines by disclosure of these industry ties, and then it will be time for the public to interpret the findings.
Link:http://www.sfgate.com/opinion/article/Sunshine-law-may-keep-doctors-from-taking-5153519.php (Link will open in a new tab.)
Article Date: 1/23/2014
The Centers for Medicare and Medicaid Services (CMS) recently denied a request from a bipartisan group of 23 members of congress to exempt the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirements under the Physician Payment Sunshine Act (Sunshine Act). The regulatory preamble in the CMS final rule provides that educational materials (including medical textbooks) furnished to physicians for their own education, but that do not directly benefit patients, are subject to reporting under the Sunshine Act. 42 C.F.R. § 403.904(i)(4)...
Link:http://www.lexology.com/library/detail.aspx?g=80624082-e19b-43af-b21e-ae441164b9dd (Link will open in a new tab.)
Article Date: 2/10/2014
Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the Physician Payments Sunshine Act (the “Act”). The final rule implementing the Act (“Final Rule”) set a March 31, 2014 deadline for all data (covering August 2013 through December 2013) to be submitted to CMS through its Open Payments Program. In addition, CMS guidance provided in a previous webinar had indicated that manufacturers and GPOs covered by the Act would be able to register in “early 2014” and that registration would remain open for 90 days. The guidance, however, provided through an email announcement and on the Open Payments website, announced a delayed start of registration and explained that registration and reporting will now take place in two phases (for the first Sunshine Act reporting period only).
Link:http://www.healthlawpolicymatters.com/2014/02/10/more-open-questions-about-open-payments/?utm_source=Mintz+Levin+-+Health+Law+%26+Policy+Matters&utm_campaign=81734fba37-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_85e0fa7ce4-81734fba37-70357017 (Link will open in a new tab.)
Article Date: 2/10/2014
Last Friday, CMS issued a notice announcing the opening of registration for electronic Open Payments reporting under the physician payment sunshine provisions of the Affordable Care Act. (A previous post on the sunshine provisions and our memo summarizing CMS’s final implementing rule can be found here.) According to the final rule, issued almost one year ago, applicable manufacturers and GPOs must complete their reports by March 31, 2014 for payments and transfers of value made during the August 31-December 31, 2013 timeframe. However, in today’s notice, CMS indicates that the sunshine reporting will occur in two phases, the second of which will not be completed until June or later.
Link:http://medcitynews.com/2014/02/sunshine-reporting-registration-open-feb-18/ (Link will open in a new tab.)
Article Date: 2/7/2014
At CMS, we are committed to transparency. Thanks to the Affordable Care Act, we have powerful new tools to advance transparency in healthcare and provide consumers with information to help them make informed healthcare choices. The Open Payments program creates greater public transparency about the financial transactions among doctors, teaching hospitals, drug and device manufacturers, and other healthcare businesses. We’re pleased to share today the latest steps we are taking to bring accountability to healthcare as a result of Open Payments.
Link:http://content.govdelivery.com/accounts/USCMS/bulletins/a3f695 (Link will open in a new tab.)
Article Date: 2/11/2014
Partners for Healthy Dialogues partner Christopher White (general counsel, AdvaMed) recently sat down with Diane Biagianti, vice president, chief responsibility officer, Edwards Lifesciences, to talk about the importance of collaboration between physicians and medical technology companies, and implementing the Physician Payments Sunshine Act.
Link:http://medcitynews.com/2014/02/q-collaboration-physicians-medical-technology-companies-crucial/ (Link will open in a new tab.)
Article Date: 2/27/2014
For decades, it’s been no secret that some physicians have financial relationships with health care manufacturing companies. For example, a pharmaceutical firm might fund a cardiologist at an academic medical center to research an experimental medication for lowering cholesterol. Or, an orthopedic surgeon might receive a consulting fee from a medical device manufacturer for counsel about an artificial hip.
Link:http://healthaffairs.org/blog/2014/02/27/open-payments-a-matter-of-maintaining-trust/ (Link will open in a new tab.)
Article Date: 2/25/2014
The Centers for Medicare and Medicaid Services (CMS) has been busy this month. All in preparation for the first set of disclosure reports as required by the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.” In an effort to get our readers caught up on the Sunshine Act reporting frenzy, we have prepared the following timeline of recent events:
Link:http://www.lexology.com/library/detail.aspx?g=22d0f190-62e0-4736-94d6-832e48d4995b (Link will open in a new tab.)
Article Date: 2/24/2014
In compliance with the Physician Payments Sunshine Act, drug and device manufacturers started last week to report their payments to physicians. Letter to the editor:
The editorial "Is your doctor on a drugmaker's payroll?" tells an incomplete story that misleads the public and discourages collaborations that improve patient care and medicines.
Link:http://www.usatoday.com/story/opinion/2014/02/24/doctors-drugs-prescriptions-fees-your-say/5794543/ (Link will open in a new tab.)
Article Date: 3/8/2014
WASHINGTON – Mark DuVal’s law firm has been busy teaching medical device and drug makers how to obey the Physician Payments Sunshine Act.
It is no easy task, says DuVal, a Minneapolis attorney who used to work for Medtronic Inc. and 3M Co.
Link:http://www.startribune.com/business/249048431.html (Link will open in a new tab.)
Article Date: 3/6/2014
With the Open Payments System rollout, came the phased approach for data submission, requiring aggregate data in Phase 1 and detailed data reporting in Phase 2.
The Centers for Medicare and Medicaid Services (CMS) recently announced that its Open Payments System is now open for registration and data submission. The system was created to receive data submissions from Applicable Manufacturers and Applicable Group Purchasing Organizations (GPOs) as required under Section 6002 of the Patient Protection and Affordable Care Act (popularly known as the U.S. Sunshine Act). With this announcement came the new concept of a two-phased approach.
Link:http://www.mondaq.com/unitedstates/x/296376/Healthcare/Final+ACA+Shared+Responsibility+Regulations+Released&email_access=on (Link will open in a new tab.)
Article Date: 4/3/2014
Healthcare professionals (HCPs) working in the UK received a total of £38.5m from pharma companies, according to figures published by the country's trade body.
The Association of the British Pharmaceutical Industry (ABPI) calculated the aggregate figure based on data from 34 of the top 40 pharma companies for UK sales and said it had published the result as part of a greater commitment towards industry transparency.
Link:http://www.pmlive.com/pharma_news/pharma_paid_38.5m_to_uk_healthcare_professionals_in_2013_557827 (Link will open in a new tab.)
Article Date: 4/1/2014
RESEARCH TRIANGLE PARK, N.C. — Drug companies of all sizes have implemented compensation limits — or spending caps — to ensure they remain compliant with new Sunshine Act guidelines regulating payments to physicians. The average annual spending limit, according to Cutting Edge Information, is $58,000.
Read more here: http://www.heraldonline.com/2014/04/01/5826541/ensure-sunshine-act-compliance.html?sp=/100/773/385/#storylink=cpy
Link:http://www.heraldonline.com/2014/04/01/5826541/ensure-sunshine-act-compliance.html?sp=/100/773/385/ (Link will open in a new tab.)
Article Date: 4/7/2014
Ever since The Centers for Medicare & Medicaid Services, or CMS, issued its final guidelines in February 2013 for how life sciences companies need to comply with the U.S. Sunshine Act provision of the Patient Protection and Affordable Care Act governing payments and transfers of value to healthcare providers and healthcare organizations, drug and medical device manufacturers have had all hands on deck to ensure they collect the pertinent data in order to meet the first aggregate spend reporting deadline.
Link:http://meetingsnet.com/pharmadevice-regs/pharma-planning-meets-compliance (Link will open in a new tab.)
Article Date: 4/12/2014
While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies – with potential FCA implications.
Last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act.1 In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data.
Link:http://www.mondaq.com/unitedstates/x/306464/Healthcare/Will+Physician+Payment+Sunshine+Act+Data+Usher+In+A+New+Era+Of+False+Claims+Act+Litigation (Link will open in a new tab.)
Article Date: 4/10/2014
Doctors haven't disengaged from drug companies in the months since the tracking of financial relationships between them started, several pharmaceutical executives here said.
The Physician Payments Sunshine Act required drug companies to track gifts and other payments to physicians starting August 1, making them public later this year -- leading to fears that public shame or misunderstanding might come of doctors' relationship to pharma.
Link:http://www.medpagetoday.com/Washington-Watch/Washington-Watch/45207 (Link will open in a new tab.)