In response to the need for more information as discussed in the previous article, the following is a comprehensive overview of the information most relevant to physicians regarding Open Payments, including a one-page Quick Facts sheet for future reference.
The Centers for Medicare and Medicaid (CMS) stated intent of Open Payments is to provide “a national resource for beneficiaries, consumers, and providers to know more about the relationships among physicians, teaching hospitals, and industry.” Open Payments requires applicable manufacturers and group purchasing organizations (GPOs), known as “Reporting Entities,” to report to CMS any payments or other transfers of value they make to physicians and teaching hospitals. Manufacturers and GPOs must also report certain ownership or investment interests held by physicians or their immediate family members. That data will be collected, aggregated, and published annually by CMS on a public website.
According to CMS, bona fide physician employees of applicable manufacturers are excluded from Open Payments, as are medical residents due to the varying laws regarding whether residents can legally practice medicine. Otherwise, a physician subject to Open Payments includes “any of the following types of professionals that are legally authorized to practice, regardless of whether they are Medicare, Medicaid, or Children’s health Insurance Program (CHIP) providers:
- Doctor of Medicine;
- Doctor of Osteopathy;
- Doctor of Dentistry;
- Doctor of Dental Surgery;
- Doctor of Podiatry;
- Doctor of Optometry; and
- Doctor of Chiropractic Medicine.
ACTION TO TAKE NOW:
Open Payments does not require physicians to take any action. Physicians who are not concerned about their name being published on the Open Payments list of those who have received compensation from a drug/device manufacturer or GPO will not be affected at all. Those physicians should simply be ready to answer any questions about such compensation; BUT physicians who do care about the implications of Open Payments should take the following suggested steps to be aware of what information will be reported and they should actively engage in monitoring, and if necessary correcting, Open Payments reports.
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Subscribe to the CMS listserv to receive regular Open Payments Updates
It is important for physicians to note that subscribing to the listserv to receive emailed updates is a completely separate process from registering on the future Open Payments website portal to receive payment reports (see below for registration information). Once subscribed to the listserv, physicians can customize their alerts and receive notices of upcoming webinars, deadlines, and notices related to Open Payments. This step is voluntary, but important to stay abreast of the most recent information, particularly because this is the first year of Open Payment implementation.
- Understand How Open Payments Works
- Step 1: Industry payments and other transfers of value are made to physicians (see what is reportable below).
- Step 2: Companies submit data to CMS on payments and other transfers of value information. For each data submission, submitter must attest that the data is timely, accurate, and complete.
- Step 3: CMS provides a 45-day period where physicians can review and dispute reports, with an additional 15 days to allow companies to correct disputed data.
- Step 4: CMS will make data available on a public website. Data will be searchable, aggregatable, and downloadable. Disputes resolved after the initial window will be updated annually.
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Know What Information is Reportable
Physicians are not required to send or report any information to CMS. Penalties for failure to report only apply to applicable manufacturers and GPOs. Reporting Entities will categorize and report all the following types of compensation over $10 or over $100 in aggregate (the threshold amounts will raise annually with inflation):
- Consulting fees
- Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than an accredited continuing education program
- Honoraria
- Gifts
- Entertainment
- Food and beverage
- Travel and lodging
- Education
- Research (reporting can be delayed per valid company request)
- Charitable contributions
- Royalty or license
- Current or prospective ownership or investment interest (including those held by immediate family members
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Grants
There are the following exceptions:
- indirect payments where the manufacturer does not know the identity of the physician (including buffet style meals and community table refreshments);
- samples not intended to be sold that are intended for patient use (NOTE: under Section 6004 of the Act, companies will have to start reporting drug sample distribution details to the FDA, including physicians’ signatures; however, final guidance has not yet been issued);
- educational materials that directly benefit patients;
- discounts, including rebates;
- short-term loan of a medical device;
- transfers of value and payments made to a physician in return for non-physician services from the physician (e.g., physician who is also a lawyer providing legal services to an applicable manufacturer or GPO);
- Items or services provided under a contractual warranty;
- A dividend or other profit distribution, or ownership or investment interest in a publicly traded security and mutual fund;
- in-kind contributions used for charity care, and
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Speaker/faculty honoraria (including meals) for CME events that meet the following three conditions:
- The CME program is accredited by the ACCME, AOA, AAFP, AMA, or ADA; AND
- The manufacturer does not make a payment or transfer of value directly to speakers/faculty or attendees/ participants that are deemed covered recipients; AND
- The manufacturer does not select or influence the selection of speakers/faculty or attendees/participants.
For each payment, the report must contain the following information:
- The full legal name of the recipient, as listed in HHS’s National Plan & Provider Enumeration System;
- The primary business address of the recipient;
- The physician’s specialty, National Provider Identifier (NPI) number, and state professional license number (it can also include the physician’s email address);
- The amount of the payment;
- The date of the payment;
- The form of the payment (e.g., cash or cash equivalent, in-kind items or services, stock, etc.);
- The nature of the payment (e.g., consulting fees, gifts, entertainment, food, etc. – see list above);
- If the payment is related to a specific drug, the name of the drug;
- If the payment is made to an entity or individual at the request of the physician, the name of the other individual or entity that received the payment; and
- Whether the payment was provided to a physician who holds an ownership or investment interest in the manufacturer.
Update Your National Provider Identifier (NPI) Record
To comply with the administrative provisions of the Health Information Portability and Accountability Act (HIPAA), The Centers for Medicare & Medicaid Services (CMS) developed the National Plan and Provider Enumeration System (NPPES) to assign providers unique identifiers called National Provider Identifiers (NPIs). Because companies will make reports based on physician NPIs, individual physicians should update their NPI record or apply for an NPI online if they do not already have a number assigned. Physicians should ensure the address, specialty, state professional license number, and other information associated with their NPI record is correct in the system.
Track Your Payments
Reporting Entities (drug/device manufacturers and GPOs) are not required to provide physicians with pre-submission reports. Thus, if physicians want to be well-prepared to review Open Payment reports down the line, they should begin tracking all gifts, meals, etc. provided by applicable manufacturers. Even if those items are less than $10 in value, it is a good idea for physicians to still track those items, because the aggregate amount may total more than $100 at the end of the annual reporting period.
CMS has created a free mobile app, available now, that physicians can use to track payments. The app is for personal information collection and serves as a storage depository only. The app does not interact with CMS systems, but physicians may wish to use this tool to validate information submitted by manufacturers about payments made to them. CMS bills the app as “a resource to track transfers of value in real-time, as they occur throughout the year.” User profiles and transfer of value information can be shared between physician and industry apps. The app can be downloaded at the Google Play™ app store or iOSApple™ app store by searching for “Open Payments for Physicians.” Screen shots of the app are included below:
CMS will not validate the accuracy of data stored in the app, nor will it be responsible for protecting data stored in the app. Reporting entities have sole responsibility for the accuracy and completeness of the data submitted to CMS under Open Payments.
ACTION TO TAKE AFTER JANUARY 1, 2014:
Register with CMS
CMS is creating a portal as part of its Open Payments Program website where physicians can register to receive notifications when their name is included in a pharmaceutical or medical device manufacturer’s submitted report to CMS. Physicians are not required to register; however, registration is strongly suggested, because manufacturers and GPOs are not otherwise required to notify physicians of information contained in the reports. Registration will allow physicians to review information and initiate disputes before the information is made public.
Registration is not yet available, and will open sometime after January 1, 2014. Physicians that are subscribed to the CMS listserv should receive a notice when registration is open. Check the CMS website for further updates.
Ensure Accuracy of Reported Data
Once companies report the data, physicians are strongly encouraged to review the submitted reports for accuracy. Physicians will have 45 days to challenge reported information and an additional 15 days to resolve disputes before CMS publishes the information on the internet. Issues that aren’t resolved will be marked as “disputed,” and issues resolved after the 60-day period will be corrected when the data are next refreshed online, at least once annually. Payments will be listed by the date on which they are made, not according to when the event or service occurs.
Key 2013-2014 Dates:
- Data Collection (8/1/2013 – 12/31/2013)
- Physician Registration Period (early 2014)
- Data Submission by Manufacturers and GPOs (by March 31, 2014)
- Data Review, Dispute, & Correction Period (April- June 2014)
- Publication of Information on CMS Website (September 30, 2014)
Physicians should note that, during webinars targeting industry held on November 19, 2013, instead of hard dates as stated in the final rule, CMS discussed their timeline in terms of the following soft date targets, which include early 2014 submission, mid 2014 collection, and late 2014 publication of the data.
Questions?
For questions, physicians can email Openpayments@cms.hhs.gov or participate in CMS webinars or continuing education opportunities accessed through the CMS website. Two such activities are available and accessible via Medscape; both are accredited by the Accreditation Council for Continuing Medical Education:
- “Are You Ready for the National Physician Payment Transparency Program?” Physicians can receive a maximum of 1.00 AMA PRA Category 1 Credit™ by participating in the activity and receiving a minimum score of 70% on the post-test. Through the activity, participants will learn more about Open Payments, the steps involved in collecting and reporting physician data, key dates for implementation, and actions they can take to verify physician information in advance of website publication.
- “The Physician Payment Transparency Program and Your Practice” Physicians can receive a maximum of 0.25 AMA PRA Category 1 Credit™ by participating in the activity and receiving a minimum score of 70% on the post-test. Through this activity, participants will be able to identify opportunities for physicians to review transfers of value attributed to them and differentiate types of transfers of value that will or will not be reported under Open Payments.
Three regional webinars for physicians, associations, medical societies, practitioners, and practice managers were held on November 14, 19, and 20, 2013. Webinar leader and CMS employee, Louisa Carey told Policy and Medicine that approximately 440 participants joined the November 19th webinar, indicating strong physician interest in learning more about Open Payments. CMS Public Information Officer, Jack Cheevers reported that CMS was generally “pleased with the level of participation to date.”
Carey stated that physicians can participate in the follow-up Q&A webinar scheduled for December 3, 2013 from 1:00-3:00 pm, although the target audience is industry. Based on demand, Carey stated that the regional webinars will be available in the future for download, along with already-posted “What You need to Know” sessions recorded previously in May 2013 and August 2013. Check back at the CMS Open Payments Events site for updates.
Conclusion
Policy and Medicine has created a convenient Open Payments: Quick Facts for Physicians one-pager that summarizes key Open Payments information for physician reference. If physicians are well-versed regarding the nature of Open Payments data, they will be in a position to educate patients and place physician-industry relationships in a positive light.
Although the recent QPharma Survey revealed that 41% of PCP’s don’t know whether informing patients about the meaning of the Open Payments data will give patients a positive understanding of the publicly reported information, another 16% of PCPs think it could help “a lot.” Specialists are more pessimistic about Open Payments patient education. Only 6% think it would help “a lot,” while 25% think it won’t help at all. Nevertheless, 44% of specialists believe that educating patients about the meaning of Open Payments data could “somewhat” help provide a positive understanding of the data.
In discussing the perception of Open Payments data, ACP Internist noted that “[p]eople shouldn’t view being on this website as a ‘list of shame’, [according to Neil Kirschner, PhD, the American College of Physicians’ senior associate for health policy and regulatory affairs] . . . The fact that there is a relationship between industry and physicians is itself not a bad thing…It’s appropriate for doctors to learn things, to consult, and to get grant money from industry. If it’s out in the open it takes away the more nefarious potential or impression.” ACP Internist also noted that Kirschner believes the publicly available information could increase trust between patients and physicians.
Thus, after ensuring a complete understanding of Open Payments through resources provided by CMS, Policy and Medicine, the AMA, and others, physician practices may want to consider creating a bulletin board poster or one-page brochure for patients that highlights the following information about physician-industry relationships and Open Payments:
- Relationships between industry and physicians foster innovation and development and improve the quality of patient care;
- Industry-sponsored medical education keeps physicians informed about the newest devices and pharmaceutical treatments, and these interactions are regulated by accrediting bodies including the Accreditation Council for Continuing Medical Education and the American Medical Association;
- Open Payments is a government-administered website that provides transparency by simply listing direct and indirect payments made to physicians as reported by pharmaceutical companies and medical device manufacturers;
- All individual transactions valued over $10, or several smaller transactions totaling over $100, are reported by companies (including meals, speaker fees, textbooks, raffle prizes, travel reimbursement, etc.);
- Payments reported by companies do NOT indicate wrongdoing or affect independent physician judgment; and
- If a patient has concerns about Open Payments data, the physician welcomes questions.
Physicians may even want to personalize patient education to include any research or ongoing consulting/speaking relationships they participate in, highlighting those relationships as evidence of their expertise. Proactive patient education can help frame Open Payments so that physicians do not sever industry ties out of concern that Open Payments data will be misinterpreted. Patient education is key to avoid the potential “chilling effect” of Open Payments on the relationship between physicians and industry. Ideally, the Open Payments website will be viewed simply as another level of transparency that consumers and citizens have come to expect across all sectors.
Important Links for Physicians:
Open Payments: Quick Facts for Physicians
CMS Open Payments Events (webinars, calls, meetings)