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.
UPDATE: Shortly after this post went live, Senate Majority Leader Mitch McConnell announced that he would be delaying the vote on the Better Care Reconciliation Act until after the Fourth of July recess. Stay tuned for further updates and analysis from the team at ML Strategies!
The Senate bill to repeal the Affordable Care Act is currently being poured over by Senate Republicans and their staff, but the early prognosis for a vote this week is not good. Senate leadership had set a goal of voting on this legislation – known as the Better Care Reconciliation Act (BCRA) – before the Fourth of July recess, which means by this Friday. However, calls for more time to review the bill as well as concerns over certain key provisions – like those touching Medicaid – may stall Senate progress at a critical moment for health care repeal efforts. Here’s where things stand: Continue Reading Capitol Hill Update: Affordable Care Act Repeal on the Ropes?
On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of July 31, 2017. As explained in our earlier post, CMS publishes Part D DIR Reporting requirements each year and sets the deadline for DIR submissions.
These DIR Reporting Requirements are the first to require Part D plan sponsors to report as DIR price concessions from and additional contingent payments to network pharmacies that could not reasonably be determined at the point of sale. This change is caused by the update to the definition of “negotiated prices” that was effective January 1, 2016. Not surprisingly, most of the comments and responses included in CMS’s Reporting Requirements focus on this change. Additional topics addressed in the comments and responses include, but are not limited to: (i) plan sponsors no longer being able to report negative amounts in the rebate fields, (ii) the timeliness of the DIR data submitted by July 31, 2017; and (iii) confidentiality of DIR data reported to CMS.
Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year. Join our upcoming webinar – “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET. Colleagues in our Health Care Enforcement Defense Practice Group will help companies better understand how to deal with FCA cases, which result in billions of dollars of recovery for the government each year. Hope Foster, Larry Freedman, Karen Lovitch and Ellyn Sternfield will share insights to the relator process, help companies understand how to react if it is named in a whistleblower suit, and provide tips for how to prevent them.
A New Jersey district court recently denied a motion to dismiss Talone, et. al. v. The American Osteopathic Association, an antitrust class action. The suit alleges that the physician association violated the Sherman Act by illegally tying osteopaths’ board certification to association membership. The defendant association moved to dismiss, arguing that plaintiffs, a group of affected doctors, had failed to allege sufficient facts to demonstrate foreclosure of competition or antitrust injury. This alert reviews plaintiffs’ claims, the association’s arguments against them, and the court’s denial of the association’s motion to dismiss.
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected promulgating regulations that would make any action “that directly or indirectly suggests to the physician or to the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised” (37 Fed. Reg. 16,503, 16,504) into a matter warranting enforcement action, the Agency used this reasoning to shape an off-label communication policy. As I described in Part 2, FDA’s policy enjoyed some support from federal courts; however, this support was only temporary. More recently, federal courts have shown support for the idea that truthful and non-misleading promotions of off-label uses of drugs and devices by manufacturers are protected under the First Amendment. A review of the pivotal cases in this area will help put FDA’s off-label policy in perspective, especially in light of FDA’s reaction to these cases in a memorandum published in January 2017. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3
Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating. The ruling confirms that private needle exchange programs — an important tool in combating the spread of HIV and hepatitis C associated with injection drug use — can continue in Massachusetts as the Commonwealth copes with an ongoing opioid epidemic. My Mintz Levin colleagues, Andrew DeVoogd and Tiffany Knapp, and I drafted an amici curiae brief in the case in support of the plaintiff’s position on behalf of approximately thirty public health organizations, healthcare providers, and payors. Continue Reading Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.
Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application. Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs