Pharmaceutical and device manufacturers have been busy working through the first reporting year under the Physician Payments Sunshine Act. June 30, 2014 marked the deadline for companies to submit detailed reports to the Centers for Medicare and Medicaid Services (CMS) regarding payments and items of value given to physicians and teachings hospitals during 2013. On September 30, 2014, CMS will publish the majority of the information contained in these reports on a searchable website.
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.
A review of the nature of payment categories and how they apply towards company reporting.
An analysis of the Reporting Requirements under the sunshine act final rule.
Physician Payment Sunshine Act Final Rule: 45 Day Review Period and Penalties. Applicable manufacturers, applicable group purchasing organizations, covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to the information submitted for a period of not less than 45-days before CMS makes the information available to the public. In no case may this 45-day period for review and submission of corrections prevent the information from being made available to the public.
Several key pieces of information regarding physician ownership/investing and the Physician Payment Sunshine Act.
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:
CMS released the CY 2015 Medicare Physician Fee Schedule proposed rule in July 2014. The 609-page document proposes a number of changes to the Physician Payments Sunshine Act, including deleting the specific exemption for payments made to speakers at accredited CME events. CMS stated that they propose to remove the specific exclusion, CME payments may still fall under the Sunshine Act's "Indirect Payment" Exclusion.
The CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities.
The American Medical Association (AMA) House of Delegates overwhelmingly passed two crucial proposed changes to the Physician Payments Sunshine Act. The first recommendation is for the Sunshine Act to include a reporting exclusion for educational items including medical textbooks and peer-reviewed journals. The second is to limit the Sunshine Act reporting requirements to reporting transfers of value over $100.
Congressman Robert E. Andrews (D-1st District, New Jersey) requested that CMS exempt from individual reporting the cost of all food served at CME events for CME speakers/faculty and for CME attendees. The rule already exempts speaker/faculty honoraria, including meals, from qualifying CME events that meet certain conditions.
On July 3, 2014, CMS released the CY 2015 Medicare Physician Fee Schedule proposed rule. The 609-page document included a number of proposed changes to the Physician Payments Sunshine Act – Open Payments final rule.
A user-friendly resource for other stakeholders regarding important information and dates that the Centers for Medicare & Medicaid Services (CMS) is providing through their Open Payments webpage. CMS has provided several easy to follow charts with important dates and brief descriptions that will provide a useful reference to all stakeholders.
Congressional lawmakers are working to eliminate the Physician Payment Sunshine Act (Open Payments) requirement that applicable manufacturers (pharmaceutical, device and biologic) disclose gifts of medical journals and textbooks to physicians.
Several states, including Vermont and Massachusetts, have additional reporting requirements above and beyond the Sunshine Act. We compiled a list of these disclosure states.
At the urging of the Minnesota Board of Pharmacy, the Minnesota legislature passed HF 2402, which one section requires drug manufacturers to report payments to physician assistants, APRNs, and dental therapists. These entities are excluded from the Federal Physician Payments Sunshine reporting obligations.
Massachusetts Gift Ban Update, June 2014
In 2009, the State of Massachusetts enacted the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC), which requires companies to report payments of more than $50 made to any healthcare practitioner. The law has provided a foreshadowing of the Federal Physician Payments Sunshine Act, which came into effect August of 2013.
A new Connecticut law requires pharmaceutical and device companies to report payments made to advance practice registered nurses (APRNs). The revised bill makes the payments made to APRNs reportable after July 1, 2015, instead of January 1, 2015. It also allows the commissioner of the Department of Consumer Protection, instead of the Department of Public Health, to publish the information on his department's website.
District of Columbia's AccessRX Act of 2004 has required pharmaceutical companies to report their marketing activities in DC for almost a decade now. D.C. publishes spend data every year—a report we have followed closely. However, this year, in light of the Physician Payments Sunshine Act, the DC Department of Health will not require companies to report gifts made to physicians and teaching hospitals between August 1 and December 31, 2013. Reporting requirements for aggregate and advertising expenses remain unchanged.
Under the Physician Payment Sunshine Act Final Rule, certain research payments or other transfers of value made to a covered recipient by an applicable manufacturer under a product research or development agreement may be delayed from publication on the website.
List of Teaching Hospitals
CMS has stated that it will publish a list of the relevant teaching hospitals "at least 90 days before the beginning of the reporting year, or for the first reporting year, at least 90 days prior to the start of data collection."
2013: Physician Payment Sunshine Act: CMS Releases List of Teaching Hospitals for 2013 Reporting Period
Open Payment Resources
The Centers for Medicare & Medicaid Services (CMS) published a "User Guide for Industry" regarding its Open Payments program—also known as the Physician Payments Sunshine Act. Interestingly, the subtitle of the guide is, "Creating Public Transparency Into Industry-Physician Financial Relationships."
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.
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.
CMS held a conference call regarding the implementation of its Open Payments program, outlining some updates and summaries of the final Sunshine Rule.
Physician Resources and Dispute Resolution
CMS provided a broad overview of the steps covered recipients must take to register with EIDM and Open Payments. They also released a 75 page PowerPointfor physicians and teaching hospitals, introduced new FAQs and their latest timeline, and released a 196 page Open Paymentsuser guide.
The CBI Compliance Congress offered insight into how industry has approached Sunshine Act reporting. The presentation "Strategies for Dispute Resolution and Dispute Processes," focused on how to comply with rigorous reporting obligations with limited company resources, transitioning the Sunshine Act from the compliance department to the overall business, internal certifications, and what companies are doing to prepare for physician inquiries and disputes.
Last month, 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 and Impact
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.
Radiologists need to care because the Sunshine reports may not paint an accurate picture. For example, a manufacturer may report a $50,000 grant in the travel or the research category, leading to misperception issues.
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.
Starting in 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies will make public the details of payments and transfers of value made to healthcare professionals (HCPs). The first disclosures will be made in 2016 and will convey information about payments made in 2015. As companies prepare for reporting, EFPIA has launched a new website to highlight the new disclosure rules, follow best practices in the implementation of EFPIA's Code, and monitor compliance in the 33 countries involved in the initiative.
This article examines the inconsistencies among member country codes.
In a recent client alert from the law firm Debevoise & Plimptom, LLP, several attorneys discussed the potential international implications that can affect physicians and manufacturers in light of the finalized Physician Payment Sunshine Act regulations.
Pharmaceutical manufacturers operating in Europe must disclose payments made to physicians starting in 2016 in an effort to boost transparency and make patients aware of possible conflicts of interest.
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.
The Eighth International Pharmaceutical Compliance Congress took place in Dubai, UAE from May 5-7. The conference featured many useful programs and impressive speakers that highlighted how compliance is an increasingly global challenge. The Organization of Pharmaceutical Producers of India (OPPI), an association of research and innovation driven pharmaceutical companies, offered insight into the compliance landscape in India.
As life sciences companies continue to expand their footprint in many emerging markets, they will have to grapple with the impact of external economic factors on the Fair Market Value (FMV) of the payments they make to physicians they engage with in those markets.
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.
A recent article written by Kelly M. Cleary, a lawyer from Akin Gump Strauss Hauer & Feld, discussed some of the potential federal and state healthcare fraud issues that may be implicated by the Sunshine Act.
Tools and Systems
CMS released important materials to assist reporting entities with the technical aspects of the data submission process.
The Centers for Medicare and Medicaid Services (CMS) released their Open
Payments Apps for Physicians and Manufacturers/GPO's to help keep records for Physician Payment Sunshine Act reporting. The Open Payment Mobile for Physicians, provided free by CMS (IPhone and Android) is intended to help both physicians and members from industry keep track of, store, and view financial payments and other transfers of value as required by the Physician Payment Sunshine Act and its implementing regulations.
The Office of Management and Budget (OMB) posted documents that provide a lot of insight into the next steps of the Open Payments System for implementing the Physician Payments Sunshine Act. "Screen Shots Submission Flow," contain screen shots of a sample user submitting a "General payments" record (as opposed to Research payments or Investment/Ownership Interests).
The American Medical Association reminds physicians to update their disclosures.
Health IT company RxVantage hosted a webinar with Randy Vogenberg, managing principal at consulting firm Bentelligence, to address some common questions posed by physicians and share best practices, The thirty minute presentation offers several tips.
The New England Journal of Medicine (NEJM) devoted several articles to the Sunshine Act.