Tagged: OIG

Is Your Compliance Program More than a Paper Program? DOJ Issues Revised Guidance for Evaluating Corporate Compliance Programs

Laura B. Morgan

On June 1, 2020, the Department of Justice (“DOJ”) issued an updated version of its “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), available here. The DOJ Guidance is an update to guidance first issued by the DOJ in February 2017 (which we described in our prior blog post), and was last updated by the...

OIG Initiatives to Ease Provider Burdens Related to COVID-19

Laura B. Morgan

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has taken numerous steps to minimize regulatory burdens for providers who need to make their primary focus delivering patient care during the COVID-19 national emergency. These steps, along with recent steps taken by other agencies to provide temporary regulatory flexibility, provide further...

Medicare Telehealth Payment Expanded to Help Address the COVID-19 Public Health Emergency

Ross C. D'Emanuele

On March 17, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) each issued policy statements which expand access to telehealth services for Medicare beneficiaries and permit physicians and other practitioners to reduce or waive beneficiary cost-sharing obligations for Medicare telehealth...

First EKRA Enforcement Announced

Charis Zimmick

The first publicly disclosed prosecution under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month, a little over a year after EKRA became law. As we described in a previous blog post, EKRA criminalizes certain health care payment arrangements related to referrals, regardless of payor. In the recent EKRA prosecution, an office manager of...

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...