The U.S. Department of Justice (DOJ) just sent a strong message to pharmaceutical and biotechnology companies who rely on contracted sales teams to push their products into the market: “commission-based compensation violates the Federal Anti-Kickback Statute (AKS)”.
This message seems to undermine years’ worth of relative stability in how these companies evaluate risks associated with commission-based compensation that does not fit squarely into a legal safe harbor under the AKS.
Read MoreWith “Episode 3: 5 Tips from the Negotiation Table,” Tommy and I will dive into the following topics that should be relevant for every investor, founder, and CEO: Have a solid but flexible strategy/commercialization plan; Know and understand your competitive landscape, and how you will fit into/disrupt it.; Begin your company with the end in mind – preparing for exit; Be well-prepared in highly regulated industries (regulatory paths, documentation, marketing, information systems); What are your use cases and who is paying?
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Join us as Tommy Miller, Sr. Counsel and Life Science Lead at Nixon Law Group, speaks with industry experts, John Lazo and Nikki Hastings, about how the global COVID-19 pandemic has impacted pharmaceutical drug development. The panel will discuss how innovators are responding to the pandemic through new tests, devices and therapeutics and how the drug development ecosystem can implement "lessons learned" to help us better prepare for the future of drug discovery.
On January 21, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized a decision (under National Coverage Determination (NCD) 30.3.3) to cover acupuncture for Medicare patients, specifically those with chronic low back pain (cLBP).
Read MoreWelcome to January 2020! I am Tommy Miller, I am Senior Counsel, and life science practice lead here at Nixon Law Group. Today I want to walk you through what I think are the highs and lows of 2019, specifically related to the legislative and regulatory actions taken in the pharmaceutical and medical device space.
Read MoreThe lines between health data and consumer data are increasingly blurred as more technology companies venture into healthcare analytics and data processing. Why does this matter? Because there are state and federal laws protecting healthcare data collected by a person’s insurance company or physician, but for-profit companies that may collect healthcare and other sensitive person data are often not subject to these laws. In addition, healthcare companies subject to state and federal healthcare privacy laws are increasingly leaning on third party technology companies to derive value or insight from the healthcare data they collect in ways that would surprise many consumers.
Read MoreDespite division along party lines and industry pushback, the House of Representatives has passed legislation (H.R. 3), the “Lower Drug Costs Now Act”, which would require the Department of Health and Human Services (DHHS) to establish a “Fair Price Negotiation Program” responsible for negotiating Medicare payments for some of the most expensive drugs available to Medicare beneficiaries.
Read MoreIn a pair of proposed rules released by the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), the DHHS is looking to increase the utilization of value-based arrangements to drive health outcomes and ease the regulatory burdens associated with patient care coordination. The proposed rules seek to change or add certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral prohibition (Stark Law), and the Civil Monetary Penalties (CMP) laws.
Read MoreWhen developing new medical device and drug products, it is important to understand how the product will be adopted and paid for in the marketplace. The development of new drugs and devices involves countless hours researching, testing, modifying, iterating, and testing some more… In larger companies, whole teams of people also dedicate the same effort into developing a market access plan—meaning careful planning for manufacturing, distribution, and insurance contracting. This strategic planning can be overlooked in start-up biotech companies operating on limited resources and which are squarely focused on innovating new technologies.
Read MoreThe FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices. The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program.
Read MoreHospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019. In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.
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