Protect the privacy of your patients and the reputation of your facility.
Training that’s smarter, more effective, and cost efficient.
Automate the COI disclosure and management process.
As we wait to learn about the future of the Affordable Care Act (“Obamacare”), what’s not known at this time is the potential impact of proposed changes on the continued operation of the CMS “Open Payments” database.
Many individuals personally involved in the healthcare industry are familiar with the “Open Payments” database published each year by the Center for Medicare and Medicaid Services (CMS). This database, sometimes referred to as the Physician “Sunshine” database was created as a part of the Affordable Care Act in 2010 and requires that pharmaceutical companies and medical device manufacturers report payments made to physicians and teaching hospitals for services such as promotional talks, consulting, research, and royalty agreements.
With the publication in 2014 of the CMS “Open Payments” database, which makes all payments to physicians from Pharmaceutical and Medical Device companies available in a searchable database, conflicts of interest has become a hot-button issue in healthcare.
One of the challenges that governmental and institutional authorities face in evaluating the efficacy and cost effectiveness of therapeutics is determining who to rely on for technical and scientific support. On one hand, who better to explain the relative advantages of a new product than the inventor of a device, or the researcher who has overseen the development of a new and promising drug? On the other hand, who could be more invested in a favorable determination on safety and effectiveness?
Demonstrated Competency is a learning feature that provides significant benefits for learners and learning administrators. What is the biggest complaint from learners? “Training takes too much time!”
Over the last few months, the country was gripped by the story of a measles outbreak that started at Disneyland and spread to cities around the country. This outbreak was part of an upward trend. The CDC reported more than 600 cases of measles in 2014, and as of the end of February, 170 cases had been reported in just the first two months of 2015. Before 2014, the number of measles cases had exceeded 200 in only one year since 2001. Many in the medical community have pointed to the increase in the number of unvaccinated children as the main reason for this sudden increase in cases.
Now questions are being raised turning these concerns about conflicts of interest on their head. Some physicians are asking if incentive programs designed to improve quality and cost effectiveness, by promising increased revenue through “gainsharing” to physicians for attaining specific results, are creating conflicts of their own.
The data included remuneration and other exchanges of value from August to December, 2013 from pharmaceutical and medical device companies to physicians, medical schools and other providers. Those with the wherewithal to download and analyze the 150+ megabytes of data posted in seven distinct database files began to provide some analysis within a few days.
The Physician Payment Sunshine Act requires that all manufacturers of drugs, devices, and biological and medical supplies covered by federal health care programs report all financial relationships with physicians and teaching hospitals to the Centers for Medicare and Medicaid Services (CMS). The goal of the law is to enhance patient safety by increasing the transparency of financial relationships between health care providers and pharmaceutical manufacturers. CMS will then report the information publicly on a website scheduled to be launched on September 30, 2014.
As a healthcare administrator your responsibility is to "do the right thing" and to ensure that your staff acts with integrity at all times. Often, doing the right thing can be difficult and unpopular and you might feel as if you are swimming against the current. This list of famous quotations may help for those times when you need some extra motivation to do the right thing or to remember why it's critically important to maintain integrity! I hope you'll refer to this often.
As public access to this “Physician Payment Sunshine” database gets closer, many hospitals and physicians have started to seriously consider the impact of this data on public perceptions and institutional reputations. There is little doubt that local media outlets will be all over this data when it becomes available in September, looking for payments to physicians that they can portray as excessive and scandalous.
The companies represented at the conference used their Communication Department to publically promote the ethical values of their organization. These organizations want the world to know that they follow a code of ethics. This includes a willingness to publically communicate failures in meeting the ethical and compliance standards they set for themselves and how they dealt with those failures.
As a psychiatrist, Dr. Pies delves more deeply than some into matters of the mind. He quotes ethicist James DuBois as saying: “…an induced COI is said to exist when a researcher knowingly creates situations of financial or other types of dependency that may compromise judgment,” but then points out that “…physicians and other researchers are not always aware of their own COIs, and are truly surprised when an outside observer points it out to them; thus, not all COI is conscious or ‘knowing.’”
In hospitals and academic medical centers, much of the focus on COI is on disclosure and reporting requirements related to the federal government, particularly for reporting to the NIH (for research) and to the IRS (for the form 990). There is, however, another important area where, (to quote Arthur Miller) “attention must be paid!” That is in procurement. Executives and compliance officers have a responsibility to assure that the resources of their institutions are protected, by guarding against conflicts of interest in the procurement process.
On August 1st, Pharmaceutical and Medical Device manufacturers will be required to begin collecting data on payments to physicians and other providers under the “Physician Payment Sunshine” provisions of the Affordable Care Act. Physicians are being urged, by professional societies, the American Hospital Association, the AMA and others to educate themselves on the “Sunshine” provisions so that they can accurately track and, if necessary, correct the payment information that will be reported in public databases in September 2014.
In July, 2008, The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association and lobbying group for the pharmaceutical industry, updated their Code of Interactions with Healthcare Professionals. This was followed in July, 2009 by an update to the AdvaMed Code, which provides the same function for the Medical Device industry. In both of these documents, the industry went further than ever before in recommending limits on the marketing efforts of their members.
The “Sunshine” provisions were designed to increase transparency in industry’s formal and informal relationships with medical providers. Ever since astute observers noticed that physicians could be influenced by financial considerations (the Stark anti-kickback laws date to the 1980’s) there has been concern that industry largesse could unduly influence research results, prescribing patterns, continuing medical education, and even practice patterns. The thinking is, to paraphrase Justice Brandeis, “Sunshine is the best disinfectant”.
A pair of researchers in the Cal psychology department staged an experiment. They began by grabbing students, as lab rats. Then they broke the students into teams, segregated by sex. Three men, or three women, per team. Then they put these teams of three into a room, and arbitrarily assigned one of the three to act as leader. Then they gave them some complicated moral problem to solve: say what should be done about academic cheating, or how to regulate drinking on campus.
Most involved parties agree that Conflicts of Interest – both financial and non-financial – carry the risk of adversely influencing medical treatment and research decisions. For this reason steps have been taken by public and private entities alike to require the identification and management of such conflicts.
Much attention has been paid to the new NIH disclosure rules, which went into effect on August 24th. The rules require that institutions obtain disclosure of “Significant Financial Interests” from all those conducting or in a position to influence research, and have a process in place to identify and disclose what they determine to be “Financial Conflicts of Interest”. Much of the discussion about the rules has centered on how conflicts of interest might impact the design, conduct or presentation of funded research.