Category: Healthcare

No Surprise! – Drug Pricing Legislation Picking up Steam

Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress. On Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the bipartisan Lower Health Care Costs Act (LHCCA) discussion draft. Today, the Committee released a new draft based on […]

Medicare for All unveiled in House. Some things old, some things new, but much left to do

Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.  M4A differs from single-payer plans released by Senator Bernie Sanders (I-VT) and various Washington think tanks. One of the most significant differences […]

340B Drug Program Price Ceiling and Penalties Moved Up To Start January 1st

On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019, rather than July 1, 2019 as previously announced significant changes to the 340B program including a ceiling price on how much drug manufactures can charge hospitals who […]

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 […]

***Updated** HHS Releases Plan to Require Drug Makers to list prices on TV ads

***Update- Final rule released*** Yesterday HHS released the final rule which takes effect in 60 days.  The final rule made some technical changes and one notable change, that state law-based claims that depend “in whole or in part on any pricing statement required by this rule” are preempted.  Yesterday, the Department […]

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]

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) […]