People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more
On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act. The...more
“Applicable Manufacturers” - Common Ownership Considered to be Ownership by the Same Individuals or Entities of 5 Percent or More in Two Entities - In the Final Rule, CMS defines “applicable manufacturer” as an...more
Reports on Physician Ownership and Investment Interests The Sunshine Act requires applicable manufacturers, as well as applicable GPOs, to report to the Secretary, in electronic form, certain information concerning...more
Report Submission and Review Pre-Submission Review is Not Required Applicable manufacturers may voluntarily provide covered recipients the opportunity to review the data prior to submission to CMS, but doing so is not...more
“Payments or Other Transfers of Value” Payments or Other Transfer of Value Must Have a Discernible Economic Value.In the Final Rule, CMS interprets value as the discernible economic value on the open market in the United...more
Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more
Late afternoon on Friday February 1, 2013, the Centers for Medicare and Medicaid Services ("CMS") published the final rule regarding Transparency Reports and Reporting of Physician Ownership or Investment Interests ("Final...more
“Covered Recipients” - Physicians - The Final Rule retains the proposed definition of “physician” as meaning doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors, who are...more
On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more
On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more
Several agency actions on the Affordable Care Act out of HHS and Treasury last week include proposed regulations detailing exemptions from the shared responsibility tax, such as an exemption for those who would qualify for...more
This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more
The Supreme Court’s decision upholding most of the Affordable Care Act increased compliance responsibilities for healthcare companies. The ACA amended the False Claims Act (FCA), which was amended in 2009 in the Fraud...more
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