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 MoreWe’ve documented our processes here so you know exactly what to expect after you click one of the Get Started buttons on our website.
As always, we want our Provider, Digital Health, and Life Sciences clients to be informed, prepared, and confident in their decisions so they can innovate faster and grow their businesses.
Read MoreA Final Rule published by CMS makes several important changes to the Stark Law that will be a boon for physicians eager to more closely coordinate with other providers to (1) better manage patient care and (2) to participate in the shift to value-based reimbursement.
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.
Medical providers across the spectrum have endured a significant hit to revenues as a result of the COVID-19 public health emergency (PHE). MGMA’s recent report, “COVID-19 Financial Impoact on Medical Practices”, indicates that nearly 100% of providers have seen a negative revenue impact, with an average decrease in revenue of 55%. To offset some of those losses, the CARES Act allocated a $50 billion “general allocation” to support the sustainability of these providers.
Read MoreFor nearly two years, digital healthcare companies and data brokers from across the country have been preparing to comply with California’s newest data privacy law—the California Consumer Privacy Act of 2018 (CCPA). Companies are making determinations about the applicability of this law to their operations, developing inventories of the types of consumer information they collect, and implementing operational and procedural changes in order to comply with the requirements of the law’s requirements. For those companies whose operations are not subject to the CCPA law, some have determined that it may be a strategic advantage to voluntarily adhere to some of the CCPA’s requirements, as they are likely to be adopted by other states (and even the Federal Government) as privacy legislation continues to proliferate. If you are a digital healthcare company or healthcare data broker and you’ve not initiated these conversations within your company, now is the time.
Read MoreIn this article, we focus on the proposed Care Coordination Arrangements safe harbor to the Anti-Kickback Statute and discuss how this new safe harbor may affect vendors of care management services such as Remote Patient Monitoring, Chronic Care Management services, Transitional Care Management services, and Behavioral Health Integration services.
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 MoreOn Tuesday, the Federal Trade Commission (the “FTC”) released three warning letters to unnamed companies who were illegally advertising their CBD products.
Read MoreThe Virginia Cannabis Industry Association (VCIA) will host a series of regional legislative forums over the next several weeks. Discussions will include an update about the Virginia cannabis industry and how outcomes of the November elections of all 140 seats of the Virginia General Assembly may affect the opportunities and challenges of this nascent industry.
Read MoreFollowing its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).
Read MoreThe Virginia Department of Agriculture and Consumer Services (“VDACS”) Commissioner Jewel Bronaugh sent a letter (the “July Letter”) to all Virginia-registered Industrial Hemp Processors (“Processors”) on July 15, 2019 notifying the Processors that Governor Northam’s office has directed VDACS to “treat hemp-derived extracts intended for human consumption as approved food additives and to place qualifying Registered Industrial Hemp Processors under food safety inspection so that inspected and approved processors may manufacture a hemp-derived extract for human consumption.”
Read MoreNixon Law Group represents clients whose businesses are on the leading edge of healthcare and technology. We represent healthcare providers, healthcare technology companies, and other businesses that sell to the healthcare industry, including businesses in the medical cannabis industry.
Read MoreIn Virginia’s 2019 General Assembly (GA) Session, five of six proposed cannabis-related bills passed and will soon reach the desk of the Governor, ushering in some significant changes to the Commonwealth’s medical cannabis program. Among them, allowing full therapeutic-strength medical cannabis preparations, and the addition of physician assistants and nurse practitioners to the list of providers permitted to make medical cannabis recommendations.
Read MoreHaving written a series of posts over the years addressing employment contracting from the physician perspective, one of our readers reached out to let us know that Nixon Law Group should, likewise, address physician/clinician employment contracting from the perspective of the healthcare employer. Considerations for Clinician Contracting – An Employer Perspective…
Read MoreThis Advisory Opinion demonstrates OIG’s willingness to remove barriers to adoption of healthcare technologies - such as lack of access to a smartphone - that may improve patient outcomes and reduce overall costs of care.
Read MoreSmart physicians are not immune from making highly regrettable mistakes when it comes to employment contracts. And unlike in medicine, you don't get the option of trying a new treatment plan if the first one doesn't work. Physicians are educated, and intellectually sophisticated. This means that, even though you weren’t trained to read legal contracts in medical school, courts expect that you have read and fully understand the terms of the contracts you sign. That means that, both during and even after your employment, you're stuck with the contract you sign, so make sure you avoid these common pitfalls.
Read MoreOn January 9, the 2019 General Assembly Session will convene, and there are several bills that are set to be introduced that may have an impact on Virginia healthcare providers. We will update this post with additional legislation as session progresses.
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