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Soul-crushing regulations: How bureaucrats are chasing smart young entrepreneurs out of HIT

At the House Energy and Commerce Committee’s second roundtable on digital health, Jonathan Bush spoke up for the people who were not in the room. He and several of 10 panelists explained that the culture of “wanton, random, soul-crushing regulation” was scaring many entrepreneurs and millions of VC dollars away from healthcare. He had two […]


At the House Energy and Commerce Committee’s second roundtable on digital health, Jonathan Bush spoke up for the people who were not in the room. He and several of 10 panelists explained that the culture of “wanton, random, soul-crushing regulation” was scaring many entrepreneurs and millions of VC dollars away from healthcare.

He had two asks of the committee during the hearing. One was to change enough laws to fix the business model of healthcare.

“You guys have made things that work in every other industry illegal in healthcare,” he said. “You can be drunk and in the wrong country and you can get your bank balance reconciled because the bank that needed the info can pay the other bank $3 to get it. If that happened between a doc and hospital, it’s prison time for that crime of supply-chain partnership.”

His second ask was about the incredibly discouraging effect of the reversals CMS has made lately around the deadlines for new rules. He had two specific examples.

“We put in 200,000 hours to make sure that every one of our 52,000 docs would be ICD-10 compliant, and on April Fools Day we got a letter that said, ‘Nope just kidding,'” he said. “So we’re a public company and we’re annoyed, but those kids! They had worked weekends and had pizza parties, and for nothing.”

He said the same thing happened when athenahealth got permission from OIG to pay for exchanges of healthcare data between doctors.

“We spent three years repricing our EMR so doctors could be paid by the order and then one year later, after you said yes, you said, ‘No, you can’t.'”

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Bush gave Anne Wojcicki, CEO & Co-Founder of 23andMe and another panelist, credit for slogging through battles with the FDA.

“What I’m thinking about is all the entrepreneurs who will not do it,” he said. “These people here today are a small part of the potential energy in healthcare. It is the disruptors that you need to let in.”