Biosimilars – FDA approves Biosimilar for Remicade®

Posted on 21. Jul, 2016 by .

On April 5, 2016, the FDA approved Celltrion’s infliximab-dybb (Inflectra™) as a biosimilar to Janssen’s Remicade® (reference product). Celltrion will partner with Pfizer to market Inflectra™ in the U.S. Inflectra™ is the second biosimilar approved by the FDA, after Sandoz’s filgrastim-sndz, Zarxio®, approved in early 2015 as a biosimilar of Amgen’s Neupogen® (filgrastim) for the [...]

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$900 Million is Largest Enforcement Action Related to Healthcare, Ever!

Posted on 18. Jul, 2016 by .

Recently, the US Department of Justice announced it had concluded an unprecedented nationwide sweep led by the Medicare Fraud Strike Force in 36 federal districts. The sweep resulted in criminal and civil charges against 301 individuals, including 61 doctors, nurses and other licensed medical professionals for their alleged participation in health care fraud schemes involving [...]

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FCA 2013 Patterns Set 2014 Trends

Part D Enhanced Medication Therapy Management Model

Posted on 14. Jul, 2016 by .

On March 16, 2016 via HPMS, CMS announced the release of the Medication Therapy Management (MTM) pilot audit protocol for the 2016 calendar year and provided an update on the Provider Network Accuracy (PNA) pilot. The MTM pilot protocol, similar to the audit process documents for existing program audit areas, defines the audit purpose, universe [...]

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Proposal to Reduce Exclusive Market Time for Biologic Medicines

Posted on 11. Jul, 2016 by .

Recently, a bill has been introduced to reduce the time companies have to market biologic medicines. Specifically, the bill is requesting to amend the Public Health Service Act. The goal is to shorten the exclusivity period for brand name biological products from 12 to 7 years. Janice Schakowsky, who is a Democrat from the state [...]

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CMS Part D Prescriber Enrollment Requirements- Delay in Enforcement

Posted on 08. Jul, 2016 by .

In an HPMS Memo released on March 1, 2016, CMS announced that they are delaying enforcement of the Part D Prescriber Enrollment Requirements until February 1, 2017, to ensure that they could enforce these requirements in a way that would minimize the potential for disrupting beneficiaries’ access to needed Part D medications. CMS feels that [...]

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What is the Expedited Access Pathway (EAP)

Posted on 05. Jul, 2016 by .

The EAP is a program to facilitate the development of and access to new technology for patients suffering from life-threatening conditions who desperately need medical devices of public health importance. About a year ago, the FDA’s Center for Devices and Radiological Health created the voluntary program.  As the FDA states: The EAP program represents a [...]

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Best Practices for Part C and D Plan Reported Data Validation

Posted on 01. Jul, 2016 by .

CMS has been focusing on Data Validation Training Best Practices for Part D and C Reviewers. CMS released an HPMS Memo titled “Best Practices for Part C and D Plan Reported Data Validation” on March 31, 2016. This memo included information regarding data validation which will take place from April 1, 2016 – June 30, [...]

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Match Learning to the Right Design Strategy

Posted on 27. Jun, 2016 by .

One way to make learning as effective as possible is to match the right learning design to the right content. Too often, when designing instruction, the same approach is used regardless of the type of content to be taught. This, it turns out, is not an effective strategy. Different types of content should be taught [...]

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