While we continue to follow the recreational marijuana legalization saga and the Massachusetts Department of Public Health’s Medical Marijuana Program, our colleagues on the employment law side of the equation are monitoring decisions regarding the ability of employers to take disciplinary action against employees for using marijuana at work.  This blog post discusses an important new decision issued by the Massachusetts Supreme Judicial Court, Barbuto v. Advantage Sales and Marketing, LLC, in which the Court concluded that, under the circumstances in that case, employers must accommodate medical marijuana users in the normal course to avoid violating the state’s antidiscrimination laws when it fires an employee because of a failed drug test based on the employee’s use of medical marijuana. It’s a must read for employers grappling with this emerging area of employment law.

 

Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force.  As part of the national health care fraud takedown, the government charged 412 defendants with approximately $1.3 billion in alleged fraud. In addition to these charges, HHS Office of Inspector General (“OIG”) is in the process of excluding 295 health care providers from participating in federal health care programs.

Continue Reading DOJ and OIG Announce Largest Ever National Health Care Fraud Takedown; Focus on Opioids

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the Better Care Reconciliation Act (BCRA), the User Fee Acts (UFAs), the National Defense Authorization Act (NDAA), and the health care Minibus.

Stay tuned for additional updates and analysis from ML Strategies.

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.”

I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered entities’ acquisitions cost.”   Continue Reading Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance documentContinue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus

Stay tuned for additional updates and analysis from ML Strategies.

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” Continue Reading FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

Earlier this month, two states – Maryland and Nevada – passed legislation aimed at controlling drug prices. The two laws are being touted by proponents as decisive action against pharmaceutical manufacturers. Opponents note that the laws have limitations and are really more of an annoyance for drug makers and will not do anything to help patients access or afford their medicines. Notably, both measures were enacted without the governors’ signatures (who are both Republican) but neither governor vetoed the legislation.

Continue Reading Drug Makers Not Off the Hook as States Continue to Take Action to Control Drug Prices

The Massachusetts legislature has targeted July 1, 2017 as the date by which it will have legislation on Governor Charlie Baker’s desk regarding the commercial cultivation, processing, and sale of non-medicinal cannabis products for adult use. On June 23rd, the House and Senate each appointed members to a 6-member conference committee that is tasked with resolving the differences between the (renumbered) House and Senate bills, H.3776 and S.2097. There are a number of differences to be addressed, including taxation, enforcement, and the ability of communities to limit or prohibit the establishment of cannabis businesses, even when a community has allowed a registered medical marijuana dispensary. ML Strategies has issued a Client Alert summarizing the progress of this issue from passage of the November 16, 2016 ballot question establishing “recreational” production and sale of cannabis products, through this most recent legislative activity. Stay tuned for further coverage.

Children in United States receive their health insurance from multiple sources: the Children’s Health Insurance Program (CHIP), Medicaid, employer-sponsored insurance, or a qualified health plan on the Marketplace. This creates a fragmented system of coverage for children and families, particularly for low- and moderate-income families, who often have children and parents enrolled in across separate coverage sources.

With CHIP funding scheduled to expire on September 30, 2017, the future of children’s coverage will be up for debate again. Proposals have called for an extension of CHIP funding. However, as Katie Weider and Rodney Whitlock of ML Strategies discuss in their latest Health Affairs blog, it is time for us to stop talking about CHIP, and instead start talking about integrating the myriad of children’s coverage sources.  That blog is available here.