Tag: payment
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
DOJ and SEC Issue Long-Awaited Resource Guide to the Foreign Corrupt Practices Act
On November 14, 2012, the Department of Justice and the Securities and Exchange Commission published their much anticipated Resource Guide to the U.S. Foreign Corrupt Practices Act.1 There is little new in the Guide to clarify the circumstances under which the government will charge companies or individuals with FCPA violations. Instead, the Guide reiterates previous government pronouncements that the FCPA should be construed broadly, and cites its own charging decisions as “authority” for what the statute proscribes. Basically, the Guide is a comprehensive compilation of “authority” formerly found only in various Government press releases, settlement agreements and guilty pleas. Thus, the guidance is somewhat of a disappointment for the experienced FCPA practitioner and for companies that already have robust compliance programs. In a few areas – notably in its discussion of gifts, travel and entertainment – the Guide does offer … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »