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AGG Food & Drug Newsletter - February 2023

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

New California Law Requires Physicians to Provide Patients with Notice of the Federal Open Payments Program

A new California law – Assembly Bill 1278, which was signed by the Governor on September 29, 2022 – requires physicians to provide patients with notice of the federal Open Payments database. The federal Open Payments program...more

The Times They Are A-Changin’: CMS Solicits Comments to Proposed Changes to the Open Payments Program

Since the April 2013 effective date of the Final Rule implementing the “National Physician Payment Transparency Program: Open Payments” (also known as the federal “Sunshine Law”), CMS has been annually collecting information...more

CMS Expands Open Payments Reporting

The “National Physician Payment Transparency Program: Open Payments” requires certain manufacturers of drugs, devices and certain other products to disclose annually to the Centers for Medicare and Medicaid Services (CMS)...more

U.S. Senate Finance Committee Chairman and Ranking Member Write to HHS-OIG Regarding Physician-Owned Distributorships' Potential...

In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services (HHS) Office of Inspector General...more

Senator McCaskill Introduces Bill to Amend Sunshine Law

In June 2018, Senator Claire McCaskill (D-Mo.) introduced the Patient Advocacy Transparency Act of 2018 (the “Act”), which, if adopted, would amend the Physician Payment Sunshine Act (the “Sunshine Law”). ...more

Summary of 2016 CMS Final Rule for Advance Care Planning

On October 30, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued the 2016 final Medicare payment rules for physicians, hospitals and other providers. The rules include a provision that empowers patients,...more

CMS Proposes to Establish Separate Payment for End of Life Planning Services

On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that updates payment rates and related reimbursement and quality policies for physician services furnished under the Medicare...more

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