President Trump has just signed into law HR 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The bipartisan legislation includes almost 200 provisions intended to strengthen opioid prevention and treatment efforts and bolster law enforcement tools. Among many other things, the new law: Seeks to encourage … Continue Reading
CMS has announced inflation-adjusted de minimis reporting thresholds for 2018 under the Open Payments/Physician Payments Sunshine Act program. Specifically, payments or transfers of value of less than $10.49 do not need to be reported in 2018, except when the total annual value of payments or other transfers of value to a covered recipient exceeds $104.90. … Continue Reading
CMS has just corrected an error in a 2016 rulemaking that inadvertently called for a 10-fold increase in certain “Sunshine Act” civil monetary penalties (CMPs). Under section 1128G of the Social Security Act, applicable manufacturers must report annually to CMS any payments or other transfers of value to covered recipients. In addition, the statute requires … Continue Reading
On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting 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. … Continue Reading
For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors (“PODs”). From the Department of Health and Human Services Office of Inspector General’s (“OIG”) issuance of the March 2013 OIG Special Fraud Alert (“Special Fraud Alert”), to the Reliance Medical Systems challenge to the Fraud Alert, to the subsequent failure … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that self-identified as physician-owned and previously reported having purchased spinal devices from PODs. The OIG attempted to determine whether physicians had an ownership interest … Continue Reading
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 through a variety of reforms addressing drug and device development … Continue Reading
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
On January 15, 2015, CMS is hosting an Open Payments Question & Answer Session, at which the CMS “Open Payments team” will be available to respond to questions about the data refresh and the upcoming 2014 Open Payments program year. CMS intends to conduct these sessions monthly in the future.… Continue Reading
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
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 pharmaceutical and medical device manufacturers and group purchasing organizations to submit to CMS certain information on … Continue Reading
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
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 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
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
On July 11, 2014, CMS published its proposed rule to update the Medicare physician fee schedule for CY 2015. The proposed rule reflects enactment of the Protecting Access to Medicare Act (PAMA) of 2014, which provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March … Continue Reading
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
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 Open Payments program. These proposed changes come just three days after the inaugural deadline … Continue Reading
On June 12, 2014, CMS is hosting a National Provider Call to explain Physician Payment Sunshine Act “Open Payments Program” registration requirements and the upcoming review and dispute process.… Continue Reading
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
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
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
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
