Category: Medicare

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]

CMS Releases Guidance Allowing Step Therapy for Part B Drugs

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.

CMS Requests Information Regarding The Stark Law’s Potential Barriers to Coordinated Care

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a Request for Information (“RFI”) in the Federal Register regarding section 1877 of the Social Security Act, also known as the “physician self-referral law” or the “Stark Law”. The Stark Law is a strict liability statute that: […]

OIG Advisory Opinion Permits Limited Provision of Free Telemedicine Hardware and Services

On May 31, 2018, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-03 regarding an arrangement in which a not-for-profit Federally qualified health center look-alike (Provider) would provide, at no charge, certain information technology-related equipment and services to a County Department of Health health clinic (County Clinic) for […]

**UPDATED*** Administration Releases Long-Awaited Drug Pricing Reform Plan

***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 […]

OIG Advisory Opinion Approves Ostomy Supply Distributor to Provide Free Product Samples

On Monday, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-02 regarding an arrangement in which the Requestor who distributes and sells, but does not manufacture, certain ostomy products (Products) provides a limited number of free Product samples to patients and contracts with a third party (Contractor) to […]