Subject: POLITICO Pulse, presented by PhRMA: What's next from CMS: More help for doctors? — What's next for e-cig backers
From: POLITICO Pulse <[email-masked]>
To: <[email-masked]>
Date: Fri, 6 May 2016 08:02:53 -0600

By Dan Diamond | 05/06/2016 10:00 AM EDT

Millennials have killed America's 20-year running boom, and critics say that media coverage of a medical error study is error-ridden. But first: The head of CMS hints that the agency will roll out new initiatives to support doctors.

WHAT'S NEXT FROM CMS: MORE HELP FOR PHYSICIANS - That's what CMS acting administrator Andy Slavitt teased in a fireside chat Thursday in Baltimore.

Slavitt said that three core principles - that CMS needs to simplify physicians' practice, offer more flexibility and pay better for primary care - are shaping new rules and programs, like the MACRA law and comprehensive primary care (CPC+) demonstration. And those three beliefs will find their way into "other things this summer" too, he hinted.

They're also the "core elements" to ensure that small primary care practices remain independent, Slavitt said on Twitter, responding to Farzad Mostashari's assertion on POLITICO's "Pulse Check" podcast that Medicare is inadvertently pressuring the independent physician model.

WHAT'S NEXT FOR E-CIG BACKERS: HOPING FOR HELP FROM THE SENATE - Under Thursday's rule, e-cigarette companies must file an application with the FDA within two years to prove that they don't present any new public health risks. That's expected to prove costly and could thin the industry, Pro's Brett Norman points out. (More on that below.)

Vaping companies have allies in the House - who have pushed an amendment to exempt e-cigarettes already on the market from FDA's review - but any hopes that the Senate may join that effort might be built on fumes. The Senate has shown little interest to date in interfering with FDA oversight of vaping.

'Big Tobacco is getting just what it wanted.' That's according to law professor Jonathan Adler, who writes in the Washington Post's "Volokh Conspiracy" blog that the regulation will force many vaping companies out of the market.

"Even if smaller manufacturers can satisfy the relevant regulatory deadlines, the rules will increase the cost of e-cigs, limiting their cost advantage vis-a-vis traditional cigarettes and inhibit continued product innovation," Adler said, arguing it may turn out to be harmful for public health.

Read the post: http://go.politicoemail.com/?qs=2e8ad9e505130320232f844d72f78237deaf07cc188be263e662ef20287978ac 

Cost of compliance
FDA tobacco chief Mitch Zeller estimates the cost of application at "several hundred thousand dollars," though some e-cig advocates said that's a low-ball figure and many smaller players couldn't afford it in any case.

CIGARS MAY BE ANOTHER MATTER? - A bill in the Senate that would carve out premium cigars from the new FDA regulatory regime has 20 co-sponsors, including Sen. Jerry Moran, who chairs the FDA-Agriculture appropriations subcommittee. The list of co-sponsors: http://go.politicoemail.com/?qs=2e8ad9e5051303206c068fa20590fc77674a03915e6e2d46d253ee87cfa86aad

THANK GOODNESS IT'S FRIDAY PULSE - Where you're likely to spend more time on Facebook than doing anything else for fun. Tips and pokes to [email-masked] or @ddiamond on Twitter.

With help from Brett Norman (@BrettNorman)

POLITICO EVENT - COCKTAILS AND CONVERSATION. Health care and technology leaders discuss the cost of keeping our data safe at "Outside, In: Unhealthy Hacking: Medical Privacy in the Age of Cyber Attacks. Right after Health Datapalooza. Tuesday, May 10 - Doors at 5:15pm; District Architecture Center - 421 7th St. NW. RSVP: http://go.politicoemail.com/?qs=2e8ad9e5051303206d23d20611489950c0821d50a2e49b7767bb24c319b516c9

AMONG OUR PANELISTS - Brookings researcher Niam Yaraghi who this week released a provocative report arguing that the "alarming" overnight growth of electronic health records - thanks to the federal meaningful use program - meant that hospitals probably weren't ready with the necessary safeguards. And it costs $363 per record to fix a health care data breach, the highest of all industries, Yaraghi writes. Read his report:http://brook.gs/1QTszpv

THE ERROR IN MEDICAL ERROR COVERAGE - A much-buzzed about BMJ study that suggested 250,000 Americans die per year from medical errors relied on a "sensational and possibly inflated figure," watchdog Gary Schwitzer warns: http://go.politicoemail.com/?qs=2e8ad9e5051303208d0ddde760258ff47ee2af31cbae3c31eb2b11baacf76e35 

 - 'Advocacy masquerading as science: Medical Errors Edition.' That's Harvard economist Amitabh Chandra's assessment of the new study, which he thinks relies on made-up numbers.

ICYMI: WHERE INSURERS STAND ON OBAMACARE - With more earnings reports this week, here's PULSE's quick recap of where some of the nation's biggest insurers stand on the Obamacare exchanges.

Anthem: In 14 states now and may expand
Cigna: In seven states and expects to expand
Humana: In 15 states and pulling out of five-plus states
UnitedHealth: In 34 states now and pulling out of 26-plus states

- How to read insurers' rate requests. A new brief from Kaiser Family Foundation's Gary Claxton and Larry Levitt says that several core questions can help explain the rates that payers are asking for - and guide whether regulators will grant those requests, too.

Those questions include

1) Are current premiums adequate?
2) How will enrollment change in 2017?
3) What's the estimated increase in prices and services?
4) Are there significant changes in policy design or network?
5) Are there notable changes in law or regulation?
6) What's the state of competition in the market?

Read the brief: http://go.politicoemail.com/?qs=2e8ad9e50513032048591cdacc45b2eb41d124822af695a7fc37cc5de59de021 

** A message from PhRMA: Running. Spending time with family. These are activities Matt is able to do nearly 7 years after his non-small cell lung cancer diagnosis. This is possible thanks to new targeted therapies developed by America's biopharmaceutical research companies. Learn more about Matt's story here. **

NEW PAYMENT PILOTS MIGHT NOT FIT TOGETHER SO SEAMLESSLY - Medicare's slew of pilot programs are starting to bump into each other, with models like ACOs and bundled payments beginning to overlap and set up potential conflicts for participants, Brandeis health care fellow Robert Mechanic argues in NEJM.

"Until now, CMS's strategy of developing and testing payment models that could appeal to organizations at varying stages of readiness has been effective," Mechanic writes. "But reforms are reaching a scale at which distortions generated by overlapping models could create real problems."

Read the post: http://go.politicoemail.com/?qs=2e8ad9e5051303206771d865710c3af257f47a9edc12d5e960b17a55f1757281 

 - Are Medicare's payment schema approaching 'Big Short' levels of complexity? "Is there a way to bet against the whole system?" Yale Med assistant professor David Rosenthal griped to PULSE. "I don't think anyone really can possibly understand it - even the experts."

CDC: WHERE AMERICANS HAVE THE HARDEST TIME ACCESSING CARE - Overall, 17.3 percent of American adults between ages 18 and 64 didn't have a usual place for medical care in 2014, according to a new CDC report. However, researchers flagged wide variation between the states.

Where residents were least likely to have access: Western and Southwestern states
. Nevada: 26.7 percent of adults didn't have a usual place for care
. Idaho: 26.6 percent
. Texas: 25.4 percent

Where residents were mostly like to have access: Small Northeastern states
. Vermont: 2.8 percent of adults didn't have a usual place for care
. Delaware: 6.8 percent
. Massachusetts: 7.5 percent

VALEANT: WE'RE LAUNCHING A PRICING COMMITTEE - The troubled pharmaceutical company said its new internal committee of scientists, doctors and other employees is designed to avoid "mistakes of the past" that led to price-gouging and congressional scrutiny.

"This new committee will take a disciplined approach to reviewing the company's pricing of drugs, and will consider the impact on patients, doctors, and our health care industry partners," CEO Joseph Papa said in a statement. "Valeant's number one priority is ensuring patients can access the medicines they need."

- Drugs slated for review: Nitropress, Isuprel, Cuprimine and Syprine

ICYMI: WHAT WE'VE DISCUSSED ON THE PULSE CHECK PODCAST - It's been named a "Noteworthy" podcast by iTunes and been buzzed about on social media. Now catch up on the first two episodes of our brand-new podcast.

. Andy Slavitt on how CMS will win back doctors' hearts and minds. Listen: http://go.politicoemail.com/?qs=2e8ad9e505130320b07891ffb8334520f7963734af07de5c012feb329800579e
. Farzad Mostashari on how government really works. Listen: http://go.politicoemail.com/?qs=2e8ad9e505130320f2863a38e009a94b33bbe22466e5c748fe60fafba1705104

Subscribe to PULSE CHECK on iTunes.

THE STORY OF THE WEEK ... was a tight battle, and several people wrote in to suggest Gina Kolata's fascinating analysis of whether "The Biggest Loser" reality show actually helped contestants lose weight, and what it ultimately revealed about dieting.

However, the Los Angeles Times's investigation of Oxycontin - and the revelation that the drug's effectiveness wasn't all that it's cracked up to be, laying the groundwork for opioid addiction - got even more endorsements. Read the story: http://go.politicoemail.com/?qs=2e8ad9e505130320e2624a9ef1bb8cd5d6b8dfc48ad1027475d67b050a89482e 

 - A loud dissenter: Purdue Pharma pushes back on the Times' investigation, going point-by-point to dispute whether Oxycontin is less effective than advertised and if the company misled doctors and regulators.

"The LAT's claims have not only been publicly voiced, they've been directly rejected by regulatory authorities," Purdue Pharma writes.

NOT THE VIDEO OF THE WEEK - Siemens this week rebranded its health care business as "Healthineers," a relatively harmless term intended to evoke its spirt as a pioneering workplace, according to a statement.

Less innocuous: This "Healthineers" song and dance at a mandatory company event.

"Can confirm - this killed all productivity at our newly-christened Healthineers office today," a commenter wrote on Reddit. "This is going to be immortalized forever in the annals of horrible marketing mistakes."

THE RUNNING BOOM IS OVER - And millennials killed it, the Wall Street Journal asserts. (Millennials don't care about the competitive element of finishing races, for one thing.) http://go.politicoemail.com/?qs=2e8ad9e505130320752fdf34142557d7a6b0abd73375c0a75ff51d674890733c

POLITICO Pro Health Care Report: Reaching the Tipping Point: Health Care Delivery Reform: A conversation about regional variation in health care delivery system reform. How are different parts of the country responding to the push for value-based payment in the public and private sectors? Why do delivery and payment reforms take root in some markets but not others? Thursday, May 19 - Doors at 8:00 a.m.; W Hotel - 515 15th St NW. RSVP: http://go.politicoemail.com/?qs=2e8ad9e50513032079828c4c5ffeae793475bc34652ea5854554cc82684740a1

WHAT WE'RE READING

Should opioid training be mandatory for doctors? The New York Times convenes a "Room for Debate" to discuss: http://go.politicoemail.com/?qs=2e8ad9e5051303206e1a4430567bad04e4e10d806b85d13c64f68e6fa9e8b054

Vox's Johnny Harris tried to figure out how much it would cost for his wife to give birth. He failed, but it made for an entertaining video: http://go.politicoemail.com/?qs=2e8ad9e5051303201311af453f64c8b584d1aaa81a50b02a54b0cc4b48628de0

Massachusetts hospitals are negotiating with health care unions, trying to stave off a ballot measure that would change how they get paid, Priyanka Dayal McCluskey reports: http://go.politicoemail.com/?qs=2e8ad9e505130320328646ff9863b9f3e22a8ed435ecf74dec16ac24da2ecb56

Providers are investing big dollars in genomics, hoping that tests and biomarkers will help them predict who will stay healthy, Modern Healthcare's Beth Kutscher reports: http://go.politicoemail.com/?qs=2e8ad9e50513032027cce6f2f6da261f36731f951dc5fd1609d2ce6375d14ee5

Aaron Carroll's popular "Healthcare Triage" video series is tackling opioids this month, and here's an interesting primer on their ancient origin and their modern-day misuse. http://go.politicoemail.com/?qs=2e8ad9e5051303207d0c3f259581f1922e2b527fe42c60d844ff48461f07bbde

** A message from PhRMA: When Matt was diagnosed with advanced non-small cell lung cancer, he was given little chance of living 5 more years. Today, nearly 7 years later, Matt has defied his diagnosis, thanks to new targeted therapies developed by America's biopharmaceutical research companies. With more than 800 medicines in development for cancer, Matt and his family have the courage to keep fighting. Watch Matt's story here. **

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