Tag Archives: Sunshine Act

21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

This post was written by Katie Pawlitz and Jeremy Alexander. As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States … Continue Reading

House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability … Continue Reading

CMS Publishes Final 2015 Medicare Physician Fee Schedule Rule for 2015

On November 12, 2014, CMS published its final rule to update the Medicare physician fee schedule (MPFS) for CY 2015. Highlights of the sweeping rule include the following: The Protecting Access to Medicare Act (PAMA) of 2014 provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 … Continue Reading

CMS Adopts Changes to Open Payments/Physician Payment Sunshine Act Regulations

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy. As part of the final 2015 Medicare physician fee schedule rule, CMS is adopting – with certain refinements – its proposed changes to the regulations implementing the Physician Payment Sunshine Act. By way of background, the Sunshine Act requires … Continue Reading

Update on Sunshine Act “Open Payments” Public Data Review and Data Correction Deadline

CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information.  The tool allows the public to search identified … Continue Reading

CMS Launches “Open Payments” Public Database; Usability Concerns Remain

Despite a series of technical problems and data disparities leading up to the launch, CMS met its schedule to release the first round of “Open Payments” data on September 30, 2014. Note that initial use of the database of financial payments made by drug and device manufacturers and group purchasing organization to physicians and teaching hospitals … Continue Reading

CMS Revises Sunshine Act “Open Payments” System Review/Dispute Deadlines Amid Concerns about Data Accuracy

CMS has reopened the Open Payments system after it was taken offline temporarily to “resolve a data integrity issue.” According to a CMS press release, applicable manufacturers and group purchasing organizations (GPOs) had submitted intermingled data (e.g., wrong state license number or national provider identifier) for doctors with the same last and first names, which … Continue Reading

Sunshine Act “Open Payments” System Off to Rocky Start as Data Discrepancies Force System Off-Line

CMS has taken the Open Payments system offline temporarily “to investigate a reported issue,” according to a recent CMS email announcement.  As a result, physicians, teaching hospitals, and authorized representatives may not register and review data related to payments by applicable manufacturers and applicable group purchasing organizations at this time. The shut-down of the system reportedly … Continue Reading

Sunshine Act Open Payments System Review/Dispute Process Underway

CMS has made a series of announcements related to the Sunshine Act Open Payments system, including information about the Open Payments review, dispute and correction process that runs from July 14 through August 27, 2014. This period allows physicians and teaching hospitals to review and initiate any disputes they may have regarding the data reported about … Continue Reading

CMS Proposes Changes to Sunshine Act “Open Payments” Regulations in 2015 Medicare Physician Fee Schedule Rule

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, and Nancy E. Bonifant. Today the Centers for Medicare & Medicaid Services (CMS) issued an advance copy of the CY 2015 Medicare Physician Fee Schedule (PFS) proposed rule, which includes certain changes to the regulations implementing the Physician Payment Sunshine Act, also known as the … Continue Reading

CMS Invites Comments on Sunshine Act “Open Payments” Dispute Resolution/Corrections Process

CMS is inviting comments on the Physician Payment Sunshine Act “Open Payments Program” dispute resolution and corrections process. As previously reported, the Physician Payment Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This … Continue Reading

Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies - with potential False Claims Act (FCA) implications. Specifically, last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act. In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly-available data are intended to provide more transparency for patients, to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies, patients will certainly not be the only group interested in this public information. It is likely that the Department of Health and Human Services Office of the Inspector General, Department of Justice, and relators' attorneys will utilize these data to initiate investigations and support complaints under the federal FCA.… Continue Reading

CMS Outlines 2013 “Sunshine Act” Open Payments Program Registration/Data Submission Process

This post was written by Katie C. Pawlitz. On February 7, 2014, CMS announced a two-phase registration and data submission process for the 2013 Open Payments Program, the reporting mechanism for the Physician Payment Sunshine Act. Under Phase I, which begins February 18, 2014 and runs through March 31, 2014, applicable manufacturers and applicable group purchasing … Continue Reading

CMS Announces Inflation Update to “Sunshine Act” Reporting Thresholds for 2014

Under the “Sunshine Act” provisions of the Affordable Care Act, certain manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid and CHIP must report annually to the Department of Health and Human Services (HHS) certain payments or transfers of value they have made to physicians and teaching hospitals. CMS has announced that … Continue Reading

OIG Highlights Volume of Spinal Surgeries Tied to Physician-Owned Distributors (PODs)

A recent OIG report links the growing presence of physician-owned distributorships, or PODs, to increased spinal surgery volumes and potentially increased Medicare costs. The OIG notes a “substantial presence” of PODs in the spinal device market, with PODs supplying spinal devices for 19% of the spinal fusion surgeries billed to Medicare in FY 2011. According … Continue Reading

CMS Sunshine Act Update: Covered Teaching Hospitals Listing, Industry Efforts, CMS Provider Call

CMS has released a list of teaching hospital “covered recipients” to which payments and other transfers of value must be reported by applicable drug and device manufacturers under the ACA Physician Payment Sunshine Act Final Rule, as discussed in a posting on our Life Sciences Legal Update blog. The posting also discusses industry efforts to … Continue Reading

CMS Physician Payment “Sunshine” Final Rule — Overview and Analysis

This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz and Nancy E. Bonifant. The Centers for Medicare & Medicaid Services (CMS) has published the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA).  The Sunshine provisions – intended to provide increased transparency regarding the scope and … Continue Reading

CMS Releases Physician Payments Sunshine Act Final Rule

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, and Nancy E. Bonifant. The Centers for Medicare & Medicaid Services (CMS) released late today its final rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the "Physician Payments Sunshine Act." Among other things, the … Continue Reading

Sunshine Act Final Rule Enters Last Stage of Clearance

On November 27, 2012, CMS sent to the White House Office of Management and Budget for final clearance its long-awaited final rule implementing the ACA’s “Physician Payment Sunshine Act” provisions. Under the ACA, applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP will be required to report annually to … Continue Reading

Massachusetts Issues Final Drug/Device “Sunshine” Rules

On November 21, 2012, the Massachusetts Public Health Council finalized amendments to the State’s Marketing Code of Conduct, which restricts certain payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners and imposes other disclosure requirements regarding such payments. The rules, which are effective December 7, 2012, are summarized on the Reed Smith’s … Continue Reading
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