Politics: Harder Than it Looks

Now that we’re deep in a fractious electoral season, it’s tempting to descend into rank political speculation about health care issues. So let’s get started.

Actually, let’s add a modicum of caution about rushing to precise health policy judgments in the heat of political campaigns. For there’s a tendency to report breathlessly on perceived policy nuance that escapes the mouths of candidates on political stumps that stretch from Sarasota to 1600 Pennsylvania. To be clear, it’s not that what candidates say about health care is somehow irrelevant; what they say informs the electorate, and, for that reason, deserves a careful hearing. But for the media and other listeners to hang on every word is to ascribe literal concreteness to a political process that increasingly muddies the waters between what is said and what is done.

In this, the frenzied season leading up to Supreme Court review of the health reform law, it’s hard to remember 2008, when Barack Obama was the Democratic candidate against the individual mandate. In providing this reminder, we mean no knock on the President, for the tide against which he swims knows no party, engulfing Republicans like former House Speaker Newt Gingrich, whose own journey on the mandate tacks exactly opposite the President’s. But if experienced leaders like these can overrule themselves on so fundamental a question as the individual mandate, what possible credence can be given this or that candidate’s assurances on less overarching issues like IPAB, value-based purchasing, or the Part D coverage gap?

One is tempted toward cynicism, toward writing this off as simply politics as usual. But deeper forces are at work, and they conspire to make it difficult for any elected official to do anything beyond a minuscule number of broad policy strokes for which there is inarguable public consensus.

What are these deeper forces?

On the “input” side — that is, what happens in campaigns — a new law of nature seems to hold that if capacity exists in a communications channel, volume of information must increase until the channel’s full capacity is utilized. This imperative to fill television, newspapers, Web posts, Twitter feeds, and all manner of conventional and social media induces demand for content, which, in turn, requires candidates to state positions more often and in more detail.

Once a candidate is elected, these positions face a grueling process of being transformed into “outputs” — into the actual policies of government. The political tenor for this policymaking was set in motion in 1962, in Baker v. Carr, when the Supreme Court established the “one person/one vote” doctrine, which requires that legislative districts be composed of (virtually) equal numbers of voters. As such, a downstate Illinois farmer’s vote, say, can’t carry more weight than that of a suburban Chicago office worker. As immortalized in a later Supreme Court decision, the key principle is that legislators “represent people, not trees . . .”

While making sense Constitutionally, the “one person/one vote” doctrine operates to enforce a mathematical precision that, over time, has legitimized a new kind of gerrymandering — one in which analytically savvy political operatives, restrained only by numerical equality, draw legislative lines that veer hither and yon to create large numbers of districts colored the deepest blue or the deepest red. These ideologically pure districts produce ideologically pure politicians, who, amplified by interest group echo chambers, often see it as their mission to fuel controversy rather than to seek compromise.

And so it’s not so much that the candidates on the campaign trail don’t mean what they say; it’s more the system being stacked against anyone trying to do what they say, whatever that may be.

So, yes, listen to the candidates and evaluate them on the fundamentals of their health care approaches. But discount the particulars, however mesmerizing they may be, for they will likely fall victim to the greater truth that everything is harder than it looks.

Trees Falling in a Digital Forest

Hombre readers know health policy is nothing if not unrelenting substance, each day a new encounter with deep thinking on ACOs, risk corridors, annual update factors, and similar weighty matters. It’s also an accepted fact that modes of communication have undergone dramatic change. But how, if at all, do the two relate? That is, might the way we communicate be affecting the way we comprehend and address health policy?

In the pre-digital era of 20 years ago, health policy moved lethargically across a relatively barren and uneventful plain. You might pluck a health newsletter from the mail once a week or slip a reimbursement update into a three-ring-binder, or somebody might zap you a fax now and then. But it was nothing like today, when health policy arrives in a blur of always-on coverage that saturates the Web and carpet bombs your in-box, phone, Twitter account, etc.

Paradoxically, we may well know less today than we knew then. That’s because the very plethora of content makes it harder to see — and, if seen, to muster the focus to understand — any one substantive nugget. Indeed, there’s emerged a whole field of open-source intelligence, the basic premise of which is that the best way to hide something is to put it out in public, where it can be effectively masked by the tsunami-like wash of everything else that’s streaming by in “plain sight.”

And so one wonders: If a tree falls in this new digital forest, and no one is around to hear it, does it make a sound?

Sounds were more clearly audible a generation ago, when health care innovators were traumatized by HHS plans to publish an “emerging technology” list (a paean to the idea is here). The innovators’ dilemma, circa 1981, was that the list would help technology assessors draw a bead on new products before they had the chance to make reasonable progress along the diffusion curve. In the context of the times, the concern was understandable because such a list would have stood out and focused attention, and it might well have galvanized unproductive actions against new ideas before they could get a fair evaluation.

It’s only slightly facetious to wonder whether a similar list moving through today’s digital jetstream would even get noticed. For example, dipping into that jetstream over just the last couple of weeks turns up such innovation-centric actions, events, and issuances as these:

That’s just a quick sample; the digital jetstream harbors more that can’t be “seen” because we’re trying to see so much already. It’s as if in the course of 20-some-odd years the Rorschach Test has flipped its fields, rendering invisible the very inkblot images the human mind once perceived as visible.

Oh, and about that emerging technology list? Actually, CMS is receiving comments on the list now — more precisely, on a new list of potential topics for Medicare national coverage decisions (perhaps most fully appreciated in the context of another recent agency move: to rewrite the guidance on coverage with evidence development).

So past may indeed be prologue, even if seeing the connection between the two is getting harder all the time.

Health Care’s Economic Footprint . . . It’s Complicated

It’s now more than obvious that the key U.S. issue for the immediate indefinite future is the economy, and it’s no surprise that an industry as sizable as health care would find itself in the thick of the debate on job creation. But as seems the case with all things health care . . . well, it’s complicated.

From one vantage point, the health care sector can be seen as that rare economic safe harbor that racks up jobs gains month after month. For example, BLS reported 44,000 new health care jobs for September, more than 40 percent of the month’s total employment gains and a continuing moderating force against unemployment’s upward tick, as shown in the chart below. But there are questions about the “quality” of at least some of these new health care jobs.

A recent study by the Federal Reserve Bank of Atlanta, while generally extolling health care’s employment track record in the southeastern U.S., also took note that the future may hold a strong dose of lower-wage positions requiring relatively modest levels of education. A key challenge, according to the report, is to train workers to take on the more sophisticated tasks required to bring to completion such key health care transitions as those to electronic health records and ICD-10 coding.

In this same vein, a proposal by the American Health Information Management Association urges policy incentives to help workers acquire “the core job skills demanded by an integrated electronic health information system” as a means for creating “sustainable, middle class jobs that pay well and offer employment security.”

Everything said thus far assumes the basic desirability of a growing, thriving health care industry. But health care is nothing if not a flashpoint for double-edged swords, and there’s at least one we find ourselves flirting with here: the view that at some level robustness in the health care sector becomes a net negative for the economy as a whole.

This view finds resonance in another Fed report, this one out of the St. Louis district and titled “Why Health Care Matters and the Current Debt Does Not.” Probing the notion that health care is a “superior” good, this analysis finds that the sector has an “unambiguously unsustainable” spending trajectory that is “the overwhelming obstacle” to the nation’s fiscal stability. (Other than that, no problem.)

Similarly, an Alliance for Healthcare Competitiveness proposal to export the U.S. medical “ecosystem” to other nations drew a rebuke from former U.S. Senator and MedPAC member David Durenberger, who, likening the effort to “a parasite eating its host,” sees the health industry’s enviable economic record as directly traceable to heavy government subsidies.

And so the beat goes on as the back-and-forth of competing worldviews long familiar inside health care finds new expression in the broader search for jobs and economic growth.

Innovation: Risk Among the Algorithms

In a much-discussed recent article, “Why Software is Eating the World,” Netscape co-founder Marc Andreesen says we’re in the midst of “a dramatic and broad technological and economic shift in which software companies are poised to take over large swathes of the economy.”

Andreesen sees health care as ripe for software-generated disruption — a point that will not be new to Hombre readers. But while the benefit of better HIT in health care has gotten splashy policy and media attention (e.g., use of IBM’s Jeopardy!-tested Watson for clinical decision support), there’s a subtle risk to health care innovation that seethes just below the surface.

Providing appropriate reimbursement for the fruits of innovation is hard, even in the best of circumstances. On the one hand, innovations are by definition dynamic, representing something different from what’s come before. Reimbursement systems, in contrast, are by nature static, flexing forward only grudgingly, through update mechanisms often as complex as they are lethargic. When moving forces meet static systems, collisions occur.

Software runs the risk of accelerating these collisions by using algorithms to hard wire into health care’s infrastructure misguided or outdated clinical care assumptions. Long gone are the days when HIT was viewed as being about the mere transmission of information. Today, the hardware itself is revealed as just so many dumb pipes; what counts are the outcomes that result from the content that flows through those pipes.

The HHS HIT Policy Committee’s current drawing board, for example, includes requirements for meaningful users of electronic health records to satisfy measures aimed at cutting 30-day all-cause hospital readmission rates, ensuring the appropriateness of a variety of imaging services, and fostering the use of certain named drugs in identified clinical circumstances. Right or wrong, these and other measures embody assumptions about which health care interventions are sufficiently meritorious to earn providers economic incentives.

None of this need be bad, but certainly it is different. Say what you will about CMS, CPT codes, and cost-effectiveness analysis. At least those familiar theaters of contention appear in relatively plain view, with tangible issues and well-worn trails.

The new virtual venues suggest collisions along a hazier, more challenging pathway — one for which innovators may need new capabilities to stake their claims and protect their flanks.

Coverage Policy Provocateurs

Anyone curious about potential future directions in Medicare coverage policy, or simply looking for a detail-packed treatment of this complex subject, can check out the topic via a newly posted Urban Institute report, which includes as authors former CMS coverage policy officials Sean Tunis (pictured below) and Steve Phurrough.

The report rattles around the known world of coverage and evidence, with attention to history and the authors’ own perspectives on what’s worked and what hasn’t. As one measure of the report’s scope, the assorted policy points are illustrated by health care interventions that range from PET, to implantable defibrillators, to Provenge, to alternative prostate cancer treatments, to ESAs, and on and on. The footnotes and cited sources are alone worth the price of admission.

Most provocative are the policy prescriptions, which, in the view of the authors, spring from the role of technology as “the leading cause of health spending.” Seeking to install coverage policy as one pillar in a new conception of value-based purchasing, the report calls for, among other steps, changing the Medicare statute to effect three changes, which, in ascending levels of policy departure, are as follows:

  • Establish explicit legal authority for CMS to undertake coverage with evidence development.
  • “[R]estore and expand” Medicare authority to apply Least Costly Alternative policies.
  • “Allow Medicare to explicitly consider costs as part of the national coverage process.”

Depending on your perspective, these and other recommendations may seem policy nirvana, the ultimate chamber of horrors, or something in between. But whatever your view, give the authors their due: They’ve taken on a nuanced and controversial subject, and they haven’t pulled their punches.

OIG Report is One “Mole” Some Stakeholders May Want to Whack

As the Congressional “Super Committee” moves forward with debt/deficit-reduction efforts over the next three and a half months (the panel holds its first meeting today), look for health groups to reach deep into their playbooks, deploying studies, PR, advertising, grass roots campaigns, and similar exotic tactics to make their case against Medicare and other policy changes. Included, of course, is a much-discussed “run out the clock” option in which health lobbyists help the Committee fail to meet its targets in the allotted time, thus triggering across-the-board (but likely less onerous) Medicare cuts.

In this environment, anything that moves could be significant, so stakeholders intent on keeping a grip will be engaged in an energetic game of “whack a mole,” bringing down the full brunt of their advocacy on any troublesome policy idea that raises its head. We think we spotted one of the furry little creatures Wednesday, when the OIG released a report on Medicare Part B payments for Avastin and Lucentis for age-related macular degeneration.

In a nutshell, the OIG found that the two biologics had “equivalent effects” clinically, but that, over the two years of the analysis, Medicare paid $1.1 billion for Lucentis, versus $40 million for off-label use of Avastin, despite a substantially larger number of reimbursed Avastin treatments.

The OIG noted that Medicare likely lacks legal authority to apply a Least Costly Alternative policy and that Medicare Part B, unlike Medicaid, cannot extract drug rebates. In commenting on the report, CMS, while expressing comfort that “our coverage policies accurately reflect the available published evidence on the use of these agents,” also said that “we will continue to actively monitor the evidence and will, if appropriate, implement changes to our policies as the evidence base continues to grow.”

Hard to say what the OIG report means in the greater scheme of things. But one point is almost certainly understated, and that is, as the OIG put it, that any CMS policy tilt toward utilization of Avastin “could be controversial.” You can count on it, just as you can count on multiple mole sightings over the next several weeks.

The Studies of August

At the very time we’re tempted to sneak a snooze in the hammock a last time or two, we’ve been jarred from our late-August stupor by a traffic jam of reports emanating from a variety of government bodies. Oblivious to the rites of season, studies like these cycle through the landscape on their own unrelenting schedules, providing essential lubrication for the thrust and parry of health policy.

From the bounty of the last few days, here’s three reports of particular note:

    • One key riddle at the heart of the health reform law is the essential benefits package. The law gives special responsibilities in this area to IOM, which, as part of its charge, has now published a workshop report on essential benefits. If you read nothing else: Check out Chapter 5, where Alan Garber takes on medical necessity and use of evidence.

Finally, as if to remind us that the rhythms of research are indeed unceasing, the Patient-Centered Outcomes Research Institute has requested proposals from vendors willing to provide recommendations on a topic that seems pivotal to the Institute’s mission: a working definition of “patient-centered outcomes research.”

We’ll look forward, in a future post, to reporting how this PCORI project turns out. But for now, the hammock beckons.

CMS, GAO Underscore Ebb and Flow of Quality Measures

That development and use of quality measures can be an excruciatingly gradual process marked by policy ebbs and flows was pointed up by two items that came across the transom of our research platform last week.

On the one hand, quality-measure proponents might see forward momentum in CMS’ request for comments on development of a new, more comprehensive measure of hospital readmissions. Before now, much of the agency’s attention had been directed to readmission measures targeted to discrete areas, such as COPD and vascular procedures. But a Yale New Haven draft methodology report for a new all-condition readmission measure sweeps in a much broader group of procedures (check out Table 1). Comments are due August 29, and CMS seeks feedback in areas like inclusion and exclusion criteria; organization of cohorts; and choice of covariates for risk adjustment.

In contrast, the second item serves as a reminder that actually implementing quality measures can be a hard slog. In a report on the Medicare physician feedback program, GAO noted difficulties in using quality measures in a way that is “meaningful, actionable, and reliable.” The report says additional steps — such as more physician input on the “usefulness and credibility” of individual measures — are needed before a workable value-based payment system can be put in place.

Alas, quality measures, like much else in life, may require taking at least one step back for every two steps forward.