Tag: proposed rule

Proposed Rule Issued by CMS re: Expansion of Open Payments Reporting

The Centers for Medicare & Medicaid Services (CMS) issued this week a proposed rule regarding the expansion of Open Payments reporting requirements (Proposed Rule). As we discussed here, the 2018 SUPPORT Act expanded the definition of “covered recipients” to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse […]

White House Withdraws Rebate Rule

Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for pharmaceutical manufacturer rebates to Medicare Part D plans, Medicaid MCOs and the PBMs with which […]

HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts

On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to eliminate rebates paid by pharmaceutical manufacturers to plan sponsors or their pharmacy benefit managers (“PBMs”) […]

No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”).  Currently, although manufacturers often voluntarily make their product PIs available electronically, they are […]

OIG Releases Proposed Rule re: Beneficiary Inducements and Gainsharing Revisions

The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing.  The 94-page proposed rule is expected to be published tomorrow in the […]

OIG Issues Proposed Rule Related to Health Care Exclusion Authority

The Health and Human Services Office of Inspector General (OIG) issued a proposed rule related to its authority to exclude individuals and health care entities from participation in federal health care programs, such as Medicare and Medicaid.  The proposed rule codifies changes made by the Affordable Care Act of 2010 (ACA), which […]