***Update- Final rule released*** Yesterday HHS released the final rule which takes effect in 60 days. The final rule made some technical changes and one notable change, that state law-based claims that depend “in whole or in part on any pricing statement required by this rule” are preempted. Yesterday, the Department […]
Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary’s Innovation and Investment Summit (DSIIS). DSIIS follows a June 2018 request for information to “develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing […]
OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’
The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]
The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.” The OIG reviewed data from calendar year 2015 available as of June 2016. The OIG’s key takeaway […]
Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing “step therapy” for Medicare Part B drugs. Recall, the concept of changing the way Medicare pays for Part B drugs was first discussed in the Administration’s May 2018 Blueprint.
The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]
***5/14/2018 Update*** This morning, HHS Secretary Azar gave a speech offering additional details on the Blueprint. Included in his remarks are plans to publicly identify companies suspected of “using public health rules to pad their profits”; send letters to all Medicare Part D plan sponsors indicating gag clauses in pharmacy contracts are unacceptable […]