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Blog: White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

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

Blog: With Congress Stuck, Administration Starts Process Of Unwinding ACA

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

Alert: Who Paid for that Ad? US Considers Internet Disclosure Rules

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

Blog: CMS Withdraws Part B Demo Rule…for good

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

Blog: Department Seeks Public Comment on Regulations to Repeal

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

Blog: Off-Label Use Gets Congressional Hearing

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

Blog: User Fee Reauthorization Picks Up Steam

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

Blog: Department Holds Hearings and Comment Period on Neg Reg Agenda

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

Blog: Department of Education’s Announcement Leaves Unanswered Questions Regarding Coming Gainful Employment Rule Deadline

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

Blog: Department of Education Delays Borrower Defense Rules and Proposes Reset on Gainful Employment

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

Blog: California Assembly Recommends Eliminating For-Profit Institutions from Cal Grant Program

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

Blog: House Passes AHCA; Senate Says “Not So Fast”

Last week, the House of Representatives passed the American Health Care Act (AHCA) by a razor-thin margin of 217-213. No Democrats supported the bill and 20 Republicans voted against it. Recall in March, the House was forced...more

Blog: User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s...more

4/27/2017  /  Biosimilars , FDA , HELP , Prescription Drugs

Blog: Administration Releases “Skinny” Budget; Education Feels the Pinch

On March 16, 2017, the Administration released its Budget Blueprint for 2018. Overall, the Blueprint upholds many of the campaign promises the President made, increasing military spending by significantly cutting funds from...more

Blog: CBO Releases AHCA Budget Score; As Costs Become Clearer, Road to Passage Gets Rockier

On March 13, 2017, the Congressional Budget Office (CBO) released the budget “score” or cost, for the American Health Care Act (AHCA). The headline from the analysis is that the AHCA would cause 14 million people to lose...more

Blog: Important New Gainful Employment Guidance Released

The Department released Gainful Employment Electronic Announcement #105 which gives institutions until July 1, 2017 to “(1) submit an alternative earnings appeal to the GE Debt-to-Earnings rates that were released by the...more

Blog: Off to the Races: First ACA Repeal and Replace Legislation Released

Following through on Republican campaign promises two key Congressional committees released legislation yesterday that further the process of repealing and replacing the Affordable Care Act. After more than 60 attempts to...more

Blog: Price Confirmed For HHS Secretary, Other Key Agency And Department Positions Next To Be Filled

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services. The vote was 52-47 with no Democrats voting in favor. With repeated...more

2/13/2017  /  Affordable Care Act , CMS , FDA , HHS

Alert: DeVos One Step Closer to Department of Education, But Questions Remain

Today the Senate Health, Education, Labor and Pensions (HELP) Committee voted along party lines to forward the nomination of Betsy DeVos to the full Senate. The vote was 12-11 in favor of moving the nomination. Republicans...more

Alert: White House Issues Regulatory Freeze with Minimal Impact on Education Rules

On President Trump’s first day in office, the White House ordered a regulatory freeze to allow the incoming administration to review any new or pending regulations. Federal agencies are required to take several steps to allow...more

Blog: Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from...more

Blog: 21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act,...more

Alert: Presidential Transitions: The Congressional Review Act

This alert is the second in a series on what to expect during the transition between administrations with respect to education policy. Lately, there have been many questions as to whether Congress might employ the...more

Alert: Presidential Transitions: A Primer on Rulemakings

A smooth transition from the outgoing to incoming administration is a hallmark of democracy and something both parties strive to achieve. Among the myriad issues that must be addressed, one of the more important ones for both...more

Alert: Internet Attacks Using IoT Devices Spur Government Calls for Improved Cybersecurity

The recent massive distributed denial of service (DDoS) attack that caused major internet outages was led by an army of security cameras, digital video recorders, and other Internet of Things ("IoT") devices that had been...more

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