Citing the First Amendment, the Fifth Amendment and the logic of fair play, Pfizer Inc. is taking on a Health and Human Services’ (HHS) antitrust policy that prohibits drug companies from helping Medicare beneficiaries with hefty copays.

Heartflow Inc., of Redwood City, Calif., is working on two Medicare administrative contractors (MACs) to cover its functional flow reserve algorithm for the coronary arteries, but Heartflow’s Heather Brown told BioWorld that said that the existing local coverage policies fall far short of the cost of the service, thus impeding beneficiary access.

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.

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.

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.

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.

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...

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...