April 26, 2018
So long to Meaningful Use

Congratulations to our colleagues at Healthcare Dive for having a short (and clear) exposition of the 1,800-plus page proposed rule for the hospital inpatient prospective payment system, Medicaid and Medicare EHR incentive programs, and sundry other matters that CMS published on Tuesday. 
Apparently CMS hasn't ruffled too many feathers with the rule. The American Hospital Association's reaction was largely favorable. 
As many have noted, the rule would retire the name of the much-maligned Meaningful Use program and replace with it Promoting Interoperability. 
Window dressing? Well, sure, any rebranding is partly that but there may also be some real bite here. Farzad Mostashari pointed to page 1475 and the possibility that interoperability would be made a requirement of participating in Medicaid and Medicare programs. 
The suicide-opioid overlap

Maria Oquendo and Nora Volkow have a perspective piece in this week's  New England Journal of Medicine (full text is available) exploring the "intermingled" epidemics of suicide and opioid use disorder. Drug overdoses accounted for 15% of the 45,000 suicides in the United States in 2016, they note, and the proportion of suicides attributed to opioid overdoses is increasing (4.3% in 2014), although is still relatively small. 
But Oquendo and Volkow make a case for those statistics not capturing the full story. "The distinction between unintentional and volitional deaths may be blurred among with people OUD [opioid use disorder], whose motivation to live might be eroded by addiction," they point out. It's a thoughtful piece and well worth the time.
But what's more serious than the opioid epidemic?

Obesity, according to David Blumenthal, MD, and Shanoor Seervai at the Commonwealth Fund.
In a blog post this week they wrote that obesity is "a grave public health threat, more serious than the opioid epidemic" because of all of its health (many of them deadly) consequences-stroke, diabetes, cancer (7% of cancer deaths, which works out to 40,000 deaths each year, can be attributed to excess body weight, say Blumenthal and Seervai). 
The blog post doesn't go deeply into policy prescriptions-it's just a blog post, after all-Blumenthal and Seervai do give a nod of approval to taxes on harmful foods such as the sugary drink taxes imposed by the cities of Philadelphia, Boulder, and Berkeley. 
The Amazon Watch: Might we see CEO soon? 

Dan Primack at Axios reported this week that the Amazon-Berkshire Hathaway-JPMorgan health partnership thingamajig will hire a CEO sometime in the next two months. 
Meanwhile, 25% of those who responded to a Venrock survey said that the companies don't have any idea what they are getting into. 
In a Bloomberg TV discussion this week, Bain partner Nirad Jain said the partnership's biggest asset is that the three companies have a total of a million employees, three quarters of them in this country. They are loyal and may be more willing than most to tolerate "experimentation" with how their health care is covered and delivered, said Jain.
Oncologists struggle with off-label cancer immunotherapy 

Unproven. And expensive. But perhaps the only thing left to try.
Gina Kolata of the  New York Times has a gripping story today about oncologists wrestling with the question of whether to offer patients off-label immunotherapy. 
Christopher Sweeney, MD, at Dana-Farber Cancer Institute in Boston is quoted as saying that he petitions insurance companies when the patient has a genetic market predicting a response. He may offer patients who don't have markers a chance to participate in a clinical trial.  And when there's no trial, "I basically say I don't have any approved therapies." 

"Here's the truth," Sweeney told Kolata. "Most patients don't benefit from these drugs."
Patient charities getting scrutiny 

The  Washington Post published a long-form piece yesterday about the patient charities that cover drug copayments and in some cases insurance premiums for people who need treatment with high-priced drugs. 
The gist: On the one hand, people get treatments they might not otherwise get and are protected from expensive prices-the financial toxicity that researchers and doctors have been talking about.
On the other hand, the charities shield the drug companies from pressure to lower their price.
The  Post reporter, Carolyn Y. Johnson, cites a Citi Research report that found that a $1 million donation to a patient charity can generate up to $21 million in drug sales for a pharmaceutical company. That report, which was published last May and so is getting a little dated, says that multiple government investigations into pharma donations to patient charities could affect future revenues of several high-priced drugs covered by Medicare Part D.
An essay posted on the Hastings Center Bioethics Forum about pain advocacy groups and their connections to pain medication manufacturers is also getting a lot of attention. The headline: "Fentanyl at Your Door: Who are Pain Groups Advocating For." 
And  from our ICYMI department 
Gottlieb on biosimilars: Relax, it's early

Who was the last FDA commissioner to have such a high profile? Maybe David Kessler.
In a Q&A published last week in  Regulatory Focus, an online publication of the Regulatory Affairs Professionals Society, Scott Gottlieb said "we're in the early innings of biosimilars" and compared the uptake and perception of biosimilars now to the generics in the mid-'80s. Eventually, of course, generics caught on in a big way.  
Gottlieb also told the  Focus's Zachary Brennan that agency officials are piloting a new document that will provide more information about drug reviews when a drug is approved. He said it will be coming out in the next six to 12 months.
Peter Wehrwein
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