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What the New York Times Got Wrong about Medicare’s Innovation Center

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By Dan Diamond

Since CMS’s Center for Medicare and Medicaid Innovation launched three years ago, its staff have been frequently hailed for undertaking an ambitious research agenda.

But a New York Times story this week was eye-catching for a different reason: author Gina Kolata mostly assailed Medicare’s researchers for how they’re choosing to do that research.

“Experts say the center is now squandering a crucial opportunity,” Kolata wrote in a front-page article. “Many researchers and economists are disturbed that [CMMI] is not using randomized clinical trials, the rigorous method that is widely considered the gold standard in medical and social science research.”

But many researchers and economists that I talked to at this week’s Academy Health conference say that’s not the case at all. (And some were disturbed to learn that they were supposed to be disturbed.)

“RCTs are helpful in answering narrowly tailored questions,” Harvard’s Ashish Jha told me. “Something like—does aspirin reduce 30-day mortality rates for heart attack patients.”

“However, for many interventions, RCTs may be either not feasible or practical.”

“While RCTs may be the gold standard for testing some hypotheses, it is not necessarily the most effective or desirable model for testing all hypotheses,” agrees Piper Su, the Advisory Board’s vice president of health policy.

CMMI’s ambitious goals

On its surface, Kolata’s article is built around a reasonable conclusion: RCTs offer plenty of value in health care, and we’d benefit from more of them.

  • As Jha alludes to, think of a double-blinded pharmaceutical study where half the participants randomly get a new drug and the other half get a placebo; that’s an RCT.
  • The famous RAND study that found having health insurance changes patients’ behavior: An RCT.
  • The ongoing Oregon Health Insurance Experiment: Also, an RCT.

And it’s fair to examine how CMMI is pursuing its research, too.

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Why Didn’t the President Mention the Latest Good News on Health Costs?

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By Leah Binder

President Obama rarely shies away from an opportunity to tout successes in U.S. health care, but in last night’s State of the Union oddly omitted any mention of the new and optimistic report about U.S. health spending from actuaries at the Centers for Medicare and Medicaid Services (CMS).

The finding: from 2009 through 2012, health care spending in the U.S. grew at the slowest rate since the government started collecting this data in the 1960s.

The actuaries found that in 2012 spending “stabilized,” growing by 3.7 percent in 2012, and health care accounted for a slightly smaller percent of GDP than the prior year, 17.2 percent versus 17.3 percent in 2011.

Perhaps an actuarial report proclaiming stable growth doesn’t make for much of an applause line for a State of the Union speech. But for confessed policy wonks like me, it’s as good as a Hollywood blockbuster.

So get out your popcorn, here are five Hollywood moments in the report.

1. Ninja Combat

When the report came out in early January, the Obama administration quickly ascribed the good news to Obamacare. But, lo and behold, the actuaries wielded their slide rules like weapons.

They respectfully disagreed with their president, pointing out that few of the provisions in the health reform law were actually in place during the slow-growth years in question. The actuaries conclude that most of the cost stability results from the economic recovery process.

Given the silence in the State of the Union, they may have been given the last word on the subject.

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Some Predictions on How Medicare Will Release Physician Payment Data

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By CHARLES ORNSTEIN

The federal government’s announcement last week that it would begin releasing data on physician payments in the Medicare program seems to have ticked off both supporters and opponents of broader transparency in medicine.

For their part, doctor groups are worried that the information to be released by the Centers for Medicare and Medicaid Services will lack context the public needs to understand it.

“The unfettered release of raw data will result in inaccurate and misleading information,” AMA President Ardis Dee Hoven, MD, said in a statement to MedPage Today. “Because of this, the AMA strongly urges HHS to ensure that physician payment information is released only for efforts aimed at improving the quality of healthcare services and with appropriate safeguards.”

On the other hand, healthcare hacker Fred Trotter has raised concerns about CMS’ plan to evaluate requests for the data on a case-by-case basis. That isn’t much of a policy at all, he wrote, giving federal officials too much discretion about what to release.

So, how is this all going to shake out?

Three recent examples offer some clues.Continue reading…

A Little Advice for Karen DeSalvo

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By John Halamka, MD

Karen DeSalvo started as the new National Coordinator for Healthcare Information Technology on January 13, 2014.   After my brief discussion with her last week, I can already tell she’s a good listener, aware of the issues, and is passionate about using healthcare IT as a tool to improve population health.

She is a cheerleader for IT, not an informatics expert.  She’ll rely on others to help with the IT details, and that’s appropriate.

What advice would I give her, given the current state of healthcare IT stakeholders?

1.  Rethink the Certification Program – With a new National Coordinator, we have an opportunity to redesign certification. As I’ve written about previously some of the 2014 Certification test procedures have negatively impacted the healthcare IT industry by being overly prescriptive and by requiring functionality/workflows that are unlikely to be used in the real world.

One of the most negative aspects of 2014 certification is the concept of “certification only”. No actual clinical use or attestation is required but software must be engineered to incorporate standards/processes which are not yet mature.   An example is the “transmit” portion of the view/download/transmit patient/family engagement requirements.

There is not yet an ecosystem for patients to ‘transmit’ using CCDA and Direct, yet vendors are required to implement complex functionality that few will use. Another example is the use of QRDA I and QRDA III for quality reporting.

CMS cannot yet receive such files but EHRs must send them in order to be certified.   The result of this certification burden is a delay in 2014 certified product availability.

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A Little Advice for the Next National Coordinator

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By John Halamka, MD

Over the next few months, Jacob Reider will serve as the interim National Coordinator for Healthcare IT while the search continues for Farzad Mostashari’s permanent replacement.

What advice would I give to the next national coordinator?

David Blumenthal led ONC during a period of remarkable regulatory change and expanding budgets. He was the right person for the “regulatory era.”

Farzad Mostashari led ONC during a period of implementation when resources peaked, grants were spent, and the industry ran marathons every day to keep up with the pace of change. He was the right person for the “implementation era”

The next coordinator will preside over the “consolidate our gains” era. Grants largely run out in January 2014. Budgets are likely to shrink because of sequestration and the impact of fiscal pressures (when the Federal government starts operating again). Many regulatory deadlines converge in the next coordinator’s term.

The right person for this next phase must listen to stakeholder challenges, adjust timelines, polish existing regulations, ensure the combined burden of regulations from many agencies in HHS do not break the camel’s back, and keep Congress informed every step of the way. I did not include parting the Red Sea, so maybe there is a mere human who could do this.

What tools does the coordinator have in an era of shrinking budgets?

At present, Meaningful Use Stage 2, ICD-10, the Affordable Care Act, HIPAA Omnibus Rule, and numerous CMS imperatives have overlapping timelines, making it nearly impossible for provider organizations to maintain operations while complying with all the new requirements.

Can resources be expanded?

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Finally Some Good News on Readmission Rates

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By Ashish Jha, MD & Thomas Tsai, MD

Why readmission penalties are controversial

Penalizing hospitals for high readmission rates has been pretty controversial.  Critics of the program have argued that readmissions have little to do with what happens while the patient is in the hospital and are driven primarily by how sick or how poor the patient is.  Advocates of the readmissions program increasingly acknowledge that while readmissions may not reflect the quality of care that occurred within the hospital, someone should be accountable for what happens to patients after discharge, and hospitals are the logical choice.  While the controversy continues, there is little doubt that the metric is here to stay.  This October, the CMS Hospital Readmissions Reduction Program (HRRP) will increase its penalty on excess readmissions from 1% to 2% of total hospital reimbursement.

So far, CMS has focused on readmissions that occur after patients are discharged with one of three medical conditions—acute myocardial infarction, pneumonia, and congestive heart failure.  The data on the impact of the program are mixed:  while readmission rates appear to be dropping, the penalties seem to be targeted towards hospitals that care for some of the sickest patients (academic medical centers), poorest patients (safety-net hospitals) and for heart failure, some of the best hospitals (those with the lowest mortality rates).  No wonder the program has been controversial.

Why surgery may be different

In 2015, CMS extends the program to focus on surgical conditions, which provides an opportunity to think again about what readmissions measure, and what it might take to reduce preventable ones.  And if you think about it, surgery may be different.  Most patients who are admitted for Acute MI, CHF, and pneumonia are chronically ill and bounce in and out of the hospital, with any one hospitalization likely just an exacerbation of underlying chronic illness (especially true for pneumonia and heart failure).  Not so for surgery—at least not for the major surgeries.

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Replacing Farzad

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By Anonymous HIT Insider

In the wake of the National Coordinator’s announcement that he is departing, there has been a flurry of tweets, blog posts, impromptu online polls, and conjecture about the most likely successor.  To date, none of these conversations has resulted in a thoughtful assessment of the set of characteristics that would represent the ideal candidate, nor has there been any thorough review of the most likely candidates in the context of these attributes.  The need for a rapid transition to a successor is well understood by all – yet there has been no indication that the Obama administration is in a hurry.  Let’s hope that we can evolve them toward a greater sense of urgency. The fragility of ONC – and the importance of its health – can’t be overlooked.

Let’s consider some history:

The first two National Coordinators, David Brailer and Rob Kolodner, were appointed before ARRA.  The agency was small, focused largely on certification (through CCHIT), standards (through HITSP) and policy.  When ARRA arrived, David Blumenthal, a thoughtful, deliberate, policy-savvy internal medicine physician from Boston was brought in to lead the rapid expansion of health IT that was facilitated by the HITECH Act.

ONC expanded under Blumenthal from a team of ~ 30 people to a team of >100 in the two years that he was at the helm, and the agency published the 2011 certification criteria regulations, and collaborated with CMS to publish the regulations that defined stage 1 of the Meaningful Use incentive program.  The policy foundation was that the three-stage program – to be implemented over six years – would evolve the nation’s care delivery system by causing adoption of EHR technology (stage 1) and then exchange of clinical information electronically (stage 2) and finally improved clinical outcomes (stage 3).

Farzad Mostashari, who joined Blumenthal as the Deputy National Coordinator early in Dr Blumenthal’s tenure, was quickly named as Blumenthal’s successor when Blumenthal announced his resignation in the Spring of 2011.  Both Mostashari and Blumenthal pushed hard for Mostashari’s appointment – so that the consistency, focus and forward momentum of the organization could be maintained.

And so it was.  Under ARRA, adoption of EHRs has skyrocketed.  The CMS MU Stage 2 regulations and the ONC 2014 certification regulations were published, and the size of the agency has doubled to over 150 people.  Recognizing the need for experienced partners to assist him in leading a larger agency – and growing national reliance on health IT and an essential component of the care delivery ecosystem – Mostashari hired David Muntz as the “Principal Deputy” (essentially the COO of the agency), Jacob Reider as Chief Medical Officer (leading a team of clinicians focused on quality and safety) and Judy Murphy as the Deputy National Coordinator for Programs and Policy (adding internal coordination support for ONC programs).

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Enabling the Health Care Locavore

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By Adrian Gropper, MD

Three juicy lemons came through my inbox this week. The NY Times published an expose of why hip replacement surgery costs 5-10 times as much in the US as in Belgium even though it’s the same implant. JAMA published research and a superb editorial on the Views of US Physicians About Controlling Health Care Costs and CMS put out a request for public comment on whether physicians’ Medicare pay should be made public. Bear with me while I try to make lemonade, locally, from these three sour economic perspectives.

Here’s a super-concentrated summary of the three articles: The hip surgery is more expensive because, in the US, as many as 10 intermediaries mark-up the price of that same hip prosthesis. Then, Tilburt et al said in JAMA that “physicians report that almost everyone but physicians bears responsibility for controlling health care costs.” The physicians reported that lawyers (60%), insurance companies (59%), drug and device manufacturers (56%), even hospitals (56%) and patients (52%) bear a major responsibility to control health care costs. Finally, CMS is trying to balance the privacy interests of physicians with the market failure that my other two lemons illustrate.

Can we apply local movement principles to health reform? How much of our money can we keep with our neighbors? What policies and technologies would enable the health care locavore? The locavore health system couldn’t possibly be more expensive than what we have now and, as with food and crafts, more of the money we spend would benefit our neighbors and improve our community.

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Medicare’s Observation Status-and Why Attempts to Make Things Better May Make Them Worse

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By Bob Wachter, MD

There are tens of thousands of policies in Medicare’s policy manual, which makes for stiff competition for the “Most Maddening” award. But my vote goes to the policy around “observation status,” which is crazy-making for patients, administrators, and physicians.

“Obs status” began life as Medicare’s way of characterizing those patients who needed a little more time after their ED stay to sort out whether they truly needed admission. In many hospitals, “obs units” sprung up to care for such patients – a few beds in a room adjacent to the ED where the patients could get another nebulizer treatment or bag of saline to see if they might be able to go home. Giving the hospital a full DRG payment for an inpatient admission seemed wrong, and yet these patients really weren’t outpatients either. The Center for Medicare & Medicaid Services’ (CMS’s) original definition of obs status spoke to the specific needs of these just-a-few-more-hours patients: a “well-defined set of specific, clinically appropriate services,” usually lasting less than 24 hours. Only in “rare and exceptional cases,” they continued, should it last more than 48 hours.

A recent article in JAMA Internal Medicine, written by a team from the University of Wisconsin, vividly illustrates how far the policy has veered from its sensible origins. Chronicling all admissions over an 18-month period, Ann Sheehy and colleagues found that observation status was anything but rare, well defined, or brief. Fully one in ten hospital stays were characterized as observation. The mean length of these stays was 33 hours; 17 percent of them were for more than 48 hours. And “well defined?” Not with 1,141 distinct observation codes.

To underscore just how arbitrary the rules regarding observation are, an investigation by the Inspector General of the U.S. Department of Health and Human Services released today found that “obs patients” and “inpatients” were clinically indistinguishable. Their major difference: which hospital they happened to be admitted to.

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Will the Federal Health Insurance Exchanges Be Ready On Time?

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By Robert Laszewski

After months of speculation on just where the Obama administration is toward the development of the new health insurance exchanges, the Government Accountability Office (GAO) has issued a 48-page report complete with timelines and a detailed report on just where the Obama administration is––or at least was last month.

The key summary:

“Much  progress  has  been  made,  but  much  remains  to  be  accomplished  within  a   relatively  short  amount  of  time.  CMS’s  timelines  provide  a  roadmap  to   completion;  however,  factors  such  as  the  still-­evolving  scope  of  CMS’s  required   activities  in  each  state  and  the  many  activities  yet  to  be  performed—some  close   to  the  start  of  enrollment—suggest  a  potential  for  challenges  going  forward.  And   while  the  missed  interim  deadlines  may  not  affect  implementation,  additional   missed  deadlines  closer  to  the  start  of  enrollment  could  do  so.  CMS  recently   completed  risk  assessments  and  plans  for  mitigating  risks  associated  with  the   data  hub,  and  is  also  working  on  strategies  to  address  state  preparedness   contingencies.  Whether  these  efforts  will  assure  the  timely  and  smooth   implementation  of  the  exchanges  by  October  2013  cannot  yet  be  determined. ”

Regarding the Data Hub:

“FFEs  [the federal exchanges] along  with  the  data  services  hub  services  are  central  to  the  goal   under  PPACA  of  having  health  insurance  exchanges  operating  in  each   state  by  2014,  and  of  providing  a  single  point  of  access  to  the  health   insurance  market  for  individuals.  Their  development  has  been  a  complex   undertaking,  involving  the  coordinated  actions  of  multiple  federal,  state,   and  private  stakeholders,  and  the  creation  of  an  information  system  to   support  connectivity  and  near  real-­time  data  sharing  between  health   insurance  exchanges  and  multiple  federal  and  state  agencies.  Much   progress  has  been  made  in  establishing  the  regulatory  framework  and   guidance  required  for  this  undertaking,  and  CMS  is  currently  taking  steps   to  implement  key  activities  of  the  FFEs,  and  developing,  testing,  and   implementing  the  data  hub.  Nevertheless,  much  remains  to  be   accomplished  within  a  relatively  short  amount  of  time.  CMS’s  timelines   and  targeted  completion  dates  provide  a  roadmap  to  completion  of  the   required  activities  by  the  start  of  enrollment  on  October  1,  2013.

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