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BioWorld - Wednesday, June 10, 2026
Home » Topics » Regulatory » Medicare

Medicare
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Latest telehealth bill would dismantle some geographic restrictions

Nov. 11, 2019
By Mark McCarty
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
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OIG says it may exclude devices from value-based arrangements

Oct. 10, 2019
By Mark McCarty
Despite a substantial build-up of expectations, the U.S. federal government has excluded device makers from a proposal to provide safe harbors under the anti-kickback statutes for value-based arrangements between providers and medical device makers. The news comes as a blow to device makers, who have argued for some time that value-based arrangements between industry and hospitals could save the taxpayer millions each year in Medicare spending, but the draft rule made note of concern that such arrangements might reduce competition among device makers.
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Draft proposal shows how HHS price negotiations could take shape

Sep. 11, 2019
By Mari Serebrov
Whether it's mere political posturing or a genuine prescription to control U.S. drug prices, a Democratic plan taking shape in the House provides an idea of what direct government negotiation might look like.
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Congress pushes ahead with Rx pricing bills as administration efforts founder

July 12, 2019
By Mari Serebrov
Faced with a tradeoff between low Medicare premiums that benefit all beneficiaries and lower out-of-pocket costs that benefit the sickest beneficiaries, the Trump administration chose lower premiums, sinking a proposed rule that would have pulled drug rebates from the safe antikickback harbor.
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Ignoring the science for a bigger box of crayons

March 8, 2016
By Mari Serebrov
Once upon a time in the days before enlightenment, we tried to use science to develop our drugs. Believe it or not, researchers actually had to come up with a hypothesis of how a drug might work, what disease it might tackle and who it might work for – before testing it in a crayon box of humans. In the early days, the focus was on drugs that worked for the average patient. In their rush to develop these drugs, sponsors were exclusive, almost elitist – some would say even discriminatory – in the patients they allowed in their clinical...
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Patient engagement as important as the data

Feb. 13, 2015
By Mari Serebrov
The thought of having unfettered access to all the medical and genomic data of a million Americans had researchers gathered at the National Institutes of Health’s first workshop on precision medicine licking their lips. Almost giddy with excitement, they contemplated the endless opportunities for “really big audacious research” that could lead to a man-on-the moon moment in unlocking the mysteries of life and disease. As a patient recently diagnosed with two forms of cancer – a type of breast cancer known only for what it isn’t and an indolent lymphoma for which there is no cure – I shared their...
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Spittin’ Image: Or, How I Am Probably Going to Die

Aug. 9, 2013
By Randy Osborne
“Once you obtain your genetic information, the knowledge is irrevocable,” warn the service terms at saliva-testing firm 23andMe.com. The news wasn’t so bad, except for Alzheimer’s. Also, I’m sort of related to Stephen Colbert. Of course, 23andMe, of Mountain View, Calif., can’t predict your medical future with certainty, but, using a saliva sample, does uncover a wealth of personalized data on predisposal to diseases – more than 240 health conditions and more than 40 inherited illnesses – along with likely drug responses and ancestry details that go back thousands of years. Here’s the process: You sign up online and pay...
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The implications and future of TAVR

June 24, 2012
By Mark McCarty
The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching. One: Coverage does not equal adequate reimbursement David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals. Cohen said the Medicare...
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Unhappiness of physicians is reflected in some startling numbers in career-recommendation survey

March 19, 2012
By Jim Stommen
As I read through one particular healthcare-related news item recently, the lyrics to the old “If you’re happy and you know it” song just plain took over my subconscious thinking. You know the one I’m talking about: “If you’re happy and you know it, then your face will surely show it.” It may not come as any great surprise that smiles aren’t adorning the faces of too many doctors these days, what with Medicare payment cuts, the looming impact of healthcare reform, skyrocketing malpractice premiums and other lesser complaints and concerns. But all that notwithstanding, it was just short of...
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Sinners, Repent? No. Scientists, Relent!

March 12, 2012
By Anette Breindl
Reading last weekend’s Wall Street Journal review of “The Forever Fix: Gene Therapy and the Boy Who Saved It” I was struck by an anecdote. It’s about an interview the reviewer did with a scientist who works in the field of neuroprostheses, and that scientist’s refusal to talk about the possible practical applications of his work, because, he said, “false hope is a sinful thing.” Really? To me, it seems like an inevitable part of hope is that it might be false. To illustrate, I don’t hope that my neighbors will be nice to me, because it’s a sure thing....
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