Capsule: Gene Editing, Safety Sticklers & an Opioid Overhaul

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By Jacquie Lee

Welcome to Capsule—your weekly dose of health-care news, where we give you a recap of this week’s highs and lows for key players in the health-care industry. You can expect us every Friday morning as a bookend for your week.

Aren’t you relieved to be reading something that doesn’t have to do with the G-20 summit kicking off today? The meeting is sure to stir the already bubbling pot of global chaos. I’m personally holding out for an arm wrestling match between Donald Trump and Chinese leader Xi Jinping. But the health-care space was embroiled in drama of its own this week. Let’s take a look.

Here’s who ended the week on a high note:

Safety Sticklers
  • The medical device field got a safety face lift from the Food and Drug Administration this week, Polina Noskova from Bloomberg News reports. The safety upgrade followed a damning report by the International Consortium of Investigative Journalists that found tens of thousands of deaths and millions of injuries linked to medical devices that were reported in the U.S. since 2008.
  • A massive regulatory revamp means device makers should expect growing pains, though, Ayanna Alexander reports. Especially when it comes to compliance confusion and increased research expenses, industry attorneys say.
  • The Advanced Medical Technology Association, the leading medical device trade association, said it supports the changes, but it anticipates other trade associations will push back. “I see companies speaking through trade associations and mainly saying that this is expensive for us,” AdvaMed’s CEO Scott Whitaker said.
Docs in Michigan
  • Doctors who cut back on the amount of opioids they prescribe their patients for certain surgeries are set up to get a windfall of cash thanks to Blue Cross Blue Shield of Michigan’s new payment system.
  • In pre-operative consultations, participating doctors walk patients through ways to reduce pain without using opioids. When doctors do pull out their prescription pads, they prescribe the bare minimum of pills, ranging from four to 10, depending on the surgery. In exchange, doctors get paid 35 percent more for those surgeries.
  • The new system adheres to a growing philosophy within health-care circles that reimbursement models should shift to reward quality, not quantity. Insurers, regulators, doctors, and activists alike have all tried to put their own spin on how to combat the opioid epidemic. This plan is unique in its simplicity and potential payback for participants.
  • There’s room for fraud, though, and it’s not clear how patients with chronic pain will react to lower doses.
CVS
  • CVS closed its $70 billion deal to buy health insurer Aetna Inc. this week, ending months of reviews by state and federal regulators, Drew Armstrong and Robert Langreth from Bloomberg News write.
  • The companies announced the takeover almost a year ago, promising to create an integrated health-care company whose pharmacy locations could be hubs for medical services while better managing patients.
  • The goals of the deal—better-managed care, new points of access to the medical system, healthier communities—are extremely ambitious. Now the companies have to prove they can actually achieve them in what’s likely to be an extremely complex merger.

It was a bleak week for others. Here’s whose Thursday closed on a downswing:

He Jiankui
  • If that name is unfamiliar, let me catch you up. He’s the U.S.-educated scientist based in China who used CRISPR, a powerful gene-editing tool, to make twin girls resistant to HIV, Bloomberg News reports.
  • He Jiankui faced international backlash throughout the week and his work sparked a global conversation about the future of gene editing and the ethics that surround it. Francis S. Collins, director of the National Institutes of Health, told Jeannie Baumann in an exclusive interview that He Jiankui’s actions could damage the entire field of gene editing.
  • Consequently, the NIH director called for a worldwide clampdown on gene editing of human embryos, Baumann writes.
  • All this controversy has highlighted a potential problem moving forward—that U.S. agencies lack the regulatory teeth for overseas gene editing. They can’t even punish a U.S.-based scientist who participated in He Jiankui’s work, Baumann reports.
Part D Access Advocates
  • Certain advocacy groups are already lashing out about a recent move to lower drug costs that allows Medicare Part D plans to not cover certain drugs if their prices spike, Mindy Yochelson reports. Insurers have to cover medicines in six “protected classes” of drugs, but the federal Medicare agency proposed a rule change Nov. 26 that would ease that requirement.
  • Gaining support for the proposed change is important because the agency may not finalize it if there’s strong opposition, Yochelson notes. That happened in 2014 when the Obama administration tried to impose similar restrictions around these protected drugs.
  • Amgen, Regeneron Pharmaceuticals, and Roche Holding might have the most to lose if the change is finalized, Cristin Flanagan of Bloomberg News reports.
  • Here’s how it works: Some drugs could be kicked out by insurers if, for example, their manufacturers raise the price by more than the consumer price index over about a year, Anna Edney from Bloomberg News writes. The proposal could save $692 million over a decade.
Dems Backing Medicare for All
  • Medicare for All has become a buzzword (or phrase) in health-care circles, but Shira Stein did some data digging that showed backing the progressive plan wasn’t too successful in competitive midterm races.
  • Medicare for All generally means single-payer health insurance for all Americans. Sen. Bernie Sanders (I-Vt.) sponsors a specific bill that would effectively replace all private health insurance with Medicare, which would be overhauled to cover all Americans at no cost.
  • While the “Medicare for All” battle cry caught fire with progressive voters in safely Democratic districts, only 3 percent of Democrats who ousted Republicans in competitive districts supported universal, single-payer health care, Stein writes. And if you’re a data nerd, feel free to look at the exact numbers here.

Thanks for joining us this week and have a great weekend. I’m all ears when it comes to your two cents, tips, critiques, or coordinating exclusive interviews. Send them my way at jlee1@bloomberglaw.com.

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