The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more
Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more
The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers...more
In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing...more
In This Issue: - Connecticut Supreme Court: HIPAA Does Not Preempt Negligence Claims - CMS Removes Continuing Education Exemption to Physician Payments Sunshine Act - Federal Government and New York...more
Last Friday, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable...more
Sometimes there’s less to life than meets the eye. Take the final rule issued last Friday by CMS on reporting CME (for continuing medical education) payments under the Physician Payments Sunshine Act....more
On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more
As we discussed in Part 1 and Part 2 of this ongoing story, the Centers for Medicare & Medicaid Services (CMS) has received significant criticism related to issues with the Open Payments database and its plans to release the...more
As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more
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...more
On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
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. ...more
Once again the Obama administration has been tripped up in launching a healthcare-related online system. This time the problem concerns the Physician Payments Sunshine Act—the act that is supposed to enable the public to see...more
Congress begins its summer recess this week, but last week legislators were busy holding hearings on management issues regarding HealthCare.gov, introducing legislation to increase payments to primary care doctors under...more
On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more
Teaching hospitals and physicians who speak at continuing medical education (CME) programs should be interested in a July 11, 2014, announcement by the Centers for Medicare & Medicaid Services (CMS). The announcement proposes...more
The Centers for Medicare & Medicaid Services (CMS) announced today that the Open Payments review, dispute and correction process will begin on Monday, July 14, 2014 and continue through September 11, 2014. ...more
It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more
The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more
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...more
CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more
In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more