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By James Swann
Aug. 5 - With the Sept. 30 deadline nearing for the public release of Sunshine Act information, providers and health-care attorneys are growing less confident of the accuracy of the data and the overall efficiency of the Open Payments program, industry stakeholders say.
Complaints with the physician review and dispute process were partially substantiated Aug. 3, when the Centers for Medicare & Medicaid Services temporarily took the system offline to look into a potential problem with physician payment data.
After a 12-day suspension, the CMS restored the Open Payments system on Aug. 15, allowing physicians to once again register to review and dispute payment data.
While the review and dispute period was originally supposed to end Aug. 27, the 12-day suspension led the CMS to extend the period until Sept. 8, according to a subscriber e-mail released Aug. 15.
The CMS e-mail said an investigation into a physician complaint "found that manufacturers and group purchasing organizations (GPOs) submitted intermingled data, such as the wrong state license number or national provider identifier (NPI), for physicians with the same last and first names."
Beyond the data accuracy problems illuminated by the temporary shutdown of the Open Payments systems, physicians have complained that the registration process is cumbersome and difficult.
For example, a spokeswoman for the American Medical Association told Bloomberg BNA Aug. 4 that physicians are having a hard time reviewing and disputing potentially inaccurate payment data about them that has been provided to the Centers for Medicare & Medicaid Services by pharmaceutical companies and group purchasing organizations (GPOs).
Physicians have a limited amount of time to dispute any inaccurate data before it's released to the public, and "we are hearing of a number of issues that physicians are experiencing with the cumbersome Open Payments registration process, which is just one part of the complicated three-phase process physicians must go through to review and dispute potentially inaccurate data," the AMA spokeswoman said.
"While government websites aren't known for being user friendly, the existing website to register, review and dispute is particularly challenging," the spokeswoman said.
Laura F. Laemmle-Weidenfeld, an attorney with Jones Day in Washington, told BNA Aug. 6 that the temporary suspension of Open Payments may have been due to a computer system glitch that "reportedly allows information about physicians with the same names in different states to be inaccurately combined."
Laemmle-Weidenfeld said that she expects the CMS will extend the Sept. 30 deadline "to allow more time to fix bugs, allow physicians to navigate what appears to be a complicated registration and review process, and determine whether any additional glitches are preventing the system and its databases from operating as intended."
"Fairly or not, these computer system challenges are reminding the public of the problems CMS faced when registration on the exchanges first went live and CMS was criticized for not working all the bugs out in advance," she said.
Due in part to concerns over the physician registration process, the AMA, along with over 110 state medical groups and industry associations, called on the CMS to delay the public release of Open Payments data from Sept. 30 to March 31, 2015, according to a letter released Aug. 5.
The six-month delay would "compensate for this year's six month delay in providing the opportunity for physicians to register, contrary to Agency communications throughout 2013 representing that physicians would be permitted to do so beginning January 1," the AMA letter said.
The letter also said "our organizations have serious concerns that Agency guidance gives manufacturers the power to unilaterally dismiss disputes that were initiated by physicians or teaching hospitals," and asked the CMS to issue guidance that manufacturers and GPOs can't unilaterally dismiss physician disputes.
The Open Payments program requires manufacturers of drugs, devices and other medical supplies and group purchasing organizations to report certain payments to physicians or teaching hospitals.
Payment data for the last five months of 2013 were due to the CMS June 30, and the data will be available to the public no later than Sept. 30.
Since July 1, physicians and teaching hospitals have been able to register for the CMS Open Payments system, which provides alerts when any data about them are submitted and allows them to review and dispute the data before they are publicly posted.
Physicians have reported several problems to the AMA regarding the review and dispute process, the spokeswoman said, including:
• a requirement to create a registration profile on the CMS Enterprise Portal before registering for the Open Payments program, which takes several steps and involves the submission of detailed personal information;
• no clear guidance on where to go to register in the Open Payments system;
• an Open Payments registration process that takes at least 30 minutes and has taken some physicians over two hours;
• a requirement that the Open Payments registration process be completed in one sitting, with no data saved if a physician comes back to the process later; and
• a requirement that registrations can only be done using the Internet Explorer browser.
Additionally, the AMA spokeswoman said that some physicians have completed their registrations, attempted to review their information and received error messages.
"This can be confusing as it means that you have been successful in registering, yet nothing has been reported by manufacturers," the spokeswoman said.
To help physicians review and dispute their payment data, the AMA has created guides for each step of the registration process, available on the AMA website.
In addition, the AMA has created a hashtag on Twitter, #SunshineTips, where physicians can share tips and best practices for registering with the Open Payments program and reviewing and disputing payment data, and maintains an online resource guide, the Physician Sunshine Act Tool Kit .
"We continue to be concerned about the short time frame of just 45 days to register, review and dispute reported data and want to remind all physicians about the importance and urgency of making sure their information is accurate before it is released by CMS," AMA President Robert M. Wah said in a July 31 statement.
Kirk Ogrosky, an attorney with Arnold & Porter LLP, Washington and former head of criminal enforcement for the Department of Justice, said problems with the Open Payments program may lead to a deadline extension.
"If sticking to the September 30, 2014, deadline means going live with a flawed system, CMS will continue to shake public confidence in their capability," Ogrosky told Bloomberg BNA Aug. 4.
Ogrosky said the Centers for Medicare & Medicaid Services may have to extend the deadline past September, and he said signs are pointing that the CMS will do this.
On July 3, for example, the CMS proposed amending the Open Payments regulations, "suggesting that CMS is experienced difficulties with interpretations and reporting," Ogrosky said.
Additionally, he said the CMS continued to release guidance, frequently asked questions and notifications after the payment data reporting was under way.
"I predict that some physicians will be confounded by reported values, and surprising physicians with calculation methodologies could cause serious relationship problems," Ogrosky said.
"Without physicians and manufacturers having the time to tackle data issues with patients, institutions and other interested parties, we may see yet another round of misleading reports," he said.
Kirk Nahra, an attorney with Wiley Rein, Washington, told Bloomberg BNA Aug. 4 that any large-scale data project, such as the Open Payments program, always comes with complexity and anticipated difficulties.
"HealthCare.Gov experience hopefully taught CMS some lessons, but we haven't seen anything yet that should give us a lot of confidence on how this activity will go," Nahra said. "I always tell my privacy and security clients that new projects like these regularly lead to security problems and other unexpected challenges almost as a matter of course."
While acknowledging glitches in the Open Payments program and even the potential need for a deadline extension, Danielle M. Sloane, an attorney with Bass, Berry & Sims PLC, Nashville, Tenn., told Bloomberg BNA Aug. 4 that the program has already helped reduce fraud in the health-care system.
"The Open Payments system has already had an impact in curbing potential abuses knowing that the information will become public and, of course, has had a financial impact on the medical device and pharmaceutical manufacturers who have had to implement infrastructure to track and gather the data that CMS has requested," Sloane said.
Sloane said it wouldn't be surprising if there was a delay in the public reporting of Open Payments information, as "it is a lot of data and a new system."
"To the extent that there are glitches that impact timing, the effect is simply a delay in the public learning of potential conflicts," she said, while a "more significant impact would be system glitches that impacted accuracy, which could impact the reputations of physicians, teaching hospitals and drug and device manufacturers."
Sloane said that while problems with the Open Payments program would be unfortunate, they wouldn't carry the same significance as the problems that affected the rollout of HealthCare.gov.
"It's gathering and reporting date, not giving people access to health care," she said.
"The data may eventually impact an individual's choice of physician and hospital, but it will not impact their costs of services or ability to obtain health-care services," Sloane said.
A delay of the September deadline might be a smart move for the CMS, Kathleen McDermott, an attorney with Morgan, Lewis & Bockius LLP, Washington, told Bloomberg BNA Aug. 5.
"It is certainly wise for CMS to consider delay rather than let a faulty system go live to the public, and to extend the time for physicians to check data," she said.
McDermott said it's understandable that new computer systems designed to collect large amounts of granular data "may have many bugs to work out and early use by physicians to view payment data for accuracy is not encouraging that the system is ready to go."
However, she said that the public and the physicians and institutions that are the focus of the reported data "all deserve a credible working system," and therefore the "CMS should take the time to get it right."
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The AMA letter to the CMS is at http://op.bna.com/hl.nsf/r?Open=jswn-9mpq6w .
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