This article is more than 5 years old. Information may no longer be current.
Open Payments program cycles into next round of reporting
Click Here to Manage Email Alerts
Lessons learned since the launch of the National Physician Payment Transparency Program are the impetus for government, industry and physician collaboration to improve the reporting system going forward.
Disclosure data from 2013 were posted on a federal government website in September 2014, and the deadline for companies to report 2014 data is fast approaching: March 30.
The Open Payments program, mandated by the Physician Payment Sunshine Act, requires industry to report payments made to physicians. Manufacturers of drugs, devices, biologics and medical supplies reimbursed by Medicare, Medicaid or the Children’s Health Insurance Program are required to disclose to CMS payments made to physicians and teaching hospitals, with a few exceptions. Manufacturers and group purchasing organizations are required to report physician ownership and investment arrangements.
Physicians and teaching hospitals may review and dispute reports each year. Before the first round of reporting was published, physicians and teaching hospitals disputed about 9,000 records submitted by manufacturers. As a result, industry advocates are working with CMS to improve the reporting process, according to John Murphy, JD, assistant general counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA).
“The initial implementation was rocky, but we learned a lot from the experience,” Murphy said. “There were a lot of updates that CMS had to release and a lot of growing pains, but none of it was insurmountable. At the end of the day, everybody was able to mostly get out the expected work products that I think Congress had envisioned.”
Problems encountered during the launch of the Open Payments website led CMS to change data matching protocols, according to Christopher L. White, JD, AdvaMed general counsel.
Image: AdvaMed
Christopher L. White, JD, general counsel of the Advanced Medical Technology Association (AdvaMed), discussed the herculean task of fine-tuning and improving the reporting system.
Problems encountered during the launch of the Open Payments website led CMS to change data matching protocols, according to Christopher L. White, JD, AdvaMed general counsel.Image: AdvaMed
“It was a less than Olympian launch, for certain,” White said. “I think the agency had a lot of technical challenges to overcome, but we’ve continued to work with the agency on a proactive basis to improve the overall presentation of data to better reflect the nature of these relationships.”
In December 2014, CMS added about 68,000 records of payments and transfers valued at more than $200 million to the Open Payments dataset. The records had been disputed or mistakenly excluded from publication, according to a CMS press release.
With the new data, reported payments and transfers to nearly 546,000 individual physicians and 1,360 teaching hospitals totaled $3.7 billion, according to the release. CMS had de-identified some lines of data due to matching issues in the database and is now working with companies to reconcile the data, according to Murphy.
“We don’t expect that that’s the sort of thing that will continue now that we’ve all learned from the process,” he said.
The next round of reporting will present challenges, but stakeholders will continue to refine the reporting system, Murphy said.
“This next round, which will start in March for the 2015 reporting year, will be another test for both CMS and the industry because it’s going to be a whole lot more data than in the first round,” he said. “I think this will be the year we really learn where all the additional bugs are. We have had a relatively open-door policy with CMS, and CMS has been very good about seeking feedback from industry on how to refine and resolve some of the issues that have arisen. So, I think this will be another learning year, but I think it will be much better than last year.”
Problems encountered during the launch of the Open Payments website led CMS to change data matching protocols, White said.
“[We were] disappointed with the data integrity issues that precluded a full disclosure immediately upon launch. There were various categories of data issues,” he said. “But those issues have been addressed and we’ve moved beyond that, and we’re pleased that for future years CMS has provided clarity into its data-matching algorithm and methodology. They are developing a validated physician profile that should be very helpful in the future.”
Early response to disclosures
According to two experts, early reactions to disclosures ran the gamut from a lack of interest to the use of data to allege improper industry-physician relationships.
Abraham Gitterman
Abraham Gitterman, JD, of the Washington, D.C., law firm Arnold & Porter, said that media outlets and government agencies may use data from the Open Payments website to support allegations of improper activity. But raw data alone cannot be used to readily identify malfeasance, Gitterman said.
Abraham Gitterman
“[You] can’t rely on public information as your sole source of authority,” he said. “[You] couldn’t necessarily just point to information that’s publicly available and say, ‘I have firsthand knowledge of this company engaging in unlawful conduct.’”
Michael X. Repka, MD, medical director for governmental affairs, American Academy of Ophthalmology, noted that interest in the Sunshine Act’s implementation among physicians was “amazingly underwhelming.”
“I don’t think we have a concept of how many of our [AAO] members accessed the data to validate or verify it during the verification period, but I understand that nationally the percentage was quite low. I saw that about 5% of doctors looked at it. My own institution urged people to do it, but I suspect a lot of people did not because they thought it was fairly time-consuming to get logged in,” he said.
The Sunshine Act may have a long-term negative impact on collaboration between industry and physicians, Repka said.
“Relations with industry are vital to advancing medical care,” he said. “If you don’t work with the people who are involved in developing technology, pharmaceuticals and devices, I think that has got to slow down development. The interchange between clinical and research is invaluable.”
Layers of disclosure
Open Payments reporting is just one layer of disclosure. The other layers are state sunshine laws and corporate integrity agreements. Some states have disclosure laws that differ from the Sunshine Act.
“Some of those states have a gift ban law. Sunshine does not impose an absolute ban on any payments. But if you pay a physician in certain states, such as Massachusetts, Minnesota or Vermont, that payment must be allowable under state law. So, that’s one of those challenges that keep going on,” Gitterman said.
The reporting requirements may change somewhat if a bipartisan bill introduced in Congress in January becomes law. The Protect Continuing Physician Education and Patient Care Act, H.R. 293, would exempt companies from reporting textbooks and other educational materials given to physicians, according to a summary of the bill.
Dispute resolution
White said that the dispute resolution process needs improvement.
“Medical device companies want to resolve disputes where they exist as efficiently and expeditiously as possible,” White said. “Of course, we hope there would be no disputes because the companies are taking their obligations very seriously, but where those disputes or misunderstandings exist, medical device companies want to work in good faith with teaching hospitals and physicians to resolve them.”
One drawback to efficient dispute resolution is that there is no mechanism for companies to contact physicians directly.
“If a physician or teaching hospital files a dispute, the company has notice of a dispute and can re-examine the data and work in good faith to address it,” White said. “But, ultimately, a dialogue would be most helpful. Unless the physician or teaching hospital includes a contact name and number in their dispute, there’s no way for that to occur. That’s an area we think could use some improvement as we look ahead.”
Michael X. Repka
AAO member physicians should take an active role in resolving disputes and making a case for physician-industry collaboration, according to Repka.
“The manufacturers had a huge job to do to get their systems in place, and there can be mistakes that are reported,” he said. “We can at least clear those up. That’s what our members can do. Then, they have to be prepared to explain the value of physician-industry cooperation and how they think it would improve innovation and make it more timely.”
According to White, the Sunshine Act adequately defines the context of proper industry-physician relationships, but that information is not readily accessible on the Open Payments website.
“We were pleased that there is some context that describes these relationships, so it’s not simply a compilation of names and dollar figures and one- or two-word labels associated with those payments,” White said. “However, it’s a couple clicks away from the data, and we worry that the valuable context that was so important to our support of this legislation at the outset is obscured or not easily accessible. That continues to be a concern, and we’ve offered some potential solutions to the agency.”
Specific contextual issues such as fair market value for payments may become an issue for government, whistleblowers, industry and physicians themselves, Gitterman said. For example, a physician may receive $500 for consulting from one company and $10,000 for consulting from another company, but the Sunshine Act database does not distinguish what the consulting was for. Without knowing fair market value of the service, one would have difficulty inferring any wrongdoing, according to Gitterman.
“That’s going to be important, the fair market value,” Gitterman said.
Interpretation of data
In May 2014, CMS proposed to share physician payment data with other federal agencies such as the Department of Justice. The proposal is intended to help government agencies investigate possible incidences of fraud and other improprieties.
However, proving allegations of fraud is almost impossible using only raw data from the Open Payments website. Simply basing an evaluation on the frequency and number of interactions between a company and physician cannot attain the level of detail needed to establish evidence of impropriety, according to Gitterman.
“You would really need documented evidence to show that, No. 1, these payments were for the purpose of a fraud, that they were intended to induce this physician to use that manufacturer’s products in an otherwise improper or unnecessary way. That’s a high level of burden for someone to prove. You cannot simply do that by just pointing to a database,” Gitterman said.
Murphy cited confusion among the public and media over the nature of industry-physician relationships.
“[There] still seems to be a fair amount of confusion among the larger general public as to what’s really represented in the database,” Murphy said. “I think there’s still a misaligned notion among several in the consumer space that say, ‘Well, these are just the payments to doctors for prescribing drugs,’ when, in fact, that couldn’t be further from the truth.”
Murphy said that industry and CMS have been trying to clarify the nature of proper relationships.
“I understand that [people] don’t necessarily understand how research and development are conducted in the pharmaceutical industry or how physicians go about learning about new technologies and new products. So, we’re working very hard and in partnership with CMS to continue to drive that dialogue out there,” he said.
Self-regulation
All PhRMA member companies are committed to participating in Open Payments, Murphy said.
“[From our companies’ perspective], we were relatively supportive of the passage of this law as far back as before the ACA, when this was being bantered around as a standalone bill, because transparency is something that the industry has supported. I think we’ve made a pretty profound commitment to that,” he said.
The PhRMA Code on Interactions with Healthcare Professionals, a set of voluntary guidelines, has been in place for several years, Murphy said.
“That continues to be a guiding principle that our members verified their compliance to on a yearly basis,” Murphy said. “But the Sunshine Act is obviously slightly different in that the PhRMA Code sets forth a list of guidelines on how to establish a compliance program. The Sunshine Act is really the opposite of that. It doesn’t prohibit or prescribe anything; it simply requires reporting. So, the two work in tandem, from our industry’s perspective, by setting forth some best practices on compliance with the PhRMA Code and then allowing for transparency on the back end with the Sunshine Act.”
AdvaMed’s Code of Ethics conforms to the Sunshine Act, Anti-Kickback Statute and other laws, White said.
“You can see that the definition in the Sunshine Act and the exceptions largely align in turn with the AdvaMed Code of Ethics. For example, the Sunshine Act requires reporting of certain consulting payments. Our Code of Ethics addresses consulting payments squarely and sets out a series of guidances on how those arrangements ought to be structured,” he said. “In our work with the agency, we were also optimistic that the context that would be provided would refer specifically to our Code of Ethics. It does not, but it provides examples that are consistent with our Code of Ethics.” – by Matt Hasson
References:
CMS updates Open Payments data. CMS website. www.cms.gov/OpenPayments/Explore-the-Data/CMS-Updates-Open-Payments-Data.html.Code of ethics. AdvaMed website. advamed.org/issues/1/code-of-ethics.
Code on interactions with healthcare professionals. PhRMA website. www.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf.
Financial transparency: Open Payments overview. AAO website. www.aao.org/advocacy/reimbursement/open_payments/index.cfm.
Open Payments. CMS website. www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html.
Physician Payments Sunshine Law. AdvaMed website. advamed.org/issues.detail/16.
Protect Continuing Physician Education and Patient Care Act (H.R. 293). Library of Congress website. www.congress.gov/bill/114th-congress/house-bill/293?q=%7B%22search%22%3A%5B%22H.R.+293%22%5D%7D.
Rudolf P, et al. CMS proposes to share physician payment Sunshine Act data with federal agencies. Healio.com. www.healio.com/cardiology/practice-management/news/online/%7B536261a3-c85b-478c-803a-580ea28618d2%7D/cms-proposes-to-share-physician-payment-sunshine-act-data-with-federal-agencies.
For more information:
Abraham Gitterman, JD, can be reached at Arnold & Porter LLP, 555 Twelfth Street, NW, Washington, D.C. 20004-1206; email: abraham.gitterman@aporter.com.John Murphy, JD, can be reached at PhRMA, 950 F St. NW, Washington, D.C. 20004; email: newsroom@phrma.org.
Michael X. Repka, MD, can be reached at American Academy of Ophthalmology, 20 F St. NW, Suite 400, Washington, D.C. 20001; email: mrepka@jhmi.edu.
Christopher L. White, JD, can be reached at Adva-Med, 701 Pennsylvania Ave. NW, Suite 800, Washington, D.C. 20004; email: amcmaster@advamed.org.
Disclosures: Gitterman, Murphy and Repka report they have no relevant financial disclosures. White reports he is general counsel of AdvaMed.
Have you visited the CMS Open Payments website to verify that your payment information was reported correctly, and if you did, what were your impressions?
Physicians should check profiles to ensure accuracy
John A. Hovanesian
Every physician should check his or her own profile to ensure accuracy. You will find, as I did, that most of the entries recorded there are very small items. If a company representative buys you a $2 cup of coffee, they have to report it on the site. Clearly, the drug and device industry is spending a lot more money doing mandatory tracking of these transactions than the transactions themselves amount to.
In general, I favor transparency of relationships between physicians and industry. Most of us have nothing to hide, and there are standards of ethics in our interaction that we have followed since long before governmental reporting was mandated. Physicians can learn a great deal from our industry counterparts about how better to care for patients using products that are now approved. Through consulting and advisory boards, we can give back guidance for future life-improving products that one day will be.
John A. Hovanesian, MD, FACS, is OSN Cataract Surgery Section Editor. Disclosure: Hovanesian reports no relevant financial disclosures.
Website is an accurate accounting
Uday Devgan
The CMS Open Payments website is an accurate accounting of physician payments received from medical industry programs, research, consulting and other relationships. Even before the launch of this website, I had in place a policy of giving patients a list of ophthalmic companies with which I have worked, in the interest of full disclosure.
Physicians take an oath to do what is in the best interests of their patients, applying what I call the golden rule of medicine in which doctors aim to give the same high level of care that they would want for themselves or their own family. In that light, I always choose the pharmaceutical and medical device products that I feel are best suited for the patient, regardless of any consulting or research work that I have performed.
Having this website is a good move for industry, physicians and patients. With everything out in the open, there is transparency of the financial relationships that exist between physicians and industry. It is these consulting and research relationships that are crucial for the development of the next generation of pharmaceutical and medical device products that will ultimately benefit patients.
Uday Devgan, MD, is OSN Healio.com/Ophthalmology Section Editor. Disclosure: Devgan reports he is a paid consultant to multiple ophthalmic companies.