The path forward for health reform is becoming clearer now that the dust from the Democrats losing their 60th vote in the Senate is settling.  While a freestanding, comprehensive law now seems very unlikely, achieving the core goals of health reform are possible via the regular order of a Reconciliation bill, demonstrations and pilot programs, waivers, existing authorities, and the appropriations process.

It’s the Stupid Economy
First, the President has appropriately reraised jobs and the economy to be his highest priority.  This shift may both help defuse the hyperpartisaness that has enveloped health reform, and increase action to improve the economy and create jobs since they are the source of the public’s ongoing angst and frustration.  However, the Administration and Congress should continue to pay attention to health reform since people’s concern over the economy and job-lock are partially driven by worries about the affordability of health insurance and healthcare.  In addition, location-lock for small businesses and entrepreneurs because of different state health insurance laws may be supressing job growth in those sectors… something I recently investigated in moving from Massachusetts to DC.

Reconciliation - Part 1
Second, any action related to health reform will need to embrace fiscal responsibility and deficit reduction.  This clearly points towards a Reconciliation bill that reduces the growth in Medicare spending, (and extends its solvency), along with some Medicaid changes to accommodate increasing enrollment while limiting States’ fiscal exposure in a down economy.  This type of Reconciliation bill would be similar to those that both Democratic and Republican controlled Congresses have passed in the last 20 years.  (In the current political alignment, Democrats will have to counter Republicans’ accusations that they are cutting Medicare rather than just slowing spending growth. Both characterizations are “true” depending on your political objectives.)

Strategic Demonstrations, Pilot Programs and Waivers
Just nipping and tucking at Medicare spending and increasing Medicaid’s enrollment and financial support to the States won’t meet anyone’s definition of health reform.  Therefore, to move the US health system along the path of reform to expand coverage, improve quality and control costs, there are targeted initiatives that the Administration and Congress can pursue to push forward with reforming health delivery and financing:

First the Administration can get much more aggressive with its use of Medicare demonstrations and pilots. These can build upon the HIT and CER programs included in last year’s stimulus bill as stepping stones for health reform.  The Administration already started in this direction with their “Demonstration Grants for the Development, Implementation, and Evaluation of Alternatives to the Current Medical Liability System” announced last September.  Granted this program was designed to provide some cover for Congressional moderates and to probably curry favor with some clinician groups, but the Administration also has the ability - and in some cases the legislative authority - for many other types of demonstrations and pilots.  For example, they could:

• Proceed rapidly with the Advanced Primary Care (APC) model type of Medical Home demonstration they announced last September - and which I wrote about previously.
• Resurrect the straightforward Medicare Medical Home demonstration that Congress authorized in 2006 for eight locations. (In 2008 authorization was expanded to as many locations as HHS wants.)  This demonstration was scuttled last fall because the evolving health reform legislation had language replacing it with two new ones.  Since the draft regulations for this program were completed in December 2008, they would just need to be updated and finalized for the program to start later this year or January 2011.  There is also no reason that this Demonstration couldn’t run in parallel with the APC Medical Home demonstration - perhaps in different geographic locations.

For these and other demonstrations and pilot programs, the key for success will be structuring them somewhat like clinical trials so that people and organizations are assessing very similar, if not identical things.  This would not be “cookbook medicine” since these demonstrations should focus on the organization of care delivery and not on individual care decisions. For example, the Medical Home demonstrations mentioned above are about the organization of services provided by primary care practices, not the specific decisions made by clinicians for individual patients.  Similarly, the use of surgical checklists is an operational process that has been shown to reduce errors, increase the quality of care, and reduce costs.  However, it does not specific what procedures the surgeon performs or how the anesthesiologist delivers medicines, etc.

One of the failings of past demonstration programs has been that they have been structured to analyze what people are already doing rather than ways of delivering care that might improve outcomes. For example, the Medicare care coordination demonstration that reported its “conclusions” last year failed to demonstrate very much since it was an evaluation of 15 different types of programs.  In addition, demonstrations are sometimes caught up in significant political and parochial interests.  This was the case for a demonstration program involving “Centers of Excellence” for cardiac care at hospitals.  This demonstration program was scuttled the first time around - and hobbled thereafter - because the hospitals in the demonstration’s geographic locations not deemed “Centers of Excellence” complained quite strongly - particularly to their Members of Congress.

Thus, evaluating what people and organizations are already doing is easy, but may not provide much useful information since care organizations tend to vary greatly in how they operate, even within local areas, so drawing specific conclusions from these types of semi-focused studies is difficult.  Conversely, evaluating specific care practices is harder because it requires changing day to day activities for clinicians and providers, but this type of more controlled experiment can actually demonstrate the value of a change.  And lastly, any of these demonstrations can be undermined by political or parochial forces so that the demonstration is stopped, delayed, or its requirements so diluted that the conclusions are of little value. Thus, to make these demonstrations valuable, career and political officials need to be diligent and have fortitude when they are developing, approving, and overseeing the creation and implementation of such demonstrations and pilots.

Expanded Use of Existing Authority
Once research projects have demonstrated and validated improved ways of delivering care, Medicare, (and possibly Medicaid and other Federal programs), could use their existing authority to pay more for the adoption of these changes - or pay less or not at all when they are not adopted.  For example, Medicare and private payers have stopped paying for so-called “never events,” i.e. clinical events that are completely avoidable and thus should never happen.  Similarly, it is probably within Medicare’s existing authority to not pay - or pay less - for surgeries or the insertion of central intravenous lines when a validated checklist is not used.  These checklists are process steps that have been proven to work and yet have not been universally adopted, which raises the question as to why Medicare is paying for clinical situations where these improvements are not used.

Medicare and Medicaid Waivers
Beyond demonstrations and pilots, and the use of existing authorities, Medicare and Medicaid waivers are other tools that can be used to implement significant changes. Waivers for Medicaid are much more common, and the entire Medicaid program could be viewed as a 50+ bags with 1,000+ waivers.  Technically these waivers are intended to “demonstrate” better ways of running Medicaid programs that would provide information for changing all Medicaid programs across the country.  In practice, these waivers have proliferated like Tribbles in a storage bin of triticale grain, with most States using many waivers for different aspects of their Medicaid programs.  (For example, Arizona didn’t have a Medicaid program until 1982 when it created its program under a statewide waiver. And Massachusetts’ health reform expansion law was only possible because of a revised/renewed Medicaid waiver.)

Medicare waivers are less common than Medicaid waivers, but can be more powerful.  For example,  Maryland’s Medicare waiver has enabled the state to run an all-payer rate setting system for hospitals for many years. And in the near future Massachusetts may be seeking a Medicare waiver to implement an all-payer bundled payment system that their Special Commission recommended last July.  Such a state-wide payment reform system would be an even more dramatic health reform step than the state’s insurance coverage expansion and coverage mandates. But it remains to be seen if the Massachusetts legislature will proceed with this important cost containment and quality improvement step - and if they can get a Medicare waiver when they are ready to ask for it since the Federal Government’s attitude toward such waivers may be different in 2012 or 2014 than it might be today, or was last summer.

Reconciliation - Part 2
It is clear that cost containment for Medicare, expansion of Medicaid, a flurry of demonstrations, pilots, waivers and the use of existing authorities would not constitute significantly health reform since even all together those initiatives would not significantly advance progress towards universal insurance coverage - a fundamental goal of health reform. And one of the criticisms of using the Reconciliation process in the Senate has been that the insurance expansion provisions and coverage mandates in the House and Senate bills would be stripped out under the Reconciliation rules.

However, having successfully included provisions in a Reconciliation bill when I was told that they would definitely be stripped out, I know that under the peculiar rules of Reconciliation all numbers that are the same are are not equal, and there are ways to configure provisions and their implementation to effectively achieve the following:

• Implement significant and strong regulations/requirements/standards to prevent insurance and coverage denials, and pricing problems that are currently permitted under various loose state laws;
• Create strong incentives for insurance coverage for most, if not all Americans;
• Provide subsidies for low income people and small businesses to make health insurance affordable; and
• Reduce the so-called “donut hole” in the Medicare drug benefit.

The first three of these are really the fundamental parts of health reform, and improving Medicare’s Part D benefit is a widely agreed upon goal. The other aspects of the legislation that was moving through Congress are important, but not really essential - and the public plan option has always been redundant and politically explosive pair of suspenders alongside the belt of strong insurance regulations.  In addition, these provisions are also supported by two of the major industries that could have opposed health reform - insurers and biopharmaceutical companies.

There may be some who would criticize the first three of these changes as causing prices to go up, etc. as they transform the health insurance marketplace in most states, but the reality is that this would replicate what has happened in Massachusetts - first with their insurance reforms in the early 1990s, and more recently with their coverage mandates and expanded low-income subsidies.  And despite some public rhetoric, it is working very well, people like it, and it provides stability and security for insurance coverage.  What it hasn’t done is address costs - which is why the state is looking at an all-payer bundled payment system which would give clinicians, provider organizations, and others  incentives to control spending without being intrusive into their care practices.

Paying for these legislative changes will of course be a challenge, but with a renewed focus on fiscal and social responsibility for the Federal Government and financial institutions, there are innovative ways to have all these health reform changes not result in an increase in the Federal deficit.

Conclusions:

• The Administration and Congress should be making the economy and jobs their #1 priority, but should continue to work on health reform since health costs and the vagaries of the health insurance system continue to fuel people’s angst about job security and the overall economy.
• Significant health reform can be done without massive restructuring in one sweeping bill.  Rather coverage can be expanded and costs controlled by constantly pushing and shoving, and massaging and tweaking. Many successful government programs have been built and improved over many decades using such an “incremental” approach - so it is a valid avenue for improving such a complex, multipronged, pervasive, and sinewy “industry” as healthcare.
• Important and significant provisions were included in last year’s stimulus law, and additional government actions should be viewed as building on those initial steps.
• Change is hard, but explaining the immediate and long-term benefits for individuals and society will be important for deflecting politically driven mischaracterizations.  In addition, pointing to Massachusetts’ success with insurance regulation and coverage expansion should demonstrate that such changes work in the real world.  And while many other parts of the country point to Massachusetts as a liberal, “Taxachusetts,” socialist enclave, the state’s recent election of Republican Scott Brown to serve the remainder of Ted Kennedy’s Senate seat should fully refute that mischaracterization.  If a state can elect Scott Brown, then they can’t be all that knee-jerk, socialist-liberal.

Next Steps
The next steps in the annual Federal legislative dance will be the release of the President’s budget proposal tomorrow, followed by the start of the Congressional budget process. The two things to remember about the President’s budget proposal are that it was written and locked up before the Massachusetts Senate election, and this document is generally as much about making political points and sending specific messages as it is about the numbers for specific programs and initiatives. That is, within the Administration’s overall 3 year freeze on non-security discretionary spending there will certainly be proposals for program increases and decreases, but it is Congress that actually makes these determinations. Thus many of the numbers and programmatic initiatives in the President’s budget proposal may be designed to score points with specific groups and to force Congress to make the hard decisions about where to get additional funding for its favorite programs that the President’s budget proposes cutting. For those who thought that President Obama would somehow transform or transcend the Washington political process this may come as a bit of a shock, but the reality is that the framework of the Constitution and the evolving nature of the US government and society promote the separation of powers and a balancing act among them, which at times can look something like an uncivil war.