Category: OIG Guidance

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

Laura B. Morgan

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

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...

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)...

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...

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...

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program Beneficiaries

Nicole Burgmeier

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes discounts on certain prescriptions and clinical services offered by the retail chains’ pharmacies and in-store clinics.  Presently, the pharmacy chain’s...

How Effective Is Your Compliance Program? New OIG and DOJ Guidance for Measuring the Effectiveness of Your Corporate Compliance Program

Alissa Smith

Compliance programs are an important tool for health care providers.  Compliance programs help to prevent fraud, waste and abuse, create a mechanism for catching problems early, and effective compliance programs can also provide the basis for a penalty reduction under the US Sentencing Guidelines if an entity is ever faced with sentencing for a criminal...

OIG Announces Drug Pricing and Reimbursement Web Portfolio

Nicole Burgmeier

On February 17, 2017 the Office of the Inspector General (OIG) posted a Drug Pricing and Reimbursement Web portfolio on its website that, according to the OIG announcement, “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.” The...