Category: Health Reform

The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB Act) by a vote of 240 to 185, split mostly along party lines. If passed by the U.S. Senate and signed by President Trump, the SCRUB Act would […]

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, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for […]

Final Medicare 60-Day Overpayment Rule Provides Reasonable Framework for Providers

Published today in the Federal Register was a long-awaited Final Rule implementing a requirement from the 2010 Affordable Care Act requiring Medicare Part A and B providers and suppliers to report and return overpayments to Medicare by the later of 60 days after the date an overpayment was identified, or the due date […]

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we […]

Final MDRP AMP Rule is Out! Will be Effective on April Fools Day 2016. (No joke.)

If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)!  The publication of this Final AMP Rule follows the 2012 publication of […]

Senate opts for “Step by Step” approach for innovation legislation

Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced  that he will pursue a “step by step” approach to crafting major biomedical innovation legislation.  This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan.

First Court Decision Interpreting the Overpayment Rule Issued This Week

Earlier this week, a key decision denying defendants’ motion to dismiss was issued in the case, Kane v. Healthfirst Inc., et al. and United States v. Continuum Health Partners Inc., et al. (case no. 1:11-cv-02325, S.D.N.Y.). This is the first court decision to interpret a provision of the Affordable Care Act that requires a […]

21st Century Cures Passes House of Representatives; Ups the Ante for HHS Grant and Contracting Fraud

Earlier today H.R. 6, “21st Century Cures”, passed the House of Representatives by an overwhelming vote of 344-77.  Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent grants and contracting with the Department of Health of Human Services (HHS). According to a summary of the bill […]

Supreme Court Upholds Federal Exchange Tax Subsidies in King v. Burwell

Today, the Supreme Court issued its highly anticipated ruling in King v. Burwell.  The case questioned whether individuals who purchased health insurance through the federal Healthcare.gov marketplace were entitled to receive tax subsidies pursuant to the Patient Protection and Affordable Care Act (ACA), or whether such subsidies were reserved for individuals who purchased health […]

Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion […]