The Sunshine Act exposes the physicians and sponsors to new clinical trial reporting requirements and detail non-compliance to which would lead to hefty fines. Part of the Patient Protection and Affordable Care Act (aka, “Obamacare”), it requires pharmaceutical and medical device manufacturers to publicly report many types of payments made to physicians, which will be public. The PPSA also imposes penalties for failure to comply with these reporting requirements. For … Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (Applicable Manufacturers) to report annually to the … Under the Sunshine Law, “physicians” include doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors. blog post from August 2013: Learn if the reporting requirements apply to your company. 2. What does Sunshine Act reporting look like? The result is that companies need to accurately report on how much they spent providing gifts or items of value to any physician (with some exceptions) or to any teaching hospital. In light of the significant complexity the rule presen The Sunshine Act requires that detailed information about payments and other “transfers of value” worth over $10 from manufacturers of drugs, medical devices and biologics to physicians and teaching hospitals be made available to the public. Applicable manufacturers will now be required to report payments and other transfers of value to physician assistants and advance practice nurses, in addition to physicians and teaching hospitals. U.S. Federal Sample Report (drug only) who is licensed in any state in the U.S., whether or not they are practicing. The Sunshine Act requires applicable manufacturers to report payments or other transfers of value to physicians or teaching hospitals, as well as ownership and investment interests held in the company … § 1320a–7h(a). Key Updates on the Sunshine Act Reporting Requirements You Need to Know [WEBINAR] Tuesday, December 8, 2020. How It Works: Each webinar CD has a series of modules. The Sunshine Law requires that payments and transfers of value made by life science manufacturers to “Physicians” and “Teaching Hospitals” be reported. Exhibit 1 - The Sunshine Act Reporting Process. The new FDIA provisions require nongovernmental entities or persons (NGEPs) and insured depository institutions and affiliates that are parties to certain written agreements made in fulfillment of the Community Reinvestment Act of 1977 (CRA) to make the agreements available and to file annual reports about the agreements. Apply to Account Manager, Territory Manager, Export Manager and more! This is a law passed in 2010 meant to increase transparency regarding gifts or payments to particular kinds of medical professionals. the National Physician Payment Transparency Program (Open Payments), is a section of the Patient Protection and Affordable Care Act of 2010. Background. General Requirements of the Sunshine Act • Pharmaceutical and Device Manufacturers must report payments or other transfers of value made to or on behalf of physicians (or their immediate family members) and teaching hospitals to DHHS annually (hereinafter referred to … Step 1: Complete an e-verification process by logging into the CMS Enterprise Portal (EIDM). Under the Act, payments or other transfers of value by an applicable manufacturer to a “covered recipient” must be reported. Your company is an “applicable manufacturer” if it is both: On August 1, 2013, the first reporting period under the Physician Payment Sunshine Act began. § 1302 et seq. The Sunshine Act exposes the physicians and manufacturers to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. Covered recipients are teaching hospitals and physicians, except bona fide employees of the applicable manufacturer. 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