
FDA actions in brief, fast-track designation, orphan drug designation, first-time generic approvals

FDA actions in brief, fast-track designation, orphan drug designation, first-time generic approvals

Prepare for a significant increase in self-pay liabilities from the “high-deductible“ patient population or risk a reduced level of reimbursement

Community Health Choice CEO Ken Janda foresees more private coverage for the state and the country under health reform 2.0

Payment changes will save an estimated $200 million annually.

Mammograms contribute 62% of the cost and the remaining 38% is attributed to follow-on diagnostics.

Coverage of circulating tumor cell (CTC) assays could be discontinued for beneficiaries in certain states.

Bronze plans have highest drug cost-sharing increase.

CMS is driving down rates for MA plans while taxes and dwindling bonus pay pile on the pain

Value-based designs aren’t just nice add-ons, but rather they represent new business propositions

Who knows how many late-comers will plea for special enrollment

One-fourth of Akron Ohio's SummaCare enrollees are among the coveted younger population

Break down silos to improve access and affordability

Medicare patients incur higher out-of-pocket costs when they are placed on observation status

Influenza vaccination reduced children’s risk of pediatric intensive care unit (PICU) admission for flu by three-fourths during 2010 to 2011 and 2011to 2012, according to a Centers for Disease Control and Prevention (CDC) study published online March 26 in the Journal of Infectious Diseases.

Idarucizumab (Fab, Boehringer Ingelheim), an investigational humanized antibody fragment being studied as a specific antidote for dabigatran (Pradaxa), reversed dabigatran anticoagulation, even in the presence of elevated dabigatran levels and life-threatening bleeding from severe trauma, in animals, according to a study presented at the American College of Cardiology 63rd Annual Scientific Session (ACC.14), Washington, D.C.

Data from a phase 3 study comparing the low-density lipoprotein-cholesterol (LDLc)–lowering efficacy and safety of alirocumab, an investigational PCSK9 inhibitor, versus ezetemibe in patients not receiving statin or other lipid-lowering therapies was presented at the ACC.14, the American College of Cardiology’s 63rd Annual Scientific Session & Expo in Washington, D.C.

FDA has approved Coagulation Factor IX (Recombinant), Fc Fusion Protein (Alprolix, Biogen Idec), for use in adults and children who have hemophilia B; it also granted the product orphan-drug designation. Alprolix is the first hemophilia B treatment designed for less frequent injections when used to prevent or reduce bleeding frequency.

Just like most of the Affordable Care Act implementation, the enrollment deadline is causing plenty of consumer confusion

Official HHS guidance for plans and consumers

National insurers won't be able to compete on price

A delay for ICD-10 will not delay ICD-11

The industry cost of ICD-10 implementation will total $8 billion, meanwhile many organizations have yet to move to the highly recommended testing phase

Enrollments rolling in despite consumers' lack of knowledge, technical glitches and high-traffic volumes.

Lack of substantial prescription drug coverage was found to be associated with financial decline in breast cancer survivors, according to an article published in the Journal of Clinical Oncology.

To successfully navigate the structural break in healthcare, payers need to boost investment returns through strategic clarity, resource alignment, and supportive organizations

The American Society of Health-System Pharmacists (ASHP), the Institute for Safe Medication Practices (ISMP), the American Hospital Association (AHA), and other healthcare groups have developed a number of long-term strategies to address drug shortages and released their recommendations in a report, ASHP announced last week.

Oxycodone hydrochloride and acetaminophen (Xartemis XR, Mallinckrodt) Extended-Release Tablets (CII) were approved for the management of acute pain requiring opioid treatment. Xartemis XR has been specifically formulated to reduce abuse, according to the drug’s manufacturer.

FDA has approved apremilast (Otezla, Celgene), an oral, selective inhibitor of phosphodiesterase 4 (PDE4) to treat adults with active psoriatic arthritis (PsA).

Hardship exemptions aren't clear enough for consumers to take a chance on special enrollment period

Connecticut and Washington will not offer extensions