In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more
References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private...more
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
Continuing with our review of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”), this post highlights a number of uncertainties that will be faced in implementing the...more
As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The...more
With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more
As you know, the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) was released earlier this week, and we are highlighting its major sections as stakeholders prepare to submit...more
GAO recently released a report analyzing the use of pharmacy benefit managers (“PBMs”) and efforts to manage drug spending and use in the Medicare Part D program. Importantly, the report found that use of PBMs reduced Part D...more
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
5/29/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Gag Clauses ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more
2/7/2019
/ Advance Notice ,
Bipartisan Budget Act ,
Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Healthcare ,
Medicare Advantage ,
Medicare Part D ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Adjustment Formula
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more
3/5/2018
/ Advance Notice ,
Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Healthcare ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs
Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more
The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more
10/24/2014
/ Co-payments ,
Coupons ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
Trends & Analysis -
Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more