Category: Sunshine Act
CMS Issues Sunshine Act FAQs
CMS recently issued an FAQ clarifying one of the most puzzling questions regarding implementation of the Sunshine Act reporting requirements: whether manufacturers must report transfers of value (“TOVs”) to non-physician employees of teaching hospitals. CMS’s answer is that “[n]on-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physician-owned entity are not covered recipients for the purposes of [the Sunshine Act regulations]. Accordingly, payments or other transfers of value made to these non-physician employees generally do not need to be reported.” However, CMS added, the TOV would be reportable if the employer requested that the manufacturer make the TOV to the employee, or if the manufacturer designated that the TOV was made on behalf of the employer. In addition, CMS added that if the manufacturer makes a TOV to a non-physician employee, requiring, instructing or directing that it be passed on … Read More »
French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular … Read More »
Privately Held Medical Device and Drug Companies Face Unique Sunshine Act Challenges
As widely reported, the Centers for Medicare and Medicaid Services (“CMS”) recently issued regulations implementing the Sunshine Act provisions of the Affordable Care Act. These regulations require medical device and pharmaceutical companies to submit annual reports to CMS describing all payments and “transfers of value” to physicians and teaching hospitals. Companies must begin to collect data on August 1, 2013, and the first annual report will be due on March 31, 2014. CMS will post the reports on a public website.
Less discussed is the additional reporting duty imposed on privately held drug and device companies. Privately held companies must also report information about each shareholder/owner who is either a physician or who has a physician as an immediate family member. The new regulation defines “immediate family member” broadly to include spouse, parent, child, sibling, stepparent, stepchild, stepsibiling, grandparent, grandchild, and … Read More »
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 »
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … 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 »