The first wave of US HCP payment data was released on 30th September 2014 under CMS' Open Payments System (widely known as Sunshine Act). The objective was to help consumers understand the financial relationships between the healthcare industry, doctors and teaching hospitals. The data lists consulting fees, research grants, travel reimbursements, and other gifts provided by industry to healthcare professionals (HCPs) and healthcare organisations (HCOs).
Text Simon Dufaur Global Director - Healthcare & Life Sciences, Regional Sales Director, Europe, MCI Brussels
Covering just the first five months of 2013, the numbers are huge: the Open Payments system contains 4.45 million payments valued at nearly $3.7bn to 546,000 physicians and nearly 1,360 teaching hospitals. The second year of data submissions is currently underway with publishing of 2014 data (plus any applicable updates to the 2013 data) slated for June 2015.
What must be reported under the Sunshine Act
• The name and address of the HCP
• The amount and date of the payment (if more than $10)
• The form of such payment (e.g. cash, stock)
• The nature of the payment (e.g. entertainment, gifts, consulting fees)
Relations between industry and clinicians are critical for improving patient care and clinical outcomes. It is commonplace in the industry to gather key opinion leaders to help industry understand the market and their business. Historically, these relationships between industry and physicians have been widespread. A 2007 study, published in the New England Journal of Medicine (NJEM)i revealed that 94% of US doctors surveyed had a relationship with industry; of those, 60% were involved in medical education and 40% in creating clinical practice guidelines.
Numerous studies have shown that payments are persuasive, no matter their size or form. For some watchdogs, the fact that there is a relationship is the determining factor and not the size of the transfer of value. However it was the ethical nature of these relationships that has been questioned, with a glut of news stories reporting on the trend to offer overtly lavish trips for doctors in the hope that this would increase prescription rates. Whilst those numbers published in NJEM above are now estimated to have dropped, the reputational legacy lives on. A recent article in the Times of India ran an article recently commenting on plans to ban industry from “doling out freebies, cruise tickets, paid vacations and sponsorships to educational conferences and seminars”ii. The US Open Payments system and the European EFPIA Disclosure Code have been created as a direct response to concerns that financial ties may unduly influence medical practice and research.
Inaccurate and incomplete?
The Open Payments data has already come under criticism as some medical societies claim the data to be inaccurate and incomplete. This follows some significant technical issues in the Open Payments database during the data upload and review phase. As such, many HCPs believe there was an inadequate opportunity to review their individual data, with many medical associations questioning the accuracy of the published information. The New York Times,iii reported on numerous problems in obtaining accurate tallies of all payments associated with each drug and device, with widespread misspelling in the submitted data, particularly over drug names, detracting from the usefulness of the published data.
Featuring around 2.6 million lines of identifiable general payments (of which, more than 1.7 million "transfers of value" were for less than $20), the Open Payments system has been criticised for making proper analysis difficult and not delivering the transparency it was intended to do. The time and resources required to filter through the data volume and complexity means that it is unlikely that the general public will get a true sense of the payments. Instead, it is seemingly far more probable that the public will rely on press articles for insights.
It has been interesting to see the range of media coverage that has surrounded the data release. Early press articles focused on the delays and technical challenges behind the roll-out of the Open Payments system. Media coverage since then has been surprisingly light with the majority of articles covering the issue from one of three standpoints:
• The potential thawing of collaboration between doctors and industry
• An objective analysis of the data
• A highlight of the biggest recipient doctors and hospitals
What about Europe?
Whereas the Open Payments system is an integral part of the US Affordable Care Act, most of the 34 countries in Europe affected by the EFPIA Disclosure Code are using persuasion, rather than legislation, to encourage disclosure. In fact, this will not be the first time that payments have been made public in Europe. A considerable amount of data is already in the public domain at the national level and several countries, including the Netherlands and France, already require public reporting of financial relationships. Experience from the Netherlands (where there is an annual cumulative threshold of €500 and no requirement to report individual transactions) has shown that the public are not interested in the amounts but if there is a relationship or not.
There is an inherent tension in Europe between transparency and privacy, with data and personal privacy becoming a key concern. With the exception of those few European countries where there is formal legislation requiring disclosure, the HCP has the right give or withhold consent over publication. Consent typically follows an explanation of the information to be disclosed and who will see it, and may be revocable at any time.
Non-disclosure is a major risk to the credibility of the industry. Most European associations wish to be seen to be welcoming the transparency initiative. Though, as MCI’s 2014 thought leadership paper highlightediv, the various stakeholders still need to learn to collaborate over promoting the benefits to patients and less over the intricacies of disclosure. Medical associations, industry and regulators across Europe, therefore, need to develop the right communications and information that will convince the concerned parties. HCPs should be convinced to participate and not to opt-out through non-disclosure, whilst the media should be convinced to consider the data carefully before passing judgment about physicians' and teaching hospitals' relationships with industry.
Transparency has become a very important professional value over the past 15 years, mirroring a progressive societal shift to greater transparency. There is a diminishing group of doctors, who are used to not disclosing anything; that said, one has to accept that not every doctor will accept it. Medical associations should focus on the significant majority who do and advise their members to prepare for inquiries from the media, colleagues and patients in advance of the EFPIA data release.
For industry, their credibility will be upheld through their interpreting the rules correctly and not skirting around them. After all, the skill in healthcare compliance is navigating the grey zone. It is unclear yet whether EFPIA will, like CMS, have audit authority over the submitted data but elect to not use it. The key test for EFPIA will be to get the same level of data consistency and to convey that transparency should not be viewed as a comment about the issue of the past but rather as paving the way for the next generation. The very publication of EFPIA disclosure data will inevitably draw more attention to the relationship between HCPs and industry. Compensation of doctors is normal and reasonable as long as the relation is fit for purpose and the amount is correct for the work done. The expectation is that transparent business relationships, free from corruption and unethical ties, will ensure that treatment and prescribing decisions are made in the best interest of the patient.
It is easy to get caught up in the technicalities and evolution of transparency codes, and one can easily lose sight of the patient. Just remember that even though it's being declared online, patients don't feel directly any better!
A seasoned healthcare executive, Simon directs MCI’s healthcare team in assisting medical associations and pharmaceutical companies manage increasingly complex regulatory changes and build high-level stakeholder alliances through strategic consulting and service development.
iii The New York Times, 22 Jan 2015, “Data on payments from drugmakers to doctors is marred by error”, Charles Ornstein, Ryann Grochowski Jones and Mike Tigas
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