Subject: POLITICO Pulse, presented by PhRMA: Out today: FDA's final tobacco rule? — House GOP subpoenas HHS — Q&A: Farzad Mostashari on MACRA, meaningful use and more
From: POLITICO Pulse <[email-masked]>
To: <[email-masked]>
Date: Thu, 5 May 2016 08:01:52 -0600

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

Hepatitis C deaths hit an all-time high, and Farzad Mostashari sits down for an interview with PULSE's new podcast. But first: A long-awaited FDA rule finally has its day.

OUT TODAY: FDA'S FINAL TOBACCO RULE - The agency this morning is announcing its long-delayed rule to regulate e-cigarettes and other tobacco products.

What's in the rule: FDA is extending its authority to regulate e-cigarettes, hookah and flavored cigars, among other measures. Under the final rule, FDA plans to ban the sale of these products to anyone under 18 years old.

What took so long : While the proposed rule was issued in April 2014, its finalization was delayed by an aggressive lobbying push to protect the rapidly-growing electronic cigarette market. The final rule had been parked at the Office of Management and Budget since October - about 20 months after it was first proposed.

Read the rule: http://go.politicoemail.com/?qs=8762c110ba3a5d0699220caf2e3d96b095e54a691ab152023328d79181f8772a

On tap this morning: HHS Sec. Sylvia Mathews Burwell and FDA commissioner Robert Califf are making a "major public health-related announcement" at 10:30.

YOU HAVE TO BE 21 TO SMOKE IN CALIFORNIA - That's according to a bill signed into law by Gov. Jerry Brown last night. California becomes the second state to raise its smoking age to 21, after Hawaii last year. More for Pros.

FARZAD MOSTASHARI ON MACRA, MAKING REFORM AND MORE - The former health IT czar-turned-startup CEO sat down with our "Pulse Check" podcast to discuss policymaking and payment reform, including his recent critique that Medicare's proposed physician payment rule is "financial suicide" for small physician practices.

"I regret [that], a little bit," Mostashari told POLITICO's podcast. "That was maybe a little bit too strong." But he does believe that MACRA in its current form penalizes small practices, and that the independent physician model is facing undue pressures. (Mostashari's company, Aledade, works with physicians to set up ACOs.)

- Accelerate the pace of reform? At the same time, Mostashari says that he's learned that regulators can be too cautious in their attempts to avoid rocking the industry.

"Maybe some people should go out of business," he told POLITICO, referring to the vendors that Mostashari considers laggards. But "that's not something you can really say" as a regulator, he added.

Listen to the podcast: http://go.politicoemail.com/?qs=8762c110ba3a5d061adc2bbe9dc47beb646bdfa2829c8ad5d7075fd42c5b21c4 
Subscribe on iTunes: http://go.politicoemail.com/?qs=8762c110ba3a5d06da6551156d82887ba99423e58ca761c3b22d0ac435051b00 

Tidbit we learned from the podcast
. On Mostashari's last day as National Coordinator for Health IT, he walked out the door and left his badge on his desk - because it was October 2013, the government was shut down, and there was no one around to give it to.

THIS IS THURSDAY PULSE - And this is the brand-new cover of TIME magazine, which has a package of stories on Zika virus this morning. Tips to [email-masked] or @ddiamond on Twitter.

With help from Jennifer Haberkorn (@JenHab) and Brett Norman (@BrettNorman)

HOUSE GOP SUBPOENAS HHS - Two House committees have subpoenaed the agency to turn over documents related to the cost-sharing reduction program, the central piece of the House's lawsuit against the Obama administration, Pro's Jennifer Haberkorn reports.

The House Ways and Means and Energy and Commerce committees subpoenaed HHS and OMB for all the documents relating to the development of the program. The committees say that HHS has stonewalled on their requests for information.

Congressional Republicans say that the administration has been illegally paying subsidies to insurance companies without an appropriation. The administration counters that the program was funded by the health law.

- HHS response: 'We're disappointed.' "Our Department has worked collaboratively with Congress to provide information regarding this program, including by responding to letters, providing documents, and making four senior officials available for interviews," spokesperson Ben Wakana said in a statement.

OUT: LAWYER WHO LED HOUSE OBAMACARE CHALLENGES - The top lawyer for the House of Representatives, General Counsel Kerry Kircher, is resigning after more than five years on the job, Kircher oversaw several high-stakes legal showdowns between the House and the Obama administration, including the still-pending lawsuit challenging provisions in the Affordable Care Act.

IN: HOUSE HEARING ON MACRA - Ways and Means Committee Health Subcommittee Chairman Pat Tiberi announced a hearing on the implementation of Medicare's physician payment law for next Wednesday, May 11. 

Expect to hear an airing of grievances about whether CMS's proposed rule is too hard on providers, but also some celebration; Ways and Means Chair Kevin Brady last week said he was "pleased" to see the proposed regulation, and many Republicans have applauded the law as a bipartisan accomplishment.

HOUSE DEMS PUSH EMERGENCY OPIOID FUNDING - More than 50 House Democrats are urging Speaker Paul Ryan to consider a proposal for $600 million in emergency funding as part of forthcoming legislation on the opioid epidemic. A similar proposal was defeated as an amendment to the Senate-passed CARA legislation and House Republicans have said they will address funding through the appropriations process - not a supplemental funding bill.

Read the Wednesday letter from Democrats: http://go.politicoemail.com/?qs=8762c110ba3a5d06693160e42bed74e861e0bcd85306bfad1f0ebf6fe5c2879f

** 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. **

OBAMA TO FLINT: 'I'VE GOT YOUR BACK' - The president's day-long visit to the city on Wednesday included stops with community members and a speech at a high school. HHS Secretary Sylvia Mathews Burwell and other federal officials accompanied him.

The high-level visit was framed around reassuring residents of the city still grappling with a toxic water crisis. "I want to hear directly from you about how this public health crisis has disrupted your lives, how it's made you angry, how it's made you worried," the president said in remarks.

- He stressed that residents will be OK. The president said that "lead is a serious issue" that can lead to long-term problems, but those public health problems can be averted with the proper diagnoses, resources and support.

"The point is that as long as kids are getting good health care, and folks are paying attention ... and they are in a community that is loving and nurturing and thriving, these kids will be fine," he added.

- He drank the water. Obama also twice sipped from a glass of Flint's filtered tap water, seeking to prove that it was potable.

The White House fact sheet on Flint funding and response: http://go.politicoemail.com/?qs=8762c110ba3a5d0612732b351a421f0f7b147ba1ff38bd79aa464c8a30bbdccc 

MISSOURI DEBATES PERSONHOOD - A female state representative in Missouri this week said that a child can be the "silver lining" of a rape. The comment, which was part of the debate over a personhood vote, stirred opposition among abortion rights supporters, Pro's Jennifer Haberkorn reports.

"It is not up to us to say 'no just because there was a rape, they cannot exist,'" Rep. Tila Hubrecht said. "Sometimes bad things happen - horrible things, but sometimes God can give us a silver lining through the birth of a child." 

The state house issued preliminary approval of the measure, which would allow voters to weigh in on whether a fetus should have constitutional rights under law. The measure needs final approve in the House before it could go to the state Senate. The St. Louis Post-Dispatch has more: http://go.politicoemail.com/?qs=8762c110ba3a5d06b51b25970936ca1dfa3bfdc655dbe3806fef849bd27eb8bf

URBAN INSTITUTE: HOW MOMS ARE FARING UNDER THE ACA - A new report finds that the uninsured rate for America's moms fell to 15.7 percent in 2014, a 3.8 percentage-point decline from the year before, thanks to Obamacare coverage expansion.

- Best Mother's Day present: Health coverage? Nearly 6 million moms were still uninsured as of 2014, researchers note. See the report: http://go.politicoemail.com/?qs=8762c110ba3a5d06efd0ce5d087ab9099cc8182a97f82e70750da9d7e8e29bc0 

HOSPITAL-BACKED VENTURE FUND CLOSES $220 MILLION ROUND - The Heritage Group announced this week that 15 companies are participating in its latest innovation fund, including major hospital networks like Intermountain Healthcare and Tenet Health and several industry players like Cerner. 

It's a sign of how providers are increasingly seeking to diversify, including by shaping the technologies changing health care - and potentially profiting from them, too. More from Modern Healthcare: http://go.politicoemail.com/?qs=8762c110ba3a5d063fd47ebd98ba0443f5dbbd5a000a3b21551df3ce79de47b9 

INVESTIGATORS ARE EYEING PRINCE AS POSSIBLE OVERDOSE DEATH - The Drug Enforcement Administration and the United States Attorney's Office have joined the investigation into the pop star's death, amid reports that he overdosed on opioids, according to a New York Times front-page story today: http://go.politicoemail.com/?qs=8762c110ba3a5d06b5d77814e91e6c437116b00f13db183dd82975eec38ee2b8

PATIENT ADVOCACY GROUPS TAKE ON COST OF PREMIUMS - A coalition of national patient advocacy organizations today are launching the Marketplace Access Project, an initiative intended to help individuals with chronic and severe illnesses afford their premiums. "The inability to afford your insurance premium should not be the new 'pre-existing condition' that impedes a patient's access to care," said Marcia Boyle, the CEO of the Immune Deficiency Foundation, one of the groups in the coalition.

HEPATITIS C DEATHS HIT ALL-TIME HIGH - That's according to new CDC data released on Wednesday, which found that hepatitis C killed nearly 20,000 Americans in 2014, more than any other infectious disease. CDC also flagged an alarming uptick in new cases of hepatitis C, mostly among young men with a history of using injectable drugs. 

See the release: http://go.politicoemail.com/?qs=8762c110ba3a5d06d17d717a71fc1eb22881e6b0dc1b805f0e751df69e65109d

Deaths associated with hepatitis C
2003: 11,051 deaths
2014: 19,659 deaths 

COST OF CONCUSSIONS TO COLLEGE? $712,000. That's the settlement that Bowling Green University agreed to pay to a former football player, who said he suffered concussions that cost him his scholarship and led to permanent brain injury.

POLITICO Event - Outside, In: Unhealthy Hacking: Medical Privacy in the Age of Cyber Attacks. Join POLITICO and health care and technology leaders for cocktails and conversation about the cost of keeping our data safe. Tuesday, May 10 - Doors at 5:15pm; District Architecture Center - 421 7th St. NW. RSVP: http://go.politicoemail.com/?qs=8762c110ba3a5d0673ae5aaeef935e2ef41a8d725eb7f2f3e7bbe4db15efd0e6 

WHAT WE'RE READING by Darius Tahir

A provocative proposal: Could the government use "eminent domain for drugs" to force drug makers to the negotiating table? http://go.politicoemail.com/?qs=8762c110ba3a5d0645e4ae23c0c26cfa9c7afb002b63d5bbf9b6a7527ee890c4

Researchers say bacteria could help control Zika's spread, Judy Stone writes at Forbes: http://go.politicoemail.com/?qs=8762c110ba3a5d06490cd1748af3b4a4abf2f71add959be71e80abe471cce6b8 

The hit new accessory for kids with American Girl dolls: A $24 diabetes care kit. http://go.politicoemail.com/?qs=8762c110ba3a5d068f4293671323225979b4f84490a80eb4d84f6b7b2910d356

Three insights on MACRA from the experts at Brookings: http://go.politicoemail.com/?qs=8762c110ba3a5d0602bf00547e588e66b327fa07cd847d9fd8e1bf2fe51bbfe5

What drove a man to perform a do-it-yourself fecal transplant - and how it turned out: http://go.politicoemail.com/?qs=8762c110ba3a5d06b176b8be441bcb0b3add6a7256a9e330b455d8e3d2e3fdce

** 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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