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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. 
Mintz’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”).
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.
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.

The New Extender Timeline

February 8, 2018| Blog

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.
Mintz’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.
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).
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.
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 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.
Two new DOJ policies about False Claims Act enforcement became public last week. 
This week, President Trump will deliver his first State of the Union address to a joint session of Congress. Following his speech, both parties will leave town for party retreats where they will discuss priorities for the year ahead.
Last week, Governor Andrew Cuomo unveiled his proposed $168 billion budget for fiscal year 2019, which proposes several changes to New York’s healthcare landscape.
Last week, Mintz released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA).
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.
Rules for clinical research are undergoing major changes in both the United States and the European Union.
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates. 
Today is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. 
Congress has four days to fund the government. The emerging spending deal could include any number of legislative priorities. We will wait and see for signs that a spending deal is close before we start envisioning what a short-term continuing resolution might look like.
On January 11, 2018, CMS released a Letter to Medicaid Directors outlining guidance that work requirements can be used as a basis for eligibility for certain adult Medicaid beneficiaries through 1115 waivers.
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