Compliancy & Transparency

KAVO 'S STATEMENT OF COMPLIANCE WITH THE FEDERAL PHYSICIAN SUNSHINE ACT

The Open Payments/Physician Payments Sunshine Act (“Open Payments”) was signed into law as part of the Affordable Care Act in March 2010. Official guidance on this law can be found on the Centers for Medicare and Medicaid Services (“CMS”) Website.  For your convenience, the following was prepared from the official materials published by CMS and does not constitute legal advice.

Section 6002 of the Federal Affordable Care Act includes the establishment of a transparency program, known as the National Physician Payment Transparency Program (commonly referred to as the Sunshine Act but officially referred to as “Open Payments”). Open Payments requires applicable manufacturers to report annually to CMS certain payments and other transfers of value provided to covered recipients.

A covered recipient is defined as a physician or teaching hospital. Physician includes doctors of medicine and osteopathy, dentists, dental surgeons, podiatrists, optometrists and chiropractors, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants and certified midwives with an active state license – whether or not they are currently treating patients. Medical residents, students and pharmacists are not considered covered recipients.

CMS has committed to publishing a list of teaching hospitals annually. The current list of teaching hospitals can be found here.

Beginning August 1, 2013, payments made to covered recipients, both directly and indirectly, must be captured and eventually reported to CMS. Reportable payments or transfers of value include, but are not limited to: consulting fees; speaker fees; honoraria and other compensation; gifts; entertainment; food and drinks; travel; lodging reimbursement; educational materials for physician use; research; clinical trial and grant payments; royalty or license payments; charitable contributions made on behalf of a Covered Recipient; fees paid to Teaching Hospitals; and current or prospective ownership or investment interest; Debt Forgiveness, Long-Term Medical Supply or Device Loans (loans of supplies or devices for a period greater than 90 days, i.e., 91 days or more during a single one year period), Buyout payments to covered recipients with ownership interests in an acquired company, compensation for faculty or speakers at a Medical Education Program.

Applicable manufacturers (engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply having a physical office in or conducting actives in the United States, or in a territory, possession, or commonwealth of the United States or under common ownership and which provides assistance or support to such entity) of covered products (drugs, devices, biologicals, and medical supplies that are reimbursed or reimbursable under Medicare/Medicaid/CHIP and that require FDA approval, licensure, or clearance) are required to report information to CMS.

Dealers and resellers that take title to a covered product are also generally responsible to report transfers of value under Open Payments.

Applicable Manufacturers are required to report to CMS direct and indirect payments or transfers of value to covered recipients by the 90th day following the reporting year. CMS publishes these reports annually on June 30th at its website https://www.cms.gov/openpayments.

Yes, Covered Recipients will be able to review any reportable information before the data is made public, and to dispute any data they believe to be inaccurate. CMS is providing a 45-day review and correction period, during which covered recipients may register and then sign into the CMS secure website and review the data submitted by applicable manufacturers on their behalf and choose to dispute certain payments or other transfers of value. As soon as a dispute is initiated, applicable manufacturers may begin resolving the dispute and correcting the data. Following the end of the review and correction period, applicable manufacturers will have an additional 15 days to correct data for purposes of resolving disputes. Undisputed data will be finalized for publication after the close of the annual 45-day review and correction period. The correction and review period will begin no later than August 1, 2014.

We are tracking all applicable payments and transfers of value to physicians and teaching hospitals. In order to provide a correct representation of our physicians as well as our company, it is imperative that this data be accurate. Therefore, we are working to create an internal system in which covered recipients can communicate directly with our businesses to confirm or dispute any transactions. Additional information will be provided when this system is live.

We encourage all healthcare professionals to familiarize themselves with Open Payments and to register with CMS in order to receive updates regarding the program. The link to register with CMS is https://www.cms.gov/openpayments.

Below are some additional reference materials for your convenience: