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Interview with H. D. Smith’s – Third Party Network manager Katie Geisler to talk about the importance of Medicare Part D enrollment and reimbursement changes in 2016.  (podcast)

A pill meant to prevent HIV infections in high-risk individuals appears to be working, according to two new studies…in…San Francisco…there were no new HIV infections…people who took the daily pill Truvada (emtricitabine and tenofovir)…in the UK taking Truvada had a lower risk of being diagnosed with HIV…

Fourteen years after the 9/11 attacks, a new round of uncertainty looms for people exposed to the million tons of toxic dust that fell on New York when hijacked jets toppled the World Trade Center….Two federal programs that promised billions of dollars in compensation and medical care to sick 9/11 responders and survivors are set to expire next year, five years after they were created by Congress.,, As Friday's anniversary of the terror attacks approached, advocates for responders renewed their push for an extension…Almost 21,600 people received treatment through the World Trade Center Health Program over the past year,… officials haven't been able to say how many patients might lose access to doctors or medication if the program shuts down as planned next September.

Smart medicines that tell doctors when their patients have taken them moved a step closer to reality after a company developing the first "digital pill" had its drug application accepted…the pill, produced by Proteus Digital Health, will help ensure patients stick to their prescriptions…Food and Drug Administration had agreed to review its device which is embedded in a schizophrenia medicine (aripiprazole)…new regulatory pathway that allows the pharmaceuticals industry to combine its medical innovation with innovation in software.."smart pill" contains a tiny ingestible sensor that detects when the drug has reached the stomach…It communicates with a wearable patch…then transmits the information to a mobile device.

Americans today rightly demand more transparency...It is the foundation upon which to assess accountability, performance and trust… the Senior Care Pharmacy Coalition — a coalition dedicated to representing the exclusive legislative and regulatory interests of independent Long Term Care pharmacies and the vulnerable patients they serve — hopes to work with Congress on reforms that both increase transparency in drug pricing practices and ensure protection against Medicare Part D pricing policies that hinder LTC pharmacies’ ability to delivery quality pharmaceutical care and services...

When the clock ticks in a new month and the entire healthcare industry is thereby mandated to begin using the new ICD-10 code set, there will most likely be glitches here and there…given the limited testing…that has taken place to date, it's impossible to predict with certainty whether those will be small and easily ironed out -- or significant enough to severely disrupt cash flow and launch more downstream problems…some organizations are establishing ICD-10 command centers…a help line to triage savvy billing, IT or coding representatives...

..Department of Health and Human Services is making it easier for patients with shoulder injury related to vaccine administration to be compensated for their pain….In order to capture the broader array of potential injuries,… the Secretary (Sylvia Mathews Burwell) proposes to add SIRVA for all tetanus toxoid-containing vaccines that are administered intramuscularly through percutaneous injection into the upper arm.. more individuals receiving immunizations may be contributing to…rise in patient claims. SIRVA is the first condition compensated by the government that relates to vaccine technique instead of the substance within the vaccine…

Declaring they had "potentially lifesaving information," federal health officials said on Friday that they were ending a major study more than a year early because it has already conclusively answered a question cardiologists have puzzled over for decades: How low should blood pressure go? The answer: way lower than the current guidelines… The study found that patients who were assigned to reach a systolic blood pressure goal below 120 — far lower than current guidelines of 140, or 150 for people over 60 — had their risk of heart attacks, heart failure and strokes reduced by a third and their risk of death reduced by nearly a quarter.

The kerfuffle over Kim Kardashian's drug-promoting Instagram selfie is nothing new: As long as the agency has existed, it's had to figure out how to regulate drug advertisements in new forms of communication technology…The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role.

Food and Drug Administration is working to develop regulatory systems for diagnostics using next generation sequencing technologies…will cover "analytic performance evaluation standards" and "challenges in clinical validation of NGS tests."...We aim to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person's medical condition while continuing to foster innovation so that people who have access to the best available results generated by the most cutting-edge medical technologies."