Vote Yes

BRIAN KLEPPER and DAVID C. KIBBE

One of us was at a local diner yesterday, when a good friend and health plan broker walked up to say hello. This guy delivers premium increases every day to employers, and understands how broken things are. "I hope Congress votes yes," he said flatly. "We've got to finally move beyond the status quo and try to change the system."

As conflicted as we are over it, we agree and we hope it passes. The die is now cast, so there is no point in continuing to urge a different approach. As terribly flawed as it is on cost controls, the bill represents two very important things that, in our opinion, the nation desperately needs.

First, it will significantly open access, bringing America much closer to universal coverage and making personal financial distress a much less likely outcome of sickness or injury. As Nicholas Kristof pointed out Wednesday, that alone will dramatically improve the health of the nation. Widespread uninsurance and under-insurance have been a national disgrace for decades. Passing this bill would be a commitment to move beyond that shame.

Second, we believe the President is attempting to deal with many difficult problems thoughtfully and in good faith within an extremely toxic political environment. We want to see him succeed, because we think that his approach is good for America.

The bill is not what we hoped for. We're disappointed in the behaviors of both parties. But after a year of wrangling, it is what is possible now. There is no reason the bill's inadequacies can't be revisited.

We hope Congress votes Yes on this bill. Making care and coverage more accessible and more fair would be a momentous and long overdue achievement.

The Surprise

Brian Klepper

Check out this March 3rd article - see the image - from the recent HIMSS conference, in which Dave Garets, President and CEO of HIMSS Analytics, "gazes into the future and predicts major trends for the next 12 months." HIMSS Analytics is the research and consulting arm of the health IT vendors' association, and presumably on Health IT's leading edge.

From the article:

"Q: What will constitute the surprise of 2010 - the one technology or policy or X-factor that no one saw coming."

"A: Clinical groupware in the ambulatory market that may be the disruptive innovation of ambulatory EMRs."

For the uninitiated, "Clinical Groupware" is a term that is rapidly gaining traction and that describes a new wave of inexpensive, ergonomic, useful Web-based care management tools. David Kibbe coined the phrase and articulated Clinical Groupware's conceptual framework on this blog early last year - see here and then here. He noted that it:

"...captures the basic notion that the primary purpose for using these IT systems is to improve clinical care through communications and coordination involving a team of people, the patient included. And in a manner that fosters accountability in terms of quality and cost."

Dr. Kibbe formulated his ideas, not in isolation, but in continual discussions with innovators developing great new care management tools - e.g., Docsite, Keas, Relay Health, VisionTree, Medicity/NOVO, Salesforce, Practice Fusion - that were realizations of the concept in one form or another. A group of these like-minded developers founded the Clinical Groupware Collaborative, led now by Steve Adams, the founder of RMD Networks. If you're working in this or an aligned area, consider joining.

Which is all by way of saying that it is a stretch to say that "no one," especially HIMSS, saw this coming. From the moment that HIMSS became aware of Clinical Groupware - it's newfound religion on Web-based and modular approaches notwithstanding - influential members were concerned about the trend's disruptiveness. After all, if you're selling EHRs for $25,000 per physician and a new competitor comes along with complete systems or highly useful modular components for a fraction of that - or even free! - the pricing shift will wreak havoc on your revenue and market cap. It's enough to give even the most enthusiastic free marketeer the willies.

That concern found expression through HIMSS influence over CCHIT's - the Certification Commission for Health Information Technology - certification process. CCHIT's criteria were initially spun to favor HIMSS members' products, mostly old-fashioned client-server tools that are complex and not interoperable, and to stifle support of newer, more streamlined solutions like Clinical Groupware. Remember that, early on, everyone thought CCHIT certification would be the criterion for receiving ARRA HITECH stimulus funding, so the criteria could be used to steer the money, conflicts of interest notwithstanding. Fortunately, cooler heads prevailed on the HHS Policy Committee and that heist was averted, or at least it seems so at this point.

The good news is that Dave is right. Clinical Groupware is evolving rapidly and will seamlessly link tools, care teams and patients. It does look disruptive and undoubtedly is the future. If they're watching, this should give serious pause to all those investors driving up Allscripts stock price.

Because, in the end, many old-guard EHRs - the ones Clinical Groupware will replace - produce dreadful customer experiences like the one described recently by John Moore. His article described a market begging for innovation, where the old guard is locked into its past market domination and excessive pricing, and the users are increasingly frustrated.

Of course the irony here is that Clinical Groupware will most surprise and disrupt HIMSS' member organizations, the core of Mr. Garet's constituency, who thought the matter was settled a year ago.

Brian Klepper writes about health care market dynamics and innovation.

Why Rush Vendor Certification of EHR Technologies?

By DAVID C.I KIBBE and BRIAN KLEPPER

A surprise move by ONC/HHS indicates the wheels may be falling off health IT reform at about the same rate they've fallen off Democrats' broader health reforms.

David Blumenthal and his staff have unveiled two separate plans to test and certify EHR technology products and services. We don't think this is a good idea. We've supported the purpose and spirit of the ARRA/HITECH incentive programs, and believe ONC's/HHS' re-definition of EHR technology puts it on a trajectory to improve the quality and efficiency of health care in the U.S. But this recently-announced two-stage EHR technology certification plan bears all the marks of a hastily drawn up blueprint that, if rushed into production, could easily collapse of its own bureaucratic weight.

The new Proposed Rule puts vendors through the wringer, twice. As defined by ONC, vendors with "complete EHRs" and those with "EHR modules" will have to find an "ONC-approved testing and certification body" (ONC-ATCB) that will take them through a "temporary certification program" from now until end of 2011. Then in 2012, under a "permanent certification program," they'll have to switch over to a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing body for testing, after which they must seek an "ONC-approved certification body" (ONC-ACB, not to be confused with ONC-ATCB) that can provide certification. The ONC-ATCB will be accredited by ONC, but the ONC-ACBs will be accredited by an "ONC-approved accreditor" (ONC-AA).

Confused? This is just the start. We can't imagine many federal agency Notices of Proposed Rule Making (NPRM) that have created, in a single document, more new acronyms. And the prose in the document can challenge even the most focused minds. For example, the drafters of the NPRM recognize that things could get a little complicated, saying:

"Should CMS finalize its proposed staggered approach for meaningful use stages, we recognize that some confusion within the HIT industry may arise during 2013 and 2014 because of this apparent inconsistency and the divergent use of the term “meaningful use.”

But, then they go on to clarify:

"We would anticipate, therefore, that ONC-ACBs would clearly indicate the certification criteria used when certifying Complete EHRs and/or EHR Modules, and identify certifications according to the calendar year and month rather than the meaningful use stage to reflect the currency of the certification criteria against which the Complete EHRs and/or EHR Modules have been certified. Consequently, if an eligible professional or eligible hospital were seeking to obtain a certified Complete EHR or certified EHR Module in 2014, for instance, that eligible professional or eligible hospital would look for Complete EHRs and EHR Modules certified in accordance with certification criteria current in 2014, rather than Complete EHRs and EHR Modules certified as meeting certification criteria intended to support meaningful use Stage 1, Stage 2, or Stage 3. We request comments on ways to ensure greater clarity in the certification of Complete EHRs and EHR Modules."

Got that? Glad they're requesting comments, though we're not sure where to start. The use of the word "staggered" to describe ONC's programs is apt: this new NPRM is going to leave a lot of people staggering, as in punch drunk.

We would like to see ONC and HHS abandon temporary certification in favor of a single, permanent certification process, even if it means delaying testing and certification until mid- or late 2011. The hurry appears to be related to the need to have at least some EHR technology tested and certified by the end of 2010, so at least some physicians and hospitals can meet the meaningful use criteria. That would require them to use "certified EHR technology" by the official start year for the incentive programs, 2011.

But we don't think this timetable makes sense any longer, and the rush may jeopardize the whole program. Between meaningful use, accreditation, testing, and certification, there are simply too many moving parts to implement and coordinate in too short a time.

Delays seem inevitable. For example, we know that the release of the meaningful use final rule will be postponed until early summer and perhaps longer due to the large number of comments received and their implications. A consortium of physician membership groups will soon recommend that the meaningful use criteria be simplified. It also predicts that many small and medium sized medical practices will sit on the sidelines during 2011 and 2012, rather than rush into risky attempts to meet the meaningful use requirements. In addition, CMS has said it won't be ready to accept EHR technology product and service data until 2012, at the earliest. That timeline could be ambitious by about a year.

The ONC/HHS interim final rule (IFR) may have inadvertently caused another kind of delay. It set initial standards and implementation specifications for EHR technology - we applauded this - endorsing a modular EHR technology approach that opens the door to industry innovation. But it will take time for market entrants to bring modules and components to their customers, and perhaps longer to integrate different EHR vendors' modules in plug-and-play fashion. In other words, by opening up the market, ONC/HHS created circumstances that will almost certainly delay the goals it seeks.

So what if, to get the certification process right, ONC were to postpone payments by one year? It would be worth it.

The "permanent certification" plan in this new NPRM is very reasonable. Under it, NIST would be involved in setting up the testing of EHR technology software under the auspices of the National Voluntary Laboratory Accreditation Program. A single accrediting body would be chosen by ONC/HHS to oversee, supervise, and accredit the certification entities, following established international standards, including the International Organization for Standardization's (ISO) standards 17011 and Guide 65, that have guided conformity assessment in numerous industries, and ISO 17025 that is used for assuring quality of testing and calibration laboratories.

So each vendor would follow an orderly progression: first, ensuring that the product meets the technical testing criteria and then, having passed those technical tests, moving on to certification. The stability of this process has much to commend it.

We're not alone in thinking that delaying the EHR incentives start date is a good idea. At a HIMSS session on Monday, March 1, Congressman Tom Price (R-Ga.), an orthopedic surgeon, said that ONC's delay in issuing guidance on the certification process has prompted him to organize Congressional members. They'll send a letter to federal officials asking to postpone the start date for for demonstrating meaningful use to qualify for incentive payments. Price said members of Congress are currently collecting signatures for the letter and could send it to HHS within a week.

David Blumenthal is smart, dedicated, and is hiring many talented, experienced people into ONC. But rushing ARRA/HITECH's policy and statute beyond what is humanly possible could ultimately be at cross-purposes with the very goals they're trying to achieve.

David C. Kibbe, MD, MBA and Brian Klepper, PhD write together about health care technology, innovation, market dynamics, and reform.

After the Failure of Reform

By BRIAN KLEPPER AND DAVID C. KIBBE

The stalemate in the bi-partisan health care summit was cast the moment it was announced. Republicans demanded that the reform process start anew, and Mr. Obama insisted on the Senate bill as the framework going forward. The President may now offer a more modest reform bill that can demonstrate some progress on the health care crisis, but that remains to be seen.

We hoped the White House would seize the opportunity presented by Massachusetts’ election of Scott Brown to begin again, huddling away from the lobbyists to develop a new set of provisions that would include reasonable Republican elements, like medical liability reform, as well as other meaningful cost reduction provisions excluded from the first round of bills: pricing/quality transparency, a move away from fee-for-service reimbursement, and the re-empowerment of primary care.

They took a different path. As Ezra Klein speculated in the Washington Post, Mr. Obama and his advisors may believe that, with the 2010 elections bearing down on Congress, there is too little time to begin again.

But this is a questionable political calculation. The reform process soured the American people and American business on the health care bills. A January 27 Towers Watson/National Business Group on Health (NBGH) survey found that71% of employers believe the bills "will increase the overall cost of health care services in the United States." A February 11 Rasmussen survey found that61% of voters think the bills should have been scrapped and the process started over.

And no wonder. Over the past year, the legalized bribery that is special interest lobbying was fully on display, with members of both parties (but led by the Democrats) taking contributors' money with a gusto unprecedented since the Republican feeding frenzy set off by Newt Gingrich's K-Street Project. A newreport from the Center for Public Integrity shows that "more than 1,750 companies and organizations hired about 4,525 lobbyists — eight for each member of Congress — to influence health reform bills in 2009." Together, they spent $1.2 billion on health care, more than one-third of the $3.47 billion spent by special interests in 2009 to buy influence over policy.

And then there was the brazen political deal making. Mary Landrieu brought $300 million in federal aid home to Louisiana for voting with the Democratic Leadership, which the GOP promptly dubbed "the Louisiana Purchase." Ben Nelson got the Feds to pay for most of Nebraska's Medicaid expansion...in perpetuity. And, on the eve of the Massachusetts Senatorial election, the White House cut a deal that exempted unions from the tax on "Cadillac health plans" until 2018.

The resulting reform provisions - a cynical combination of expert advice, uncompromising ideology and donor quid pro quos - would have extended entitlements while rescuing the industry at the top of a financial bubble, exacerbating the cost growth problem during a recession by replacing dwindling private funding with public dollars. At the same time, the bills specifically avoided committing to approaches that could wring excessive cost from the system.

In truth, either passing or blocking such poor bills would have had little impact on the increasingly threatening crisis. Short of starting over, American health care will continue to face some very harsh realities. More individual and corporate purchasers, particularly small employers, will be priced out of coverage as health care costs explode. This erosion in mainstream coverage is translating to a reduction in total health plan premium - the engine of the health care economy - and to escalating uncompensated care cost loads throughout the system. A plummeting number of insured patients will find it harder and harder to pay for a rapidly growing number of uninsureds and under-insureds.

These are recipes for instability and disaster. And as health care - the nation's largest economic sector, representing one dollar in six and one job in eleven - becomes increasingly unstable, so does the larger US economy.

Americans are increasingly aware that a government in which both parties are compromised by political ideologies and special interests will likely leave them to their own devices in dealing with health care. American business had, to a great extent, put health care benefits decisions on hold until reform was complete. Now it is resigned to continuing to cope with that burden, but with a renewed commitment to innovation. A February 22nd Towers Watson/NBGH survey found that "83% of companies have already revamped or expect to revamp their health care strategy within the next two years, up from 59% in 2009," a clear sign that businesses now think they need to act on their own behalves. (Of course, most individual Americans don't have that latitude.)

One thing is clear. Without reform as it was constituted and the subsidies it promised, the industry faces an onslaught of actions from the marketplace that will focus on its excesses, drive down reimbursement, and hold it more accountable. A long list of innovations - re-empowered primary care; data collaboratives that identify and then create incentives for making the best choices; new technologies like minimally invasive surgeries, point-of-care testing, and clinical decision support tools; medical tourism; clinical groupware; check lists; Health 2.0 business-to-business ventures that streamline health care processes - are now proving they can improve the quality of care while reducing cost.

The result is inescapable. No system this far out of balance can remain unchanged indefinitely. So long as it was influencing the policy process, the health care industry would never course correct in ways that are in our national interest. But as the environment continues to intensify, the market will be driven to embrace and integrate these solutions. One way or another, the health industry is in for real change over the next few years.

Meanwhile, until America meaningfully addresses cost and access through policy, proper health care will continue to be out of reach to many and will threaten many more with personal financial ruin. It will continue to sap the nation's economic strength, and compromise our efforts to lead and compete internationally.

Which is why the President should begin again, and make achieving serious health care policy reform a dedicated goal. In the process, he could challenge special interest influence over policy, and work to refocus the political process on the common interest. We believe the American people can see how the current paradigm is corroding our nation, and would rally behind this approach. More to the point, this was the premise of Mr. Obama's election. The American mainstream is waiting for him to assert his leadership in this way.

Health care reform has stalled and possibly failed for the moment. But the stakes are so great for America that failure cannot be an option.

The Silver Lining

By BRIAN KLEPPER and DAVID C. KIBBE

Massachusett's voters' stunning rejection of Democrat Martha Coakley, in favor of a not-very-impressive Scott Brown, should be exactly the splash of cold water that the Democratic party - and Congress as a whole - needed. The defeat can be understood in two ways: one large and one fairly small.

First, the large one. This will probably send reform back to the drawing board. Health care is too much in crisis and too pressing to be pushed completely off the table until certain issues - including both access AND cost - are addressed.

Second, this election marks the loss of a single critical Senate seat, but it is also very loud warning shot. The mandate received at the end of 2008 was a resounding call to throw out the Republicans who for more than a decade had ridden roughshod over American values. Yesterday, the Democrats, in one of their most secure strongholds, received the same message. Whatever people in DC think, rank-and-file Americans - not those on the right or left, but the swing voters in the middle who actually determine election results - are very unhappy with the gaming that's been vividly displayed over the last year under the guise of health care reform.

The distaste expressed yesterday probably has little to do with the specific provisions of the bills, except for the largest generalities: that they expand coverage while avoiding a commitment to changes that could significantly reduce cost. But along the way, voters have witnessed -- with an immediacy and transparency that has only been available as a result of the Web -- lawmaking in its worst tradition. There was the White House's deal making with powerful corporate interests like the drug manufacturers even before the proceedings began. And the tremendous lobbying contributions by health care and non-health care special interests in exchange for access to the policy-shaping process. Or the outright bribery of specific Senators and Representatives in exchange for votes. Last week's White House deal with the unions that exempted them from the tax on "Cadillac" health plans until 2018 must have seemed like a perfectly OK arrangement to the people in the center of all this activity, but to normal people who read the paper, it was emblematic of the current modus operandi: If you have power and support the party in power's muddled agenda, you get a special deal.

The most tempting mistake now for the Democrats would be to dig in. President Obama's most appealing characteristic -- the one that got him elected -- was his embrace, his embodiment even, of approaches that would revise the traditional kinds of politics we've seen for the last year throughout the health care reform process. Of late, the most telling complaint about this Presidency so far has been disappointment that, once in office, he seemed to cave in so easily.

Undoubtedly, many Republicans are now rejoicing over the Democrats' loss and the possible defeat of any health care reform legislation. That's unfortunate. The health care crisis is real and remains unaddressed. The pressures it creates, particularly for powerful interests like business, will force Congress to return to it and develop meaningful solutions. Hopefully (though probably unlikely), Congress and particularly the Democrats, will be chastened and wiser. There's a big opportunity here to make lemonade.

There is a new, bipartisan movement in Congress, highlighted on NPR two weeks ago, that would revisit the rules around the relationships between special interests and lawmakers. This is an issue that trumps and is more important than all others, because if every policy is ultimately shaped by those with enough money to buy Congress' favor, then our democracy will be unable to hold.

The silver lining in yesterday's election was that it was a mild, if critical, reminder that, whatever DC thinks, America's center is just as displeased with the current governance as it was with its predecessors. Faced with a much larger rejection in the 1994 elections, President Clinton went on TV, took full responsibility, and then spent his time rebuilding. The good news is that today is a new day, and that, if they're interested in what's good for America over the long term rather than simply themselves over the short term, Congress has the ability to start again in ways that could please the American people and actually work to our collective advantage.