Senator Maggie Hassan (D-NH) and Senate Minority Whip Dick Durbin (D-IL) have introduced legislation intended to “hold predatory institutions, including for-profit schools, accountable when they engage in unfair, deceptive...more
This week has subjected the college admissions process – already the subject of considerable debate – to unprecedented scrutiny. The nationwide indictments unsealed by the US Department of Justice (DOJ) in the past few days...more
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...more
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...more
The many-headed Obama-era Borrower Defense to Repayment Rule is back, thanks to a September 17 federal court order that overturned Secretary DeVos’ action suspending implementation of the existing rule, followed by the...more
Yesterday, the Department of Health and Human Services (“HHS”) through the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would require “direct-to-consumer (DTC) television advertisements of...more
Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary’s Innovation and Investment Summit (DSIIS). DSIIS follows a June 2018 request for information to...more
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...more
The President and Health and Human Services (HHS) Secretary Alex Azar unveiled a 44-page Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, designed to bring “soaring drug prices back down to earth.” The President...more
Tomorrow at 2 p.m., EST, the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.” While details of the speech have been closely held, it is anticipated that it...more
Digital platforms that sell political ads are closely following the Federal Election Commission's review of two alternative sets of rules, both of which would impose new disclosure requirements on certain digital political...more
Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are...more
On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies. By clarifying what is –...more
The Higher Education Act (HEA), the foundation law for the financing of American higher education, was enacted in 1965, when telephones still had dials and computers filled large rooms. It last was reauthorized in 2008, when...more
Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration,...more
Last week, the Administration took two actions aimed at rattling the foundations of the Affordable Care Act (ACA). The President signed an Executive Order (EO) directing federal agencies to relax restrictions on insurance...more
Anyone who watches television or listens to radio during an election cycle is bombarded with political advertisements from candidates, political parties and issue groups. While some commentators have lamented the rise of...more
Earlier today, the Centers for Medicaid Services (CMS) released a notice withdrawing the “Medicare Program; Part B Drug Payment Model”, also known as the “Part B Demo.” As we discussed in a previous post, in December 2016,...more
Update: As a reminder, the Department of Education (ED) is seeking public comments to identify regulations that are “unduly costly or unnecessarily burdensome” and may be candidates for repeal or revision. We encourage you to...more
Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more
In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization. The bill, titled the “FDA Reauthorization Act of 2017,”...more
Yesterday, the Department of Education held the first of two public hearings to hear comments on the agenda for the upcoming negotiated rulemaking, currently slated to include borrower defense to repayment and gainful...more
The Department of Education’s (ED) announcement that it plans to engage in a new negotiated rulemaking to revise the Gainful Employment (GE) Rule leaves unanswered critical questions regarding the implementation of certain GE...more
The Department of Education announced today that it will delay, with limited exceptions, the entire set of Borrower Defense to Repayment regulations (BDTR) scheduled to take effect July 1 until further notice, as well as...more
While there are indications that Washington has lessened its antipathy towards for-profit institutions, states continue to go in their own directions. This post focuses on the California Assembly’s recommendation to eliminate...more