On April 24, 2013 the AMA presented the webinar "Physicians Preparing for the Sunshine Act: What You Need to Know and How to Prepare." The archived broadcast and slidedeck for this webinar are now available.

Speakers:
Jeremy Lazarus, MD - President/AMA
Sylvia Trujillo, MPP/JD - Legislative Counsel/Senior Attorney/AMA

This webinar will help you:

• Identify the two central provisions of the Sunshine Act including the (1) financial interactions that are subject to reporting; (2) the ownership interests that are subject to reporting.
• Identify the major financial interactions and ownership interests that are excluded from reporting.
• Initiate and complete key steps to prepare for reporting that will begin on August 1, 2013.
• Identify and utilize resources that are available to ensure that reportable financial interactions between a physician and industry and ownership interests are accurately and fairly reported.

There are many interactions between physicians and manufacturers of drugs, medical devices, and medical supplies that benefit patients and advance the art and science of medicine. The Sunshine transparency reports provide patients and the public with information on the financial interactions of physicians and industry. These interactions often drive innovation, discovery, and changes in medical practice that may promote better patient outcomes. The congressional sponsors of the ACA reporting provisions have stated that this process is not designed to stop, chill, or call into question beneficial interactions between physicians and industry, but to ensure that they are transparent.

Financial Transfers:

• Direct. Manufacturers of a drug, device, biological, or medical supplies participating in federal health care programs will have to report to CMS any direct payments or transfers of value to physicians and/or teaching hospitals of $10 or more. However, there are 12 exceptions where a direct payment or transfer of value is not subject to reporting. These include product samples and educational materials that directly benefit patients.
• Third Party. There are certain transfers, not made directly to physicians, that are subject to reporting (called indirect transfers). Transfers or payments that the physician specifies should be given or paid to another person or entity would be reportable, so too would any transfer or payments that another person indicates are being made on behalf of the physician. CMS requires reporting even though a physician does not receive the payment or transfer.
• Indirect. Another reportable indirect transfer includes when manufacturers make a payment to a third party, such as physician organization, and then requires, instructs, or directs the payment or transfer of value to be provided to a specific physician or intended for physicians (in the latter case without regard to whether specific physicians are identified in advance).

Ownership:Manufacturers and GPOs participating in federal health care programs will have to report to CMS certain ownership interests held by physicians and their immediate family members. However, there are certain ownership interests, such as securities which may be purchased on terms generally available to the public and which are listed on a stock exchange in which quotations are published on a daily basis, which are not reportable ownership interests.

Review & Public Reports: The majority of the information contained in the transparency reports will be available on a public, searchable website. By statute, physicians are provided, at a minimum, 45 days to review their own consolidated transparency report and make corrections before the report is made public. Physicians have additional time, cumulatively two years, to dispute reports even after the reports are made public. If a physician utilizes the dispute process, the public data will be marked as disputed in the public database.

• August 1 through December 31, 2013: Manufacturers are required to begin collecting and tracking payment, transfer, and ownership information. Thereafter, they are required to report for each full calendar year.
• January 1, 2014: We anticipate that CMS will launch the physician portal that allows physicians to sign-up to receive notice when their individual consolidated report is available for review. This portal will also allow physicians to contact manufacturers/GPOs if they want to dispute the accuracy of a report.
• March 31, 2014: Manufacturers/GPOs will report the data for 2013 to CMS.
• June 2014: We anticipate that CMS will provide physicians access to their individualized consolidated version of all manufacturers/GPO reports for the prior calendar year in June 2014. Physicians may access the consolidated reports via an online website portal maintained by CMS and will be able to seek correction or modification by contacting the manufacturer/GPO through the portal.
• September 30, 2014: CMS will release most of the data on a public website.

Your patients may wish to know whether you have or have had financial interactions with industry. When a patient asks about this topic, it is important that you discuss the matter candidly in a way that will enhance the patient’s understanding without compromising trust or the patient-physician relationship. Some of the issues you might want to address with the patient are what sources you rely on for information about medical innovations and new evidence, your role in medical research, and how you believe research will improve outcomes for patients.p>

What is being reported?
Payments, transfers of items that have value, and ownership interests.

• Payments and Transfers of Value: Manufacturers must report payments and "transfers of value" made directly to physicians and teaching hospitals. Manufacturers are required to describe how the recipient received the payment such as cash or cash equivalent, in-kind items or services, or stock, stock option(s), or any other ownership interest, dividend, profit, or other return on investment. In addition, manufacturers must specify the nature of the payment or transfer of value. There are 14 possible categories including, for example, consulting fees, grants, research, honoraria, and charitable contributions. In addition to direct payments, manufacturers must report certain payments and transfers of value that are made indirectly to a physician or that are made to a third party as requested by a physician or designated as being made on behalf of the physician.
• Ownership Interests: Manufactures as well as GPOs are required to report on ownership interests held by physicians and their immediate family members. The transparency report must include the dollar amount invested, the value, and terms of ownership or investment interest, and any payment provided to physician owner or investor. However, there are certain ownership interests, such as securities which may be purchased on terms generally available to the public and which are listed on a stock exchange in which quotations are published on a daily basis, which are not reportable ownership interests.

What is exempt from reporting?

• Certified and accredited CME.
• Buffet meals, snacks, soft drinks, or coffee generally available to all participants of large-scale conference or similar large-scale events.
• Product samples that are not intended to be sold and are intended for patient use.
• Educational materials that directly benefit patients or are intended for patient use. CMS narrowly interpreted this exemption. Textbooks and reprints are not excluded under this provision.
• The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
• Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
• A transfer of anything of value to a physician when the physician is a patient and not acting in his or her professional capacity as a physician.
• Discounts (including rebates).
• In-kind items used for the provision of charity care.
• A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund.
• In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan.
• In the case of a physician who is a licensed non-medical professional, a transfer of anything of value to the physician if the transfer is payment solely for the non-medical professional services of such licensed non-medical professional. For example, payments to a physician who is licensed to practice law and who is retained by a manufacturer to provide legal advice would not be subject to reporting.
• In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the physician with respect to a civil or criminal action or an administrative proceeding.
• A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the manufacturer during the calendar year exceeds $100, subject to increase each year using the consumer price index.

Who has to report?

• Manufacturers must submit the reports on payments and transfers of value to CMS on an annual basis.
• Manufacturers and GPOs must report ownership interests held by physicians and their immediate family members.

Do the reports document unethical, fraudulent, or illegal interactions?

• Congress did not intend for the Sunshine Act reports to reflect unethical, fraudulent, or illegal interactions.
• Instead, it was to create transparency.
• Just as there are rules that require public meetings for public officials, the transparency similarly shines a light on interactions to ensure that these interactions advance the best interest of patients and advance the art and science of medicine.

What type of payment and transfer of value information will manufacturers report?

• Manufacturers are required to categorize how the recipient received the payment (such as cash or cash equivalent, in-kind items or services, or stock, stock option(s), or any other ownership interest, dividend, profit, or other return on investment).
• Manufacturers must provide a reason for the payment. There are 14 possible categories including, for example, consulting fees, grants, research, honoraria, and charitable contributions.

What type of ownership interest is reported?

• Manufacturers as well as GPOs are required to report on interests held by physicians and their immediate family members.
• The transparency report must include the dollar amount invested, the value, and terms of ownership or investment interest, and any payment provided to physician owner or investor.
• However, ownership or investment interests in publicly traded security and mutual funds are excluded.

What are the 14 possible categories manufacturers are required to use to describe the nature of payments or transfers of value?

• Consulting fees
• Compensation for services other than consulting
• Honoraria
• Gift
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contribution
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a speaker for a medical education program
• Grant

How do I find out about what industry is reporting about me?

• CMS will have a website where you will be able to check a consolidated report at the end of the annual reporting period.
• However, you should check with any manufacturer from which you have received payment or any item of value to see what information they are tracking and intend to report.
• If you hold any ownership interests in a manufacturer or GPO, you should also check to ascertain what ownership interest(s) they intend to report. (Ownership or investment interests in publicly traded security and mutual funds are excluded from reporting.)

What do I do if the information reported about me is wrong?

• Physicians will have at least 45 days once CMS provides access to individual physicians’ consolidated industry reports via an online portal to challenge reports. The portal will allow physicians to contact the manufacturer(s)/GPO(s) that submitted inaccurate, misleading, false information in order to resolve disputed submissions.
• If a physician and manufacturer(s)/GPO(s) cannot resolve the dispute, they are provided an additional 15 days before the report is made public to try to achieve resolution.
• If resolution is still not reached, the disputed information will be flagged, but the report will be posted on the public webpage CMS develops for all transparency reports.
• Physicians are also able to seek correction or contest reports for two years after access has been provided to a report with disputed information.
• Once CMS establishes the online portal, physicians will be urged to sign-up to receive direct notice when the reports are made available to physicians prior to CMS posting on the public website.

• Physicians will have at least 45 days once CMS provides access to individual physicians’ consolidated industry reports via an online portal to challenge reports. Access will not occur until after the calendar year has come to a close. The portal will allow physicians to contact the manufacturer(s)/GPO(s) that submitted inaccurate, misleading, false information in order to resolve disputed submissions.
• If a physician and manufacturer(s)/GPO(s) cannot resolve the dispute, they are provided an additional 15 days before the report is made public to try to achieve resolution.
• If resolution is still not reached, the disputed information will be flagged, but the report will be posted on the public webpage CMS develops for such reports.
• Physicians are also able to seek correction or contest reports for two years after access has been provided to a report with disputed information.
• Once CMS establishes the online portal, physicians will be urged to sign-up in order to receive direct notice when the reports are made public.
• You should check with any manufacturer from which you have received payment or any item of value to see what information they are tracking and intend to report.
• If you hold any ownership interests in a manufacturer or GPO, you should also check to ascertain what ownership interest(s) they intend to report. (Ownership or investment interests in publicly traded security and mutual funds are excluded from reporting.)

Prior to the ACA, however, several states enacted “sunshine” type laws. It is important for physicians to recognize that the federal Sunshine Act, when fully implemented, may create additional requirements for physicians in states that already have a state law. In states where there is no state law, federal law will govern. If a state is not listed in this chart, please consult with your state medical society for specific guidance. The AMA will update this chart as new information becomes available.

CMS is required to provide information on the annual transparency reports to physicians before the reports are made public. It is anticipated that CMS will have an online portal that physicians will be able to use.  When the link is available, it will be posted here.

CMS is required to provide most of the information contained in the transparency report in a public Webpage. When the link is available, it will be posted here.

The AMA along with 49 medical specialty societies and 43 state medical associations, submitted a sign-on comment letter on the proposed rule. In addition, the AMA joined a sign-on letter submitted by national organizations involved in Continuing Medical Education (CME) in the United States, including Accreditation of CME Providers, granting of CME Credit for CME activities, and fulfillment of the responsibility of the Profession of Medicine to self-regulate in the arena of CME.

April 26, 2013 letter to CMS re: Sunshine Act Final Rule Recommended Guidance on Reprints

April 9, 2013 letter to CMS regarding Reports of Physician Ownership and Investment Data Collection

Physician Payments Sunshine Act – Overview & Key Provisions

October 10, 2012 AMA comments to CMS as follow-up to Senate Special Committee on Aging Roundtable

February 17, 2012 AMA sign-on comment letter to CMS

February 16, 2012 CME Provider sign-on comment letter to CMS

April 8, 2011, AMA Comments to CMS

The AMA has long supported efforts to promote transparency in the interactions of physicians and industry. Beyond reporting transfers of value, the AMA believes that physicians’ relationships with industry should always be transparent, meaningfully independent, and focused on benefits to patients. This includes providing information physicians and the public need to make informed, critical judgments about interactions with industry and taking steps to ensure that physicians’ clinical judgments are objective and evidence based. AMA policy also endorses transparency and independence. The AMA has also sought to refine the provisions of the Sunshine Act in the interests of patients and physicians. Newly adopted policy commits AMA to continuing efforts to ensure that the burden on physicians is minimized and that CMS does not expand the Sunshine Act without appropriate authorization by Congress, as well as urging CMS to provide for a physician comment section on its public database. (H-140.848 Physician Payments Sunshine Act; see Additional AMA Policy.)