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CMS Announces Enforcement Discretion with Sunshine Act Reporting Deadline Ahead

As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or...more

With Sunshine Act Submission Deadline Looming, CMS Announces Enforcement Discretion

The Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25 saying that it planned in some cases to exercise enforcement discretion with respect to late or incomplete data...more

CMS Updates Open Payment Regulations, with a Short Window for Industry Comments

Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and...more

Proposed Physician Fee Schedule Rule Tweaks, Expands Open Payments Program

The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more

House Committee Approves Drug Price Transparency Legislation/Drug Sample Reporting Requirement Under Sunshine Act

Clearing the way for consideration by the US House of Representatives, the Ways and Means Committee has unanimously approved bipartisan legislation aimed at increasing drug price transparency by manufacturers and pharmacy...more

Senate Bill Would Require Disclosure of Payments to Patient Advocacy Organizations Under Sunshine Act

Recently introduced legislation would expand the US Physician Payments Sunshine Act to include reporting of financial ties between pharmaceutical and medical device manufacturers and patient advocacy organizations. Any such...more

Sunshine Act Update: CMS Streamlines Reporting for CME-Related Payments in 2016

CMS issues a Final Rule that removes the exclusion for reporting of continuing education payments to certain accredited organizations, while also clarifying previously existing parameters that may preclude reporting of these...more

Open for Business: CMS Open Payments System Begins in Phases

With the Open Payments System rollout, came the phased approach for data submission, requiring aggregate data in Phase 1 and detailed data reporting in Phase 2. ...more

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