Subject: POLITICO Pulse, presented by Stop CMS Cuts: Part B demo: Over before it starts? — What you missed at Health Datapalooza — The FTC ... loses?
From: POLITICO Pulse <[email-masked]>
To: <[email-masked]>
Date: Tue, 10 May 2016 08:01:52 -0600

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

The FTC loses in court after a years-long winning streak against providers, and investigators pan CMS for its inability to stop Medicare Advantage overbilling. But first: The battle over Part B moves to a new stage.

PART B DEMO: OVER BEFORE IT STARTS? - Maybe so, if House Republicans get their way. The Energy and Commerce health subcommittee will hold a May 17 hearing on the embattled demonstration project, which CMS proposed as an effort to change how Medicare pays for drugs, according to a committee spokesperson.

The hearing will address "the Medicare drug experiment, including a review of Dr. [Larry] Bucshon's bill," a committee spokesperson told Pro's Jennifer Haberkorn and Sarah Karlin-Smith. The Buchson bill would end the demonstration project.

The demo, proposed just two months ago, has rapidly become the biggest target of health care lobbying.

WHAT INDUSTRY IS SAYING - Public comments on the demo were due to CMS on Monday, and more groups have come out with harsh reactions to the administration's proposal.

- GPhA's Christine Simmon: "We have serious concerns that the demonstration, as proposed, risks limiting the savings created through open market competition, particularly in the nascent biosimilars market. We strongly encourage the agency to carefully consider thoughtful changes to both phases of the demonstration in order to maintain robust competition, and a strong incentive to invest in affordable medicine, where possible." Read GphA's letter.

- AHIP's Matthew Eyles: "We strongly urge CMS to assess carefully the potential unintended impacts of its proposal, including the potential for cost shifting to other segments of the Medicare program as well as to Medicaid and the commercial market ... Both history and the experience of our members suggest that efforts to reduce pharmaceutical prices in one market segment can result in higher costs through manufacturers setting higher launch prices for new drugs and pursuing greater price increases on existing drugs." Read AHIP's letter.

PhRMA - which has called for CMS to withdraw the proposal - has a roundup of more critical reaction: http://go.politicoemail.com/?qs=f0f859ef2a41a41e2c3c6abc6ab8c80e26fcd977120a3d0a719e5205b0233c83 

WHAT THE ADMINISTRATION IS SAYING ABOUT THE DEMO - "Nothing in this proposal will prevent doctors or other clinicians from prescribing the treatment their patient needs," HHS spokesperson Ben Wakana told PULSE. "That's why the proposal enjoys support from a diverse set of voices - from AARP to the American Academy of Family Physicians to the former head of the Centers for Medicare and Medicaid Services under George W. Bush."

THIS IS TUESDAY PULSE - Where we're excited about Steph Curry's historic performance last night, but even more jazzed to see you at tonight's cocktails and conversation. Keep reading for details and send tips to [email-masked] or @ddiamond on Twitter in the meantime. 

With help from Brett Norman (@BrettNorman)

WHAT YOU MISSED AT HEALTH DATAPALOOZA - The annual health care innovation summit got underway on Monday, with David Bowie and Prince songs playing on the overhead speakers, and several top White House officials taking the podium to announce new initiatives in quick succession.

PULSE was there, and here were three key moments from Monday's session.

- Burwell kicks off contest to come up with a better medical bill. HHS's new "A Bill You Can Better Understand" contest is intended to crowd-source approaches and spotlight one of health care's most pernicious problems, HHS secretary Sylvia Mathews Burwell said. Winners get $5,000.

- DeSalvo announces $1.7 million in funding opportunities to improve data access. The awards will focus on improving "medication management, lab data exchange, [and] care coordination" standards, said National Coordinator for Health IT Karen DeSalvo.

- Biden exhorted crowd to break down 'data silos' in health care. The vice president - who said he's visited with hundreds of cancer leaders as part of the White House cancer moon shot effort - delivered his now-standard stump speech on the need to overcome "cancer politics" that have hampered clinical and research advances. 

Biden also blasted the NEJM's controversial editorial on "data parasites," saying that it's imperative for clinicians and researchers to be able to freely share information, including federally funded research that's currently hidden behind paywalls. "We have to make data available as soon as it's published," Biden added, his voice rising. "What the hell ... heck are we doing."

... Introduced by his son-in-law, surgeon and StartupHealth CMO Howard Krein, Biden kicked off his speech by warning he was "going to say something I shouldn't ... every Irish-Catholic dad looks forward to his daughter marrying a Jewish surgeon."

On tap for Tuesday's Datapalooza main stage
. Former White House tech czars Todd Park and Aneesh Chopra make quick appearances around noon.
. CMS acting administrator Andy Slavitt delivers a keynote address at 4:10 p.m.
. Sen. Sheldon Whitehouse speaks on the congressional perspective on health data at 5:00 p.m.

After Datapalooza tonight: Join POLITICO at 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. 
TONIGHT - Doors at 5:15pm; District Architecture Center - 421 7th St. NW. 
RSVP: http://go.politicoemail.com/?qs=f0f859ef2a41a41e732794be5c819505bdd8cb87b36b2c198567f39a803c697f Livestream: http://go.politicoemail.com/?qs=f0f859ef2a41a41e3116c3b9e3fedd1dcb066b005fd03d50a0dbc822f0debe61

Meanwhile, there was a health-news-apalooza on Monday for health wonks. Some of the major developments:

HILLARY CLINTON SUGGESTS YOUNGER AMERICANS COULD BUY INTO MEDICARE - The Democratic front-runner floated the idea at a campaign stop in Virginia on Monday. http://go.politicoemail.com/?qs=f0f859ef2a41a41e58bced1b0ad0de95587230d85c75aa8f141914b2f20fae61

ZIKA HAS NATION ON 'THRESHOLD OF A PUBLIC HEALTH EMERGENCY' - That's just part of a lengthy warning issued by the National Governors Association on Monday, which the White House touted as the latest reason for Congress to reach a deal on Zika funding. More for Pros.

THE FTC ... LOSES? - It's true: The regulators suffered a rare loss in court on Monday, when a federal judge declined to issue a preliminary injunction to block Penn State Hershey Medical Center and PinnacleHealth System's pending merger, Modern Healthcare's Lisa Schencker reports. 

 - Behind the judge's ruling: District Court Judge John Jones III said that FTC too narrowly defined the systems' service area and, more broadly, suggested the commission is too aggressively challenging mergers.

"We find it no small irony that the same federal government under which the FTC operates has created a climate that virtually compels institutions to seek alliances such as the hospitals intended here," Jones wrote.

- Why it matters: The FTC had already challenged the merger, but the commission normally drops its challenges when it loses at the preliminary junction stage, Schencker writes. However, industry-watchers told PULSE that they couldn't remember the commission losing a provider challenge since 2007, when FTC revamped its strategy to win a landmark case versus Evanston Northwestern. 

More here: http://go.politicoemail.com/?qs=f0f859ef2a41a41ecab191f8c62c2554d4399511855ec0f47781fe6beaf0a0db 

** A message from Stop CMS Cuts: Medicare has proposed a payment "model" that will take clinical decision making out of the hands of physicians by allowing the government to influence decisions for seniors. A patient's care should be determined by physicians in collaboration with patients, not government regulators. Stop Medicare's experiment on seniors. Visit StopCMSCuts.com. **

MEDICARE ADVANTAGE OVERBILLING IS RAMPANT, AND CMS ISN'T DOING ENOUGH - That's according to a new Government Accountability Office report, which says "fundamental improvements" are necessary to better regulate the private health plans that participate in the growing market.

According to GAO, the CMS audits intended to curb overbilling often dragged on for years without imposing significant financial penalties. (CMS responded that that the threat of audits has prompted health plans to voluntarily return hundreds of millions of dollars in overpayments.)

More context from the Center for Public Integrity: http://go.politicoemail.com/?qs=f0f859ef2a41a41e06af3b33e415f6a45935d40baeb27e425e5e88400a15c0ad 
Read the report: http://go.politicoemail.com/?qs=f0f859ef2a41a41e82d84b94b772eb7823c0dbcaa18f62eba9eddb1e2b14f07c 

The GAO on CMS's Medicare Advantage audits
. How much CMS has spent: $117 million
. How much CMS has recouped: $14 million

SENATE FINANCE: PHYSICIAN-OWNED DISTRIBUTORSHIPS NEED MORE SAFEGUARDS - The committee is out with a new report that concludes surgeons who participate in physician-owned distributorships, also known as PODs, tend to perform more surgeries. For instance, surgeons in PODs performed nearly twice as many spinal-fusion surgeries as non-POD surgeons, and experts have raised questions over whether the procedure is medically necessary - especially for seniors.

The report notes that doctors with a POD ownership stake may be motivated by the possibility of profit, given that PODs are intermediaries between device-makers and providers, and owners receive commissions on additional sales. http://go.politicoemail.com/?qs=f0f859ef2a41a41e5526d77c3cafe62c9e17c25c036ec86efb19bae708aea59b

RULES COMMITTEE MEETS ON OPIOID BILLS - More than 45 amendments were filed to the two opioid bills the Rules Committee will consider this afternoon. 

Of note, Democratic Rep. Joe Courtney offered his bill to provide $600 million emergency funding for the opioid crisis. Senate Democrats forced a vote on a companion while the Comprehensive Addiction and Recovery Act was on the floor to avoid a filibuster. House Democrats, however, have no such leverage. 

Peruse the amendments under the bills here: http://go.politicoemail.com/?qs=f0f859ef2a41a41e39b76be8701c28e41eb7a7f7def959198b7423047502607b

CMS WANTS MARKETPLACE LEADERS TO SHARE SECRETS AT INNOVATION FORUM - Some health plans have seen "particular success" in the new Obamacare exchanges, and CMS is inviting those standout plans and issuers to present their insights at a June 9 forum.

"One theme that's consistent is that success in the Marketplace requires a different approach to providing care than was required for success in the old individual market," writes Kevin Counihan, CEO of the Health Insurance Marketplace. Confirmed attendees include issuers like Aetna and several BCBS plans.

Read more: http://go.politicoemail.com/?qs=f0f859ef2a41a41e8a7c788508d972eb9d57b4dcaad58dc8824606dc81b95fa5

REVIEW FINDS MASS OPPOSITION FROM RESEARCH COMMUNITY TO KEY 'COMMON RULE' CHANGE - The federal government's proposed overhaul of the Common Rule governing human research "would be damaging to science, medicine and human health and would not improve participant safety and autonomy," according to a joint statement Monday by the Council on Government Relations and two other major university groups. The council analyzed the comments on changes proposed in September to the rule, which hasn't been updated since 1991. 

The review found that 95 percent of patients and members of the research community who commented opposed the government's proposal to make unidentified biospecimens such as tissue, blood and urine newly subject to informed consent requirements, Pro's Brett Norman reports. The change would reduce the specimens available for research and "dramatically increase the cost" of carrying it out, the joint statement said. The review covers comments on several key changes proposed, although opinion was more divided in other areas. 

Read the review here: http://go.politicoemail.com/?qs=f0f859ef2a41a41ed6547130921865a07d92f95895e041dfc13134138abdb7c1 
The proposed rule: http://go.politicoemail.com/?qs=f0f859ef2a41a41e47171d76f2b578d00073c120192e4e6e6a1ca225ad701d3c

MEDICARE'S VBP PROGRAM ISN'T LEADING TO IMPROVED MORTALITY - That's according to Harvard T.H. Chan School of Public Health researchers, who conclude that CMS's Hospital Value-Based Purchasing program didn't lead to improved 30-day mortality for acute myocardial infarction, heart failure and pneumonia. 

"Taken together, these findings call into question the effectiveness of the national hospital pay for performance program and whether it is having the desired effect on patient outcomes," the researchers write in BMJ: http://go.politicoemail.com/?qs=f0f859ef2a41a41edea6a93f97798b829fc9d858afe089b2b9ba56de9786ae5b

DETROIT'S PUBLIC HEALTH CHALLENGE, ACCORDING TO ABDUL EL-SAYED - The fresh-faced, 31-year-old director of Detroit's health department was in D.C. for a series of meetings on Monday and caught up with PULSE to discuss his city's efforts to improve public health.

A major challenge in Detroit? The city's poverty - it's linked with many local public health problems, and government programs have been decimated by fiscal struggles, including Detroit's recent bankruptcy. One striking stat: Detroit last fiscal year spent $1.50 per person on public health, El-Sayed said. (A city like Baltimore, on the other hand, spends more than $40 per person.) 

That's starting to change, El-Sayed said. The city's already invested $5 million in public health for the coming year - and the pot of money is still growing.

THE NEW YORK POST VS NEW YORK CITY - The tabloid paper attacked one of the city's public hospitals, Coney Island Hospital, as "hell hospital" filled with "horror" for patients, in a Sunday cover story. City officials immediately hit back, calling the story "full of holes and absurd claims." 

One reason why this is more than the usual tabloid dustup: Mayor Bill de Blasio is pushing a $1.8 billion transformation of the city's health system, Crain's Jonathan LaMantia notes, and the negotiation is at a politically sensitive point: http://go.politicoemail.com/?qs=f0f859ef2a41a41ec6467ad0516c1084c7e8db487532a2ab1e289d21c2060fa3 

IT'S 'ALS DAY' ON CAPITOL HILL - And patient groups and lawmakers are teaming up on a series of events intended to call attention to relevant legislation.

. At 10:30 a.m., Sen. Ron Johnson will hold a presser on his new bill to prevent federal agencies from interfering or blocking the implementation of state Right To Try laws.

. At 2:00 p.m., there's a briefing on Right To Try laws and Rep. Matt Salmon's own legislation in the Rayburn building.

ALSO ON THE HILL TODAY

. The Mercatus Center is hosting a 10:30 a.m. briefing in the Cannon Caucus Room on policy challenges and solutions for 2017 and beyond. Speakers will include Sen. John Barrasso and Rep. Brett Guthrie, among others. More.

. The Medicaid Health Plans of America are hitting the Hill for their spring legislative fly-in today. More.

WHAT WE'RE READING

Why are women under-represented among the authors of top medical studies? NPR's Lauren Silverman looks at a pernicious gender gap: http://go.politicoemail.com/?qs=f0f859ef2a41a41e5486c487fcc25fa394c5ae98a86fb32bb83097735eacbdc3

Farzad Mostashari, Bob Kocher and Mark McClellan are proposing a new track for CMS's Comprehensive Primary Care Plus program - what they're calling the CPC+ACO model: http://go.politicoemail.com/?qs=f0f859ef2a41a41eae6686201836db49bfa7c22d6bf0c5a38e45cf9175e16756

The 2007-2009 economic downturn left more than long-lasting financial damage behind, the Wall Street Journal reports. The Great Recession also left psychic and psychological scars for many Americans, too. http://go.politicoemail.com/?qs=f0f859ef2a41a41eb5aab38e059c1a25cacc912ba3cc62b4b7354a5ea14bf141

John Oliver dismantles the shoddy state of science coverage as only he can, and Lisa Aliferis sums it up: http://go.politicoemail.com/?qs=f0f859ef2a41a41e7739341c09369ff949ece093551c13c19553d22bc09788c3 

Before he died, Steve Jobs personally tasked Apple with fixing the U.S. health care system, and the Apple Watch was an extension of that mandate, a tech analyst writes in TIME. http://go.politicoemail.com/?qs=f0f859ef2a41a41e5277212c00ea9fc2b7059abe5ecd4ee4f9d23883849f8fa8

** A message from Stop CMS Cuts: Medicare has proposed a new payment "model" for Part B drugs that is really an experiment that will take clinical decision making out of the hands of physicians by allowing government bureaucrats to influence decisions for seniors. In a cookie-cutter approach, Medicare wants to sway treatment options based solely on cost and not on the patient's individual clinical needs. Rather than testing payment changes in a limited, controlled model, this is a mandatory, national experiment without patient safeguards and disclosures. Decisions about a patient's care should be made by physicians in collaboration with patients, not government regulators. 

Bipartisan lawmakers, patient advocates and providers agree: We must stop Medicare's experiment on seniors. Visit StopCMSCuts.com to learn more. **

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