On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from Canada, and a Final Guidance describing procedures to allow manufacturers to obtain National Drug Codes (NDC) for FDA-approved drugs originally intended to be marketed in a foreign country ( referred to as “multi-market approved products” or “MMA products”).… More
There is no shortage of discussion about the risks that inadequate cybersecurity poses to today’s healthcare ecosystem. While increasingly prevalent connected devices offer many advantages to patients and clinicians alike, hackers can potentially exploit their vulnerabilities for malicious purposes.
With connected devices here to stay, why do MedTech manufacturers and healthcare providers consistently struggle with security, and how can this situation be improved? In this forum, we will explore how primary stakeholders in the healthcare ecosystem can develop and leverage devices in a way that provides tighter security against the threat of cyberattacks.… More
We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an ongoing saga on a different aspect of the 340B program – the growing presence of contract pharmacies in the 340B space, and recent efforts by drug companies to curb this trend.… More
Before getting into the weeds of how notice-and-comment rulemaking requirements interact with CMS’s ability to set payment policy – Medicaid and the Law would like to formally introduce its readers to Alexander Somodevilla (Alex), a new Associate in the Washington, DC office who will become a regular contributor to the blog. Alex has a deep background in Medicaid and Medicare law and policy, and is passionate about the issues and far-reaching impact of these programs.… More
We’ve written before about the 340B program, which allows some health service providers that treat low-income patients to purchase outpatient prescription drugs at deeply discounted prices. It’s related (at least tangentially) to our blog because of the link between the 340B program and the manner in which the Medicaid program pays for outpatient drugs; essentially, the price that a 340B covered entity pays for a drug is the price that Medicaid would pay for the drug when it’s dispensed to a Medicaid patient: at least 23.1% off of the manufacturer’s price of the drug.… More
Last month, we described the announcement by the Department of Health and Human Services (HHS) announcing the allocation to Medicaid providers under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. In the past couple of days, HHS has updated its policies regarding the Medicaid allocation (including the allocation to safety net providers) and we thought now would be a good time to highlight those updated policies.
By way of background,… More
My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or MDRP. Today, we turn our attention to another provision of that proposed rule, and that is CMS’s attempts to permit pharmaceutical manufacturers, states, and commercial payers to enter into value based payment arrangements for covered outpatient drugs. … More
As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including new regulations to encourage the development value-based purchasing arrangements between states and manufacturers. Over the next several days we will be posting our thoughts on a number of these key policy proposals, including CMS’… More
Well, we’ve been waiting for awhile and now it’s been made public: the Department of Health and Human Services (HHS) announced on June 9 that it was releasing $25 billion in funding from the Coronavirus Aid, Relief and Economic Security (CARES) Act to high Medicaid providers and to safety net hospitals. President Trump signed the CARES Act into law on March 27; the CARES law and a subsequent law appropriated $175 billion to a Provider Relief Fund to address the needs of healthcare providers that had increased expenses or lost revenues due to COVID-19. … More
“Social distancing,” a euphemism for an infection prevention and containment strategy, will undoubtedly live in the annals of meme history for its incredibly disrupting effects on the world. Fortunately, advancements in technology that allow one to upload the same memes to the internet have also enabled medical providers to respond to the COVID-19 pandemic by furnishing medical care, also known as “telehealth” or “telemedicine,” to their patients in the comfort (and safety) of their own homes,… More