2014 has been a big year for the Physician Payments Sunshine Act. Applicable manufacturers submitted their 2013 payment data in two phases, then physicians and teaching hospitals were able to engage in review and dispute during the summer, and on September 30, the Centers for Medicare and Medicaid Services (CMS) published the Open Payments data. While this timeline glosses over the technical difficulties, data problems, and missing payments in the system, companies don’t have time to dwell on Open Payments’ rocky rollout—reporting obligations have not stopped. Companies must move forward to submit their 2014 reports to CMS next year.
Policy and Medicine has been writing about the Physician Payments Sunshine Act for a long time now. Below is a summary of our articles about the Act since CMS announced the final rule. This will serve as an ongoing reference for articles related to the Sunshine Act.
In light of the significant complexity the rule presents to many stakeholders, we provide a condensed chart or quick reference guide for readers to know many of the key details for reporting.
A brief overview of key areas of Sunshine compliance
A listing of client alerts and other analysis from law firms and industry regarding the final regulations.
Questions and Answers
A complete list of up to date Questions and Answers for Open Payments compiled by topic category in an easy to access format. According to CMS they have received over 500 Q&A that they are hoping to answer.
We have also provided analysis of many of the FAQs as they have been released:
Open Payments Data Release
Search for physicians, teaching hospitals, and applicable manufacturers. Currently, the database is missing a fair amount of physician-identified information. However, this is poised to change in 2015.
Out of the 2.6 million lines of identifiable general payments that manufacturers collected and reported to CMS about their interactions with physicians and teaching hospitals, approximately 1.7 million "transfers of value" were for less than $20. More than 1.2 million were for less than $15.
With the release of the Open Payments database, many were concerned that the benefits of this partnership would be lost in the discussion. After all, Open Payments provides little room for context, and is essentially just a spreadsheet of payment transactions. While some media outlets did take the Open Payments release as an opportunity for a witch hunt, others dug deeper into the numbers. A Michigan news source interviewed the five Michigan doctors with the highest payment totals, and gave each an opportunity to discuss the fruits of collaboration.
The media surrounding the release for the most part focused on the deficiencies in the roll out of the system. This article also lists resources that analyzed the payment data. We followed up this initial publication review with another round-up on October 30, a month after the initial data release.
Research payments from manufacturers to teaching hospitals and physicians in the first database were around $1.5 billion. While about 90 percent of this research data was de-identified, so as to cover the recipient of these payments, the information provides a useful look into the collaborations between companies and physicians and teaching hospitals.
Continuing Medical Education
On October 31, CMS released their updated final rule containing modifications to the Open Payments program. The rule eliminated the continuing education exclusion formerly located at 42 C.F.R. Section 403.904(g)(1). However, this change effectively incorporates the exclusion into other language in the rule, and may actually broaden the exclusion for continuing education payments because the now-eliminated provision had required that the event be accredited or certified by certain organizations. Read a simple breakdown of the new CME treatment here.
The tremendous support for a CME exemption in the Sunshine Act was evident in the rulemaking process where hundreds of comments were submitted encouraging the agency to either maintain or expand the current exclusion. This article compiles the organizations comments on the issue.
Reps. Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements.
At a November 2014 meeting in Washington, D.C., Rep. Michael Burgess, M.D. (R-TX) spoke to the importance of H.R. 5539, bipartisan legislation he co-sponsored that would exempt peer-reviewed medical journal reprints and independent continuing medical education from Sunshine Act reporting.
The CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities.
CMS Resources: Reporting Requirements and Data Submission Information
CMS outlines the entities that must report under the Open Payments system.
CMS’s 361-page user guide to using Open Payments.
CMS offers insight into the Nature of Payments category that manufacturers must classify payments as.
2015 Reporting Year: Teaching Hospital list for 2014 Data Submission
CMS's annual list of reportable teaching hospitals.
Doug Brown, the acting director of the data sharing and partnership group within the Center for Program Integrity at CMS, spoke on a number of topics that compliance professionals have spent the last year working through. He also touched on what to expect in 2015.
Payments website to include fact sheets for applicable manufacturers, applicable group purchasing organizations (GPOs), teaching hospitals and physicians who will be affected by the Open Payments, commonly known as Sunshine, final rule.
Physician Resources and Dispute Resolution
CMS outlines the registration process for covered recipients interested in viewing and potentially disputing payments before they are published.
This summer, the Centers for Medicare and Medicaid Services (CMS) issued a call for comments on the Dispute Resolution process for Open Payments, the program to implement the Physician Payments Sunshine Act. CMS received 38 responses, many of which revealed the tension inherent in the Act between doctors and pharmaceutical and device manufacturers.
Cost, Impact, and Controversy
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a report titled Improvements Needed to Ensure Provider Enumeration and Medicare Enrollment Data Are Accurate, Complete, and Consistent. The report cites multiple failings in the reliability of the data contained in the National Plan and Provider Enumeration System (NPPES) and the Provider Enrollment, Chain and Ownership System (PECOS).This report is of particular interest because one of the main requirements under the reporting provisions of the Sunshine Act is that manufacturers and GPOs report a physician's name, address, NPI number, and other identifying information all based on information in the NPPS database.
The Sunshine Act's administrative burdens add yet another hurdle for life science companies, especially those smaller in size, in their efforts to save lives.
We looked at the costs CMS has estimated the Sunshine Act will have on affected stakeholders—doctors, hospitals, and manufacturers—as well as the regulatory impact analysis CMS conducted in issuing the regulation.
This article outlines the Disclosure Code, approved by EFPIA on June 24, 2013.
The Japanese pharmaceutical industry has been tracking and reporting transfers of value to healthcare professionals and academic centers based in Japan. In this article, we walk through the provisions of the Japanese transparency guideline before looking at the payment data and corresponding news stories surrounding the recent release of that data.
The Colombia Ministry of Health and Social Protection recently published a draft law which would require pharmaceutical and device manufacturers to disclose their payments and in-kind transfers to “those who participate in any manner in the provision, insurance, or education in the health sector.” The reports will be made public on a searchable database.
Medicines Australia, Australia's industry body, recently revamped the disclosure provisions of its Code of Conduct, and sent the reforms to the Australian Competition and Consumer Commission (ACCC) for approval. The new Code will require Medicines Australia's member companies to report on an individual basis a wide range of payments and transfers of value to healthcare professionals, as well as sponsorships of third party educational meetings and symposia. The Australian requirements are similar to the United States' Physician Payments Sunshine Act, but there are notable differences in the policies.
The Loi Bertrand, or the French Sunshine Act, is similar in many ways to the US Physician Payments Sunshine Act, but even more expansive. These differences pose significant hurdles for companies attempting to build uniform programs to comply with these laws. Furthermore, the French Sunshine Act's disclosure obligations are retroactive to transactions occurring in 2012.
Minnesota had updated its statute to require manufacturers report their payments to physician assistants, nurse practitioners, veterinarians, and dental therapists.
A new Connecticut law requires pharmaceutical and device companies to report payments made to advance practice registered nurses.
We run down the list of reporting requirements for the unique state disclosure laws that are out there. Minnesota and Connecticut have since been updated.
CMS stated that they may share their information with other government bodies if CMS determines that "the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court, or adjudicatory body is compatible with the purpose for which the agency collected the records."
The Sunshine Act requires data to be searchable and "easily aggregated and downloaded." Sunshine data could instantly provides qui tam attorneys a host of information that would have been impossible or very difficult to find before the Act.
Tools and Systems