The American Medical Association (AMA) recently added resources for physicians to its Advocacy Page regarding the Physician Payment Sunshine Act. The Sunshine-dedicated page provides useful information for AMA members and physicians. Below is a brief summary of each of these Sunshine topics and links to other information and resources.
We recently noted, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), along with several other notable professional medical associations—including the American Association of Neurological Surgeons (AANS), the American College of Preventive Medicine (ACPM), the American Osteopathic Association (AOA), the American Urological Association (AUA), and the Congress of Neurological Surgeons (CNS)—launched a new initiative know as the Partners for Healthy Dialogues. The initiative, which was launched largely in response to the Sunshine Act is designed for patients, health care professionals, and biopharmaceutical representatives,
The purpose of transparency reports
We have written numerous times about the purpose and background of Sunshine, but in general, manufacturers will have to generate reports about payments they make to physicians and teaching hospitals, which CMS will then publish on a public website. The 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,” AMA writes.
Summary of key provisions of the Sunshine Act
AMA provides a very brief list of provisions, but we’ve listed our stories below about specific provisions for readers:
– Top 50 Things to Know About the Final Sunshine Act Regulations
– Final Sunshine Rule and Continuing Medical Education (CME)
– Payments Related to Research and Delayed Publication
– 45-Day Review Period and Penalties
– Cost and Regulatory Impact Analysis
– Nature of Payment Categories
– Final Sunshine Act Regulations: Definitions
Key Dates
- 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.
- March 31, 2014: Manufacturers/GPOs will report the data for 2013 to CMS.
- August 2014: CMS is required to provide physicians with a consolidated version of all manufacturers/GPO reports for the prior calendar year by mid-August of the subsequent calendar year. For the 2013 abbreviated reporting period, consolidated reports must be made available by August 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.
Being Trasnparent with Your Patients
“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.”
Frequently Asked Questions (FAQs)
This section gives information on the following FAQs:
- What is being reported
- What is exempt/excluded from reporting
- Who has to report
- What types of payments/transfers of value will be reported
- What type of ownership interest is reported
- A list of the Nature of Payment categories to describe payments
- Information about the 45-review, correction and dispute process
One FAQ asks, “Do the reports document unethical, fraudulent, or illegal interactions?” In response, AMA wrote that “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.”
How to Challenge False, Inaccurate, or Misleading Reports (the 45-day review and 15-day correction period)
AMA explained that 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. noted that 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.
AMA noted that 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. AMA recommended that physicians “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.)”
State Sunshine Laws
AMA also provided a useful resource to physicians about the several states that have enacted “sunshine” type laws prior to the federal Sunshine Act. AMA noted that 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. Accordingly, the AMA provided a useful chart of state laws, and noted that physicians should consult with your state medical society for specific guidance. The AMA will update this chart as new information becomes available.
Physician Portal – Transparency Reporting
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, AMA will posted it here.
Public Webpage – Transparency Reporting
AMA will provide the link to the public webpage CMS creates for posting payment reports.
AMA Advocacy to Ensure Fair & Accurate Reporting
Here, AMA posted many of letters, comments, and other analysis of the Sunshine Act.
AMA Policy and Principles
AMA explained its long support of 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 also explained that its policy “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.)”