As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.  Earlier this month, the Department of Justice (DOJ) announced that a Michigan physician, Dr. Rodney Moret, was sentenced to 75 months in prison for his role in conspiracies to distribute prescription pills illegally and to defraud Medicare. The conduct alleged against Dr. Moret is particularly extreme, but nevertheless reflects the government’s commitment to ferreting out opioid-related misconduct. Continue Reading Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

Mintz Levin’s Antitrust & Federal Regulatory Practice recently published a Health Care Antitrust Alert on the DOJ Antitrust Division’s announced settlement with Henry Ford Allegiance Health (“Allegiance”). The settlement concludes nearly three years of litigation involving claims that Allegiance and rival hospitals unlawfully conspired to restrict the marketing of competing services in some South Central Michigan counties. We published an Alert when the claims were first filed in 2015. The new Alert outlines the terms of the proposed settlement agreement.

Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. In health care, the President’s budget focuses on prescription drug pricing and opioid funding. It included a number of legislation proposals relating to Medicare Part D, as well as the creation of a Medicaid demonstration allowing states to test new financing structures to cover prescription drugs. The proposal also discusses the future of the Affordable Care Act, including the Medicaid expansion, as well as appropriating cost-sharing reduction payments for FY 2018 through the end of calendar year 2019. Proposals in the budget that are regulatory in nature are certainly items worth monitoring since its likely they would be approved and implemented under this Administration.

We cover this and more in the budget analysis, which can be found here.

 

 

This week, the President’s FY 2019 budget will be released, and the Administration will spend the next couple of weeks touting its goals. How this activity is received in Congress will play out in various committee hearings, as will issues like drug pricing, which the Administration is closely examining.  On the regulatory side, is this the week that we finally see action on short-term limited duration insurance plans? We cover what that could mean and more in this week’s health care preview.

Based on the most up-to-date information on the budget deal, we have developed a new timeline for the major health care extenders. This new timeline is important because these provisions were once all tied together and now, they are not.

Click here for the health care extender timeline.

*Note this post assumes the budget deal will pass tonight and is based on information as of 4:00pm on February 8, 2018.

**Emma Zimmerman of ML Strategies contributed to this post.

Mintz Levin’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.  Highlights from this Update include:

  • a relatively high rate of intervention;
  • cases filed in 30 different courts;
  • cases brought against a variety of different health care providers;
  • almost half of the cases filed by current or former employees; and
  • faster times for unsealing cases.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Releases New Qui Tam Update

Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice and Call Letter). The Advance Notice and Call Letter should be read hand-in-hand with the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for the Medicare Advantage (MA) CMS-HCC Risk Adjustment Model (2019 MA Risk Adjustment Changes) that CMS released on December 27, 2017.  Both documents request comments from interested parties and have a submission deadline of March 5, 2018. Continue Reading CMS Releases Advance Notice and Call Letter for Medicare Advantage and Part D

Late Monday night (February 5, 2018), the House of Representatives released a continuing resolution to keep the government funded and running until March 23, 2018. This CR includes many health care related provisions, specifically many of the health care “minibus” riders. In the chart below we summarize major health care provisions in this CR specific to the health care minibus. Note, the entire CHRONIC Care Act is included in this CR. Additionally, two key health care provisions are not included in this CR – the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) and the Money Follows the Person (MFP) program. Please click here to see our chart summarizing key health care provisions of the February 5 CR.

 

This week, Congress needs to pass a government funding bill by Thursday. Will we get a final budget deal or another continuing resolution? There are still several important health care programs that need to be addressed as well as health care initiatives that have bipartisan support and could find their way into a deal. The challenge for Leadership this week is putting together a deal that can pass without upsetting the delicate balance in the House of Representatives. We cover this and more in this week’s preview, which can be found here.

The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state’s Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers. The new rules place the burden of compliance on prescribers licensed in New Jersey, but manufacturers should be fluent in these requirements.  We expect engagement and collaboration with New Jersey prescribers to be impacted, as these rules are clearly designed to be a disincentive to financial arrangements between manufacturers and prescribers.  How deeply this impacts ongoing and new collaborations with prescribers is yet to be seen, as manufacturers do rely on prescribers for contributions to product design, product feasibility in clinical workflow, and patient expectations. Below is a summary of the key aspects of the new rules, along with tables to assist in identifying how certain payments are affected.  Continue Reading A Guide to New Jersey’s New Limits on Pharmaceutical Industry Payments to Prescribers