Another product of the Affordable Care Act, the Sunshine Law (also called Open Payments) begins implementation this year. The law requires manufacturers and group purchasing organizations publicly report certain transfers to or transactions with physicians. The goal is transparency and avoiding improper influence of physician’s prescribing practices. Physicians should make sure any information reported about them and their financial transactions with manufacturers is accurate. To do that, they will likely lean heavily on their practice administrator. This article will help you respond to the new Sunshine Law disclosures.
Sunshine Law basics
Here are the basics you need to know about the Sunshine Law and what it means for your practice:
What is being reported?
The new law requires manufacturers of drugs, devices, biologicals and medical supplies and certain group purchasing organizations annually report to CMS the following information:
- Manufacturers must report payments and transfers of value they make to physicians and their practices.
- Manufacturers must also report certain ownership or investment interests held by physicians or their family members.
- Certain group purchasing organizations (including those physically located or operating in the US) must report physician (or family member) ownership and transfers to physician owners.
Physicians addressed in this reporting include doctors of medicine and osteopathy, dentists and dental surgeons, podiatrists, optometrists and chiropractors.
The data reported for 2013 must include individual payments or transfers of $10 or more, or aggregate payments of $100 or more when multiple payments are made in the same year to a physician. Those numbers are adjusted according to the consumer price index so 2014 payments that must be reported are those $10.18 or over or aggregate payments over $101.75.
CMS then publishes the reported data on a public website so anyone can see what arrangements exist between manufacturers and GPOs and providers.
Why is this important to your practice?
You may have noticed that it’s the manufacturers and GPOs that have reporting obligations—not the physicians. So, many physician practices may think they don’t need to do worry about the Sunshine law because technically, they aren’t required to do anything. But ignoring the law is not a good idea. Your physicians and the practice should know what the public–and your patients and the government—will be told they received from manufacturers and GPOs.
Why? Well, as with any system, errors can occur. If the database inaccurately reports that your physicians or practice received payments or hold ownership or investment interests in an entity, you can get the report corrected (we’ll tell you how, below). Although there are legitimate reasons for these types of payments, the public perception may be that these payments create a bias when it comes to prescribing drugs and devices. So avoid any unnecessary issues with that perception by ensuring your physicians aren’t credited with receiving some benefit they didn’t really get. Even when the reporting is accurate, physicians should be aware of what is reported so they can respond to patient questions and explain the legitimate services related to that payment.
While you may think many patients have no idea about this law and may not take the time to look at the database, you could be wrong. Maryland health care attorney William T. Mathias, of Ober Kaler, notes that this transparency concept isn’t a completely new idea. Several years ago, medical device companies entered into settlement agreements with federal prosecutors obligating them to publicize all consulting arrangements they had with physicians. Mathias notes the media can review reports under such agreements or the Sunshine Law and call public attention to payments or arrangements.
He adds that physicians working part time for academic medical centers may be very concerned about what is reported. Such institutions often have detailed policies about accepting anything of value from the industry and these payments could violate their employment agreement, Mathias explains. So physicians listed as receiving payments or holding ownership or investment interests in industry could face some questions from any teaching facility with which they are involved.
Don’t forget too that the government will also have access to the database. There is no indication the OIG plans to use the Open Payments system to ferret out fraud and abuse but Mathias indicates it is “definitely a possibility.” Remember too, it’s not just payments but ownership and investment interests that will be publicly reported as well. The reporting could call certain arrangements into question with the government. Thus, physicians and their practices need to be checking to make sure accurate data is reported.
What your practice should do now before data is published
So, what should you do? As practice manager, you should emphasize the need to track all payments or transfers of value received by individual physicians in your group or by the practice generally. You also need to make sure you can compare your practice’s records with those reported to CMS by manufacturers and GPOs. Tell your physicians it’s important that the practice participate in CMS’s Open Payments system.
Mathias encourages all physicians to register in the Open Payments system so they get a notice when information is reported about them. Your physicians can do that on the CMS Open Payments website, which is listed in the resource section at the end of this article. The registration link wasn’t available yet at the time we went to press but CMS predicted it would be ready in January 2014. Registering ensures your physicians get a chance to review information reported and address and resolve with the manufacturers any inaccuracies before the information is made public. Each physician creates a user profile that they must update or confirm annually. Although manufacturers and GPOs have deadlines for registration, physicians can register any time. But there is a limited amount of time in which physicians can review reported information and request corrections. CMS cautions that registering after that window for reviewing and disputing manufacturer’s reported information means CMS can’t guarantee that corrections will be made before the data is made public. So if your practice’s physicians aren’t yet registered, make sure they register.
CMS also encourages physicians to “[k]eep records of all payments and other transfers of value received from applicable manufacturers or applicable GPOs.” Mathias agrees, suggesting practices “start having some type of digital records so you can protect your practice from false or inaccurate reports.” You want organized and accessible data about your interaction with manufacturers’ representatives and GPOs so you can quickly check the accuracy of reported information.
How to track benefits from industry reps
You can keep paper records of manufacturer representatives’ visits and the payments or transfers made. But electronic recordkeeping can simplify and speed the task, particularly for large group practices.
CMS has a free mobile app available to help physicians track transfers of value they receive from manufacturers. It is available at the Google Play™ app store or iOSApple™ app store. Search for “Open Payments” to find it. CMS indicates the app is password protected and allows the user to record and edit information about each payment or transfer received. A summary of the information recorded can be exported using email so physicians can all transfer data tracked on their mobile devices to a group practice computer for administration. A QR code helps with transfer of data to another user’s device, such as physician profiles, industry representative profiles and details regarding individual transactions. CMS cautions that the data is only stored on the local device (not on a CMS database) so CMS recommends users make frequent backups of the data recorded via their mobile app. One important reason to make frequent backups is that a security feature allows the user to try entering a password up to 10 times and if the correct password isn’t entered on the 11th try the information stored will be erased.
Another electronic tool that could be used to track this information is a web-based platform, RxVantage, which helps physician practices manage their relationship with industry representatives visiting their practice. Like the CMS mobile app, use of this platform is free for medical practices and there is a free version also for industry representatives. James A. Dwyer, Vice President of Sales at RxVantage explains that the platform facilitates scheduling by allowing practice managers to fill out profiles that specify the practice’s parameters for manufacturer representatives’ visits to the office. For example, the practice can list time slots during which they will accept visits from representatives, rules for frequency of visits, directions to the office, parking instructions, product sample requests and even dietary restrictions for cases in which food will be provided as part of the meeting, Dwyer explains. Industry representatives can also create profiles providing contact and other information and sign up for visits to the practice in the web platform, according to the parameters set by the practice.
A new feature of RxVantage helps practices track payments or transfers of value subject to reporting under the Sunshine Law. Using this feature, the cost of any meals, payments or other benefit provided to the practice physicians can be recorded. For meals during meetings, the system even allows the practice to record which physicians were in attendance. “It’s the same as a sign in sheet that representatives will have,” explains Dwyer. The practice can generate a report showing the amount a representative has spent at a particular office or by provider, adds Dwyer. It’s a “snapshot in time,” he says.
Dwyer suggests using RxVantage gives physicians and practices “peace of mind.” That’s because as Mathias noted, physicians have a small window of time to review and challenge inaccurate reports to the Open Payments database before they are made public. Having the data immediately available electronically allows physician practices to more efficiently check and refute reporting of transfers to its physicians. Dwyer indicates that RxVantage has plans to add a feature that will provide alerts “when a threshold is reached or almost reached.” For example, says Dwyer, it can send an alert that a particular physician has received $80 through attendance at meals with an industry representative.
Regardless of whether you use the CMS mobile app or the RxVantage resource be aware that it’s not just benefits received at representatives’ visits that you need to track. You also have to track any benefit received at any time from a manufacturer or GPO and any ownership or investment interest your physicians or their family members may have in a relevant manufacturer or GPO.
Editor’s Note: One manufacturer we found, Genentech, provides a tracking feature on its website that allows providers to see what the company has recorded as being received by providers from the company. Other manufacturers may have similar options. You should still keep your own records, however, to compare with the manufacturer’s data.
How to dispute data reported
Using your own data about transfers of value and ownership/investment interests held, you should check the accuracy of what manufacturers and GPOs have reported to CMS concerning your practice physicians. As we said above, after reports are made to CMS, there is a “review and resolution period” that begins at least 60 days before the data is publicly published. Once data is reported, physicians have 45 days to review the information and dispute any reports that are inaccurate. Physicians work with the manufacturer or GPO to resolve the dispute. If the dispute isn’t resolved in those 45 days, the data is publicly reported but noted as under dispute. After the 45-day period, physicians still have another 15 days to dispute data but any changes may not be shown in the publicly published data.
Editor’s Note: Some manufacturers may already publicly post this data on their own websites. Like the device companies Mathias mentions, some manufacturers may be required to publicly publish such information as a condition of settlement agreements or corporate integrity agreements with the government.
Click here for a complete list of resources to help you deal with the Sunshine Law as it relates to your medical practice.
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