Mobile Device Management & MetTel Wireless Backup Deliver Security and Business Continuity

written by Journal of Telecommunications System and Management

New “Sunshine Provisions” in the Patient Protection and Affordable Health Care Act add federal requirements to a variety of obligations under state laws that regulate drug and device manufacturers’ marketing to healthcare providers. The Sunshine Act, one of 27 acts included in the Affordable Care Act’s comprehensive health care legislation, was signed into law by President Obama in early 2010 and requires all pharmaceutical and medical device companies to track and report all financial transactions, “payments or transfers of value,” greater than $10 to any physician or teaching hospital. This includes everything from modest meals, notepads, travel expenses, and speaking fees to consulting fees, research payments, and gifts of stock made to a health care provider or academic teaching institution.

On April 4, 2012 Senators Grassley and Kohl sent their second letter to Marilyn Tavenner, Acting Administrator for the Centers for Medicare and Medicaid Services (CMS), indicating their continued disappointment that CMS missed the statutory deadline for implementing the Sunshine Act by October 1, 2011. In their letter, the Senators strongly request that CMS promulgate the final rule by June 2012, with a strong focus on five essential elements of the law. CMS responded to the letter by giving industry a brief reprieve by delaying the aggregation and tracking of data until at least January 1, 2013. The reader should note that CMS has yet to release the final rules to implement the legislation along with the definitive reporting due date.

The constitutionality of the Affordable Care Act is currently under review by the US Supreme Court as it relates to the ACA’s “individual mandate” and Medicaid expansion. The Sunshine Act’s constitutionality was not questioned during the recent Supreme Court arguments, but the Sunshine Act would be vulnerable if the Court struck down the entire ACA.

The Critical Components Of The Transparency Ecosystem

Two critical and essential components of the “Health Care Transparency Ecosystem” must be addressed now if industry is going to be ready to aggregate and track data by January 1, 2013, and deal with physicians who want to review data prior to public disclosure: (1) An easy-to-use reporting system that provides physicians and teaching hospitals with the opportunity to proactively review, dispute and correct inaccurate data prior to submission to CMS; and (2) physician outreach and education, as currently 47 percent of US-based physicians and other covered recipients are not aware of the Sunshine Act.

Analyzing the comments on the proposed rule. The call for comments on the proposed regulations for the Sunshine Act ended on February 17, 2012 with over 300 comments posted online from private citizens, individual physicians, academic organizations, medical societies, the American Medical Association and industry support groups. My company, MMIS, reviewed and analyzed the comments and identified interesting trends and opinions. The overarching revelation was the fact that only a few individual physicians stated that the act should be repealed.

Basically, every organization and individual that submitted comments accepted that fact that health care transparency is inevitable and right around the corner. The main issues up for discussion and interpretation revolve around the level of detail of financial data to be reported; the date for the partial collection and submission of data in 2012; and the rules for proactive dissemination of reportable data to health care providers, including a notification, dispute, and resolution process for physicians to help provide context around the data for consumer interpretation. After all, wouldn’t you want to have the opportunity to review and dispute data about your financial relationships if they were to be published in an online database for the world to see?

The overall consumer sentiment is pro-transparency because transparency will reduce drug costs and because payments can influence doctors’ treatment decisions. The consumer response to the law and proposed rule is extremely favorable. For example, one consumer comment states: “I strongly support this proposed rule. As one of only two countries in the world where drug companies can advertise their products directly to the consumer, it is high time the influence of drug company money on physician’s decisions be reduced.”

Posting spend data online will encourage a proactive conversation and an ongoing discussion to share ideas via a Transparency Ecosystem. The Ecosystem will ultimately define the problem, the stakeholders and the solutions.

written by Ecosystem and Ecography

They live on your skin, up your nose, in your gut – enough bacteria, fungi and other microbes that collected together could weigh, amazingly, a few pounds.

Now scientists have mapped just which critters normally live in or on us and where, calculating that healthy people can share their bodies with more than 10,000 species of microbes.

Don’t say “eeew” just yet. Many of these organisms work to keep humans healthy, and results reported Wednesday from the government’s Human Microbiome Project define what’s normal in this mysterious netherworld.

One surprise: It turns out that nearly everybody harbors low levels of some harmful types of bacteria, pathogens that are known for causing specific infections. But when a person is healthy – like the 242 U.S. adults who volunteered to be tested for the project – those bugs simply quietly coexist with benign or helpful microbes, perhaps kept in check by them.

The next step is to explore what doctors really want to know: Why do the bad bugs harm some people and not others? What changes a person’s microbial zoo that puts them at risk for diseases ranging from infections to irritable bowel syndrome to psoriasis?

Already the findings are reshaping scientists’ views of how people stay healthy, or not.

“This is a whole new way of looking at human biology and human disease, and it’s awe-inspiring,” said Dr. Phillip Tarr of Washington University at St. Louis, one of the lead researchers in the $173 million project, funded by the National Institutes of Health.

“These bacteria are not passengers,” Tarr stressed. “They are metabolically active. As a community, we now have to reckon with them like we have to reckon with the ecosystem in a forest or a body of water.”

And like environmental ecosystems, your microbial makeup varies widely by body part. Your skin could be like a rainforest, your intestines teeming with different species like an ocean.

Scientists have long known that the human body coexists with trillions of individual germs, what they call the microbiome. Until now, they’ve mostly studied those that cause disease: You may recall health officials saying about a third of the population carries Staphylococcus aureus harmlessly in their noses or on their skin but can infect others.

But no one knew all the types of microbes that live in healthy people or where, and what they do.

Some 200 scientists from nearly 80 research institutions worked together for five years on this first-ever census to begin answering those questions by unraveling the DNA of these microbes, with some of the same methods used to decode human genetics.

The results were published Wednesday in a series of reports in the journals Nature and the Public Library of Science.

First, the researchers had to collect tissue samples from more than a dozen body sites.

Then they teased apart the bacterial DNA from the human DNA and started analyzing organisms with some daunting names: Lactobacillus crispatus, Streptococcus mitis, Corynebacterium accolens.

Our bodies are thought to be home to about 10 bacterial cells for every human cell, but they’re so small that together microbes make up about 1 percent to 3 percent of someone’s body mass, explained Dr. Eric Green, director of NIH’s National Human Genome Research Institute.

written by Ecosystem and Ecography