On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).  MiMedx executives claim that such reporting is unnecessary because the company’s products are tissues, which are not explicitly included in the regulatory definition of “covered drug, device, biological, or medical supply” to which the Open Payments Program apply (42 C.F.R. 403.902). As a result of falling outside this definition, MiMedx argues that it is not an “applicable manufacturer” required to disclose payments to physicians and teaching hospitals.  MiMedx’s product-specific reasoning aside, the company’s argument brings up an interesting point about the evolution of FDA-regulated products and the enforcement of the Open Payments Program requirements: Does the PPSA, and its corresponding regulations, require manufacturers of tissue-based therapies to disclose payment information? Continue Reading Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

Written by: Kate Stewart

On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was previously excluded from reporting in the Open Payments system due to data errors.  Applicable manufacturers and GPOs will have until the end of the 2014 data submission and attestation period (expected to be March 31, 2015) to submit the corrected reports for the 2013 reporting year. 

Applicable manufacturers and GPOs were initially required to report payments made to physicians and teaching hospitals and ownership interests held by physicians for the period running from August 1, 2013, to December 31, 2013, by June 30, 2014.  As previously reported, after the initial reporting of 2013 data, CMS temporarily shut down the Open Payments system to address problems with data submissions.  After the shutdown, approximately one-third of the submitted records were flagged as having errors related to the identity of the recipient of the payment.  These payments were not included in the data that was publicly released on September 30, 2014. 

Applicable manufacturers and GPOs can now download a Removed Records Report from the Open Payments system showing the records that were removed.  A guide for correcting records is also available.  CMS will host a webinar on November 13, 2014 at 1:00pm EST to address the re-submission of data.

Written by: Thomas S. Crane and Kimberly J. Gold

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).

Mandated by the Affordable Care Act, the Sunshine Act creates a regulatory scheme requiring drug and device manufacturers and group purchasing organizations (GPOs) to report a variety of information about payments and other transfers of value to physicians and academic medical centers.  The first data reporting period was for August 2013 through December 2013, and this data is now available on the Open Payments website.

Unlike last year’s launch of the federal health insurance exchange website, the Open Payments website appears to be working smoothly.  CMS reported that the payment information includes over 4.4 million payments valued at nearly $3.5 billion.  More than 26,000 physicians and 400 teaching hospitals registered through the Open Payments data system.

Continue Reading A Brave New World of Transparency Reporting: CMS Launches Open Payments Website

Written by Kate Stewart

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and teaching hospitals. On Friday, August 15, CMS notified users and the Open Payments systems had re-opened.

CMS noted that the errors that led to the temporary shutdown were related to data errors that linked physicians with the same first and last name and intermingled their data in the reporting system. Though the initial CMS email announcing the re-opening of the Open Payments system did not address the volume of records flagged as incorrect during the shutdown, a CMS spokesperson noted that one-third of records submitted to Open Payments were being returned to manufacturers due to errors. Payments flagged as incorrect by CMS have been removed from the current data set and will not be published in this cycle of payment data.

Despite the temporary shutdown, CMS still plans to launch the Open Payments data publicly on September 30, 2014. Physicians and teaching hospitals now have until September 8, 2014 to review and dispute data reported about them. The correction period for disputed data, originally slated to end on September 11, 2014, will now run until September 23, 2014.

Written by:  Brian P. Dunphy

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act. The Open Payments system has encountered data issues and has been the subject of growing criticism from physician organizations and industry groups. The Centers for Medicare & Medicaid Services (“CMS”) recently announced that the Open Payments website went offline “temporarily to investigate a reported issue” involving incorrect data. The shutdown raises questions about CMS’s ability to make Sunshine Act data publicly available by its September 30, 2014 deadline and the accuracy of the reported data.

CMS has implemented a multi-step process for data reporting and validation under the Sunshine Act. During the first step, completed around June 30, 2014, Manufacturers covered by the Sunshine Act reported to CMS payments and transfers of value to physicians and teaching hospitals. Now that Manufacturers have submitted payment data, physicians and teaching hospitals (the payment recipients) are in the midst of a 45-day period during which they may register through Open Payments and review and dispute the data that Manufacturers have reported about them. Lastly, once the review and dispute process has ended, CMS will publicly release payment data by September 30, 2014.

Continue Reading CMS Temporarily Closes the Open Payments System

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for Medicare and Medicaid Services (“CMS”) has issued additional guidance on Phase 2 reports. As is well known, the Sunshine Act (the “Act”) requires Applicable Manufacturers and GPOs to report certain financial relationships with physicians and teaching hospitals. The new guidance includes both technical guidance for preparing and uploading data submissions and an updated User Guide.

Continue Reading As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

Written by: Brian Dunphy and Kate Stewart

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the Physician Payments Sunshine Act (the “Act”).  The final rule implementing the Act (“Final Rule”) set a March 31, 2014 deadline for all data (covering August 2013 through December 2013) to be submitted to CMS through its Open Payments Program.  In addition, CMS guidance provided in a previous webinar had indicated that manufacturers and GPOs covered by the Act would be able to register in “early 2014” and that registration would remain open for 90 days.  The guidance, however, provided through an email announcement and on the Open Payments website, announced a delayed start of registration and explained that registration and reporting will now take place in two phases (for the first Sunshine Act reporting period only).

Continue Reading More Open Questions About Open Payments Under the Sunshine Act

Written by Kate Stewart

Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers and GPOs with compliance, to educate physicians and teaching hospitals about the reporting process, and to resolve ambiguities in the Act and the Final Rule.   Continue Reading CMS Continues to Issue Guidance on Sunshine Act Reporting

Written by Karen Lovitch and Kate Stewart

In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to address the many questions being asked by affected parties.  Adiscussed in previous posts, applicable manufactures (“Manufacturers”) and group purchasing organizations (“GPOs”) must begin collecting data on payments and other transfers of value given to physicians and teaching hospitals as of August 1, 2013, and initial reports are due to CMS by March 31, 2014.  

To educate affected parties about the Open Payments Program, CMS is holding a series of National Provider Calls.  The first call took place last week.  Those who missed the call can access the slide presentation on CMS’ website, and CMS plans to post an audio recording and transcript at a later date.  Continue Reading CMS Conducts First Call on Physician Payments Sunshine Act Implementation

Written by Karen Lovitch and Kate Stewart

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources, including Fact Sheets and Frequently Asked Questions, for pharmaceutical and medical device manufacturers (“applicable manufacturers”), group purchasing organizations (“GPOs”), physicians, and teaching hospitals.   CMS intends to communicate with individuals and entities affected by the Sunshine Act through this website and thus will post additional tools and resources as appropriate and will use the website a way to announce any webinars, calls, and meetings.  Continue Reading CMS Officially Launches National Physician Payment Transparency Program Website