Tag archives: sunshine act

Stay tuned – CMS plans to consider public comments received on the Sunshine Act

Health Law PulseBy on Posted in Transparency
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

Not just physicians? Bill seeks to expand Sunshine Act to PAs and NPs

Health Law PulseBy on Posted in News from DC, Transparency
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

CMS releases 2014 Sunshine Act data

Health Law PulseBy on Posted in Transparency
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

Government gears up: Sunshine data informs investigations and inquiries

Health Law PulseBy on Posted in News from DC, Transparency
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

OIG releases FY 2015 work plan mid-year update

Photo of Carol Poindexter (US)Photo of Savannah Wiseman (US)By Carol Poindexter (US) and Savannah Wiseman (US) on Posted in Regulatory
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

CMS releases data on nationwide drug prescribing patterns

Health Law PulseBy on Posted in Transparency
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

Broad interpretation of France’s Sunshine Act continues global trend toward transparency

Photo of Savannah Wiseman (US)By Savannah Wiseman (US) on Posted in Transparency
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

Sunshine Act data submission / correction begins today

Health Law PulseBy on Posted in Transparency
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

Top things you should know about the Sunshine Act database

Health Law PulseBy on Posted in Transparency
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

Although CME exclusion no longer available, broader approach may apply for Sunshine Act reports

Health Law PulseBy on Posted in Transparency
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

CMS returns payment records for review and correction

Health Law PulseBy on Posted in Transparency
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

Sunshine around the world

Photo of Mike Knapper (UK)Photo of Huw Evans (UK)By Mike Knapper (UK) and Huw Evans (UK) on Posted in International, Transparency
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

Sunshine Act data now available

Health Law PulseBy on Posted in Transparency
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

Sunshine data 33 percent unpublishable, penalties next?

Health Law PulseBy on Posted in Transparency
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

Changes proposed to Sunshine Act reporting would remove CME exclusion, may broaden availability of “indirect-payments” exclusion

Health Law PulseBy on Posted in Transparency
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

Phase 2 reporting opens June 1

Health Law PulseBy on Posted in Transparency
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

CMS offers new resources and guidance on two-phase approach to Sunshine Act reporting

Health Law PulseBy on Posted in Transparency
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

CMS delays data submission at least 30 days

Health Law PulseBy on Posted in Regulatory
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
LexBlog