CMS announced that the agency “will consider the public comments received [on the Open Payments / Sunshine Act program] in the future through possible rulemaking or publication of subregulatory guidance” in the recently released “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.” But for now, CMS … Continue reading
CMS announced that it has updated the Sunshine Act / Open Payments dataset to reflect (1) changes made to records, (2) changes to delays in publication flags, (3) changes to disputed records, and (4) deleted records. … Continue reading
A bipartisan Senate bill (S. 2153) introduced this week would expand reporting obligations under the Sunshine Act / Open Payments program to cover payments or other transfers of value provided to physician assistants and nurse practitioners. Right now, pharmaceutical and device manufacturers report on only their physician financial relationships, which could give rise to … Continue reading
On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals. The data covers 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals. Join us on July 8 or July 14 for a … Continue reading
This week at an enforcement panel, government representatives discussed using the Sunshine Act data to delve into allegations of kickbacks to doctors and detect industry trends of improper behavior. During the American Conference Institute’s 7th Annual Forum on Sunshine Act Compliance & Aggregate Spend Reporting, government representatives recognized that industry payments to physicians may be … Continue reading
CMS has released data sets showing payments to hospitals and physicians for calendar year 2013: the same calendar year as the Sunshine Act data released last fall. As a result, various sources will have contemporaneous data that could be used to suggest links between industry payments to healthcare providers and their practices, or to otherwise … Continue reading
This week, the OIG published its Mid-Year Update to its 2015 Work Plan, which we previously summarized. The Mid-Year Update adds several new monitoring activities to the existing Work Plan, summarized below. review of financial interests reported under the Sunshine Act: The OIG plans to review the number and nature of financial interests that were reported … Continue reading
Yet another set of data for your risk analysis: on April 30, 2015, the CMS released a 23-million record data set from Medicare’s Part D Prescriber Public Use File. While other CMS data sets have focused on provider remuneration (whether paid by manufacturers or Medicare itself), the Part D data focuses on physicians’ and other practitioners’ prescribing … Continue reading
Beyond the United States’ Physician Payments Sunshine Act reporting requirements, international pharmaceutical and device companies must account for a growing number of transparency requirements related to their interactions with healthcare professionals. For example, in France, the Bertrand Act requires transparency related to: (1) the agreements between companies and healthcare professionals (HCPs) and (2) any benefits, … Continue reading
Physicians and teaching hospitals can begin reviewing the Sunshine Act data attributed to them by applicable manufacturers on Monday, April 6. The 2014 data – the first full year of reported data – was due on March 31. Physicians and teaching hospitals can register in both the CMS Enterprise Portal and the Open Payments system to review … Continue reading
Starting today, applicable manufacturers and GPOs can begin submitting data about Sunshine Act payments and transfers of value for the 2014 calendar year, according to a listserv email from CMS. Applicable manufacturers and GPOs can also submit corrected 2013 data, as needed, until the March 31, 2015 deadline for data submission. Physicians and teaching hospitals … Continue reading
The shifting guidance on whether the industry should report mere funding of educational events, the likely enforcement ahead by federal and state agencies, and maps showing the “hotspots” of consulting, food and beverage, and travel and lodging payments: here’s what you should know now about the Sunshine Act / Open Payments database. The indirect-payment exclusion … Continue reading
CMS has finalized four revisions to the Sunshine Act (Open Payments) regulations as part of the 2015 Medicare Physician Fee Schedule Final Rule. These revisions are effective as of October 31, 2014, and will be implemented for the 2016 program year, with reporting to CMS in 2017. Importantly, CMS has removed the exclusion for continuing … Continue reading
Entities that submitted Sunshine Act reports are now able to review and correct the 2013 “Open Payments” records returned from the intermingled data fix that resulted in CMS withholding a significant portion of the data. The agency expects the corrected intermingled data—which accounts for approximately a third of the Open Payments database – to be … Continue reading
In the United States, the healthcare industry is familiar with the Sunshine Act’s tracking and reporting requirements related to payments and transfers of value to physicians, as well as to physician ownership and investment interests. And around the world, new rules and policies are seeking to increase transparency. For example, the Norton Rose Fulbright’s UK briefing, … Continue reading
The “Open Payments” database of transactions reported under the Physician Payments Sunshine Act has launched on its scheduled release date of September 30 and is now available for public review. Pharmaceutical and medical-device manufacturers reported information about their financial relationships with physicians and teaching hospitals for the second half of 2013 to the Centers for … Continue reading
Despite extending the dispute-and-resolution deadline to account for the days that the Centers for Medicare & Medicaid Services (CMS) pulled down the reporting system, the public Physician Payments Sunshine Act website is still expected to go live in a matter of weeks. It now seems, however, that CMS will publish only two-thirds of the reported … Continue reading
On Friday, July 11, the Centers for Medicare & Medicaid Services (CMS) proposed potentially significant revisions to the federal Sunshine Act rules. Among other changes, CMS suggested eliminating the rule section that explicitly excludes certain continuing medical education (CME) speaker compensation from manufacturers’ transparency reports. The life-sciences industry had pushed hard for this exclusion prior to the … Continue reading
By listserv message, CMS announced that applicable manufacturers and applicable group purchasing organizations (“GPOs”) can start Phase 2 of Open Payments registration and detailed data submission process on June 1. Phase 2 itself has two steps and Phase 2 closes on June 30, 2014: Step 1: Starting June 1 Applicable manufacturers and applicable GPOs must complete system registration and confirm … Continue reading
The CMS has posted new resources to its “Open Payments” website to clarify its recently announced two-stage approach to registration and data submission. These resources include: Step-by-step instructions for completing new user registration with the CMS Enterprise Portal, A sample template to be used for Phase 1 aggregate data submission, and New frequently asked questions (FAQs) on … Continue reading
In a posting to its Open Payments website (through which it communicates about the Sunshine Act), CMS announced that the March 31 data submission deadline (originally set under the statute for March 31, 2013 and delayed by rule to March 31, 2014) would again be delayed to “approximately May 2014.” The Manufacturer registration start date has also … Continue reading