The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of market-based pricing reform for Medicare-reimbursed lab tests.
It also increases the range of applicable labs so that the prices become realistic and reflect that of the entire lab market. This change to the ACA thus can considerably scale down Medicare reimbursement prices on sophisticated, high technology tests that are routinely required. The trickledown effect of this Final Rule thus is that it is expected to consolidate the clinical lab services market, making it imperative for the in-vitro diagnostics market to develop elements such as biomarkers and assays routine.
And now, the new regime…
These expected changes have to reckon with the possibility of the whole system of affordable healthcare, the soul of Obamacare, undergoing changes with the inauguration of the new US President, Donald Trump, in early 2017. In line with his strong electioneering emphasis on repudiating the whole idea of affordable healthcare, among the first executive orders that he signed barely days into his presidency, he strongly exhorted his party to dismantle the plan. This is being seen in the administrative and healthcare circles as a sure first step towards its replacement.
Although the final annulment of Obamacare, if it does indeed come about, will take months and perhaps even years to materialize, it is something that can be expected of the new administration. All this has brought about a new phase of uncertainly about the very existence of Affordable Care Act, whose impact on the in-vitro diagnostics market was beginning to just get felt, as we saw.
Plus, regular factors that affect the IVD market
While all these are the crucial factors that can bring about changes to the in-vitro diagnostics market and make a difference to the industry; there is also the set of regular scenarios that need to be taken into consideration by those who design, code, manufacture, sell, buy, use or order in-vitro diagnostics. It is that the FDA keeps coming up with new plans for the industry every now and then. these could make a huge impact on those in the in-vitro diagnostics business.
In what ways do changes mean in in-vitro diagnostics for professionals in the industry and how does it affect them in the pursuit of their business objectives? A webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will seek to answer these questions.
At this webinar, Anna Longwell, who is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law, will be the speaker. To register for this highly valuable learning session, please visit
Anna will take up important topics related to in-vitro diagnostics, such as how a business or practice may get affected by the changes taking place in the in-vitro diagnostics area.
She will follow it up with a review of the FDA’s draft plans for Medical Device User Fee and Modernization Act (MDUFMA), the Laboratory Developed Test (LDT) vs. IVD issue, the approach to globalization embodied in the proposed acceptance by FDA of the International Medical Device Regulators Forum (IMDRF) Software guidance, the drug and medical device development tools programs (biomarkers), Software as clinical decision assistance and Multi-Analyte tests such as DNA NGS.
This webinar will cover the following areas:
· Basic Definitions
o Label, Labeling, Advertisement
o Intended Use, Indications for use
· Off-label Use
o The Recent Acclarent Indictment
o Scientific literature and Freedom of Speech
· Prescription vs OTC
· in-vitro diagnostics a Special Case (21 CFR 809): RUO and IUO
· “Restricted Devices”
· Electronic Labeling
· Marketing practices Interactions with HCPs