CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.

In November of 2017, in the proposed Medicare Advantage and Part D regulations for CY 2019 CMS set out a framework for Part D plans to monitor and reduce the potential misuse of prescription opioids. Continue Reading CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

Congress is back in session and will begin its work in finalizing a final spending bill for fiscal year 2018. Both chambers are considering new ways to address the opioid crisis, and we should expect a renewed push around gun control and mental health. We cover this and more in this week’s health care preview.

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

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.

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

Last week, Mintz Levin 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). The Advisory summarizes the notification requirements as well as the risks associated with failing to provide the required information, including removal of a manufacturer’s drug products from the active section of FDA’s Orange Book. The data submission requirements are part of the FDA Reauthorization Act (FDARA), which aims to improve FDA’s ability to track drug products in the commercial marketplace and represents one of Congress’ attempts to control drug pricing and address patient access issues for prescription drugs.

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.

After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018

Rules for clinical research are undergoing major changes in both the United States and the European Union. In the United States, the 21st Century Cures Act, which was signed into law on December 13, 2016, creates a new paradigm for modern trial design and clinical evidence development, and the Department of Health and Human Services has proposed significant revisions to the Common Rule, which governs human subject research. In the European Union, imminent changes to the clinical trial regulation No. 536/2014 and general data protection regulation could substantially impact the administration of clinical trials in European countries. The changes will greatly affect the conduct of clinical trials by sponsors and clinical researchers all over the world.

To find out more about these changes and how to address them in your trials, join our two-part upcoming webinar, “Conducting Multi-Jurisdictional Trials: Understanding Changes in the US and EU.” The first part, on January 24 at 11 AM EST, will feature Bethany Hills, Dianne Bourque, and Benjamin Zegarelli from Mintz Levin’s FDA practice group, who will share insights on changes that will impact the design and conduct of clinical trials in the US. The second part, on February 7 at 11 AM EST, will feature Laura Liguori and Elisa Stefanini from Portolano Cavallo, who will cover the important changes to clinical trial administration in the EU and Italy.

Register now!

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary. Mr. Azar was more recently an executive at Eli Lilly and Company. As summarized here, Mr. Azar received many questions regarding Medicaid, CHIP, the Affordable Care Act, and most notably and often, drug prices. Continue Reading Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners.  Among the factors that may have resulted in the uptick in cases against individuals are the Yates Memo issued in late 2015, improved and increased reliance on sophisticated data analytics, and the aggressive focus on opioid addiction and its causes. Continue Reading Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends