Tagged: OIG

OIG’s Latest Congressional Report Sees Continued Emphasis on Fraud and Abuse Enforcement

Carson Lamb

In the final quarter of calendar year 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) released its Semiannual Report to Congress (the “Report”).  The Report covers the six-month period from April 2019 through September 2019 and details for Congress the OIG’s activities during that time and how the office uses...

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

Laura B. Morgan

In 2018, the Department of Health and Human Services (the “Department”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the health care system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Numerous federal agencies have requested comments and information from the public and...

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

Laura B. Morgan

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”).  CMS also published its annual update to CPT/HCPCS codes used to identify...

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process

Laura B. Morgan

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Laura B. Morgan

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...

CMS “Actively Working” on Stark Law Reforms to be Issued Later this Year; “Regulatory Sprint to Coordinated Care” Continues

Laura B. Morgan

The Centers for Medicare & Medicaid Services (CMS) is “actively working” on updates to regulations under the federal physician self-referral law (or “Stark Law”), according to CMS Administrator Seema Verma during a March 4, 2019 speech. Verma stated that the updated regulations will be issued later this year, and “will represent the most significant changes...

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Benjamin Fee

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...

OIG Seeks Public Input on Anti-Kickback Statute and Beneficiary Inducements CMP as part of the “Regulatory Sprint to Coordinated Care”

Laura B. Morgan

The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements.  On August 27, 2018, the OIG published a Request for Information (RFI) seeking input...

OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement

Nicole Burgmeier

On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction...