Off-Label Communications: Is More Less?

Posted on October 4, 2009 by Michael D. Miller MD

Allergan corporation has filed a law suit against the Federal government challenging the FDA’s limits for companies discussing or promoting off-label uses of approved medicines. This is not a new issue, but the news reports indicate that Allergan is going very old school and basing their legal challenge on Constitutional freedom of speech rights.

The issue is not can doctors and patients use approved medicines for conditions, (or in ways), which are not specifically approved by the FDA, but can companies discuss these off-label uses with physicians or provide them with published information about these off-label uses?

Competing Risk-Benefit Perspectives
The competing risk-benefit perspectives that surround this issue are nearly identical to the trade-offs that all stakeholders in biomedical research and development face – including the FDA, companies, patients, clinicians, and legislators:

Creating a landscape that protects individuals and public safety
Being flexible enough to provide clinicians and patients access to the best available treatment possibilities
Providing companies a reasonable market environment that creates incentives for developing new treatments and investigating new uses for already approved medicines, which also has marketing rules that are as clear as possible so companies can conduct business without being excessively concerned about straying into regulatory gray zones

Off-label use is common in clinical practice – particularly for disease areas like cancer – because it often represents the standard of care. And in situations where a medicine approved to treat a common condition has an off-label use for a rare condition, the company has very little incentive to conduct the expensive and time-consuming clinical research to get the FDA to approve that rare off-label use.

There are a few key points underlying the issue of communicating information about off-label uses:

The Constitutional freedom of speech rights for a company are not as expansive as for an individual
The FDA’s regulatory authority focuses on the approval for sale and marketing of medicines, (and some other product areas), and not their use in clinical practice – with some very rare exceptions
The FDA’s position about companies disseminating information about off-label uses has not be fixed in stone

On this last point, the 1997 FDA Modernization Act included a provision to expand the ability of companies to give physicians journal articles and similar material about off-label uses of approved medicines. After that the Washington Legal Foundation brought a law suit seeking to expand off-label information dissemination. And when the FDAMA provisions expired in 2006, the FDA proceeded with rule-making guidance to replace the FDAMA provisions, and this final guidance became effective in January 2009.

Not having read the details of Allergan’s legal challenge – and since the FDA doesn’t comment on current suits – it’s hard to assess the specific pros and cons of their positions. But considering the extensive legislative and case law involving this issue, the company certainly seems to have a very steep hill to climb. On the other hand, it would seem unusual that they would spend the time and money to bring a legal challenge unless they felt they had a chance to prevail. However, Allergan’s suit may have implications for the FDA, industry, clinicians, and patients for several or many years – even if they lose – because they may be making a pretty big splash in the policy pond with such a public challenge to change the rules for off-label promotion, and this will likely alter the landscape for any future actions.

I was involved with a somewhat analogous situation in the mid-1990s where a lot of groundwork had been done to prepare for a substantive debate about reforming a fundamental life sciences policy issue. However, one company had an urgent and particular need for a legislative change, and they proceeded to pursue every reasonable and extraordinary avenue for getting the change they wanted. The end result was that all our subsequent discussions were short-circuited because every policy stakeholder’s response upon raising this issue, was “Oh, I know about THAT issue,” with the implication that it was something they wanted nothing to do with because of the controversy the one company had stirred up with their expansive activities. (I’ve purposefully not named the issue so as to not perturb anyone or any company about something that happened years ago.)

Collective Sausage Making
The moral of this story is that to make productive changes stakeholders within and across groups frequently need to work together. And if they don’t, the well can easily get polluted for everyone when policy makers avoid any action because they connect the issue to a nasty smell. This may be another manifestation of the old adage, “the two things that shouldn’t be seen being made are laws and sausages.”

What is Health Reform, and Why?

Posted on August 6, 2009 by Michael D. Miller MD

As Congress enters the August district work period, (the official name for the August recess), the debate about health reform has shifted from Congressional hearings and mark-ups to local Town Hall meetings, the media, (print, talk radio, talking heads on TV, and the blogo-YouTube-osphere), and the astroturf campaign styled world of organized phone banks, shout downs, and meetup/get-together rallies/service days.

Proponents and opponents on all sides are participating in and supporting all these types of activities. But the questions I keep getting are, “what is the proposal?” “What is in the President’s bill?” “What is health reform?”

Simply answered, 1) There is no single proposal – three House Committees have passed bills, (which need to be melded into one bill for consideration by the full House of Representatives in the fall), and one Senate Committee has passed a bill and another is still trying to cobble together a bipartisan bill; 2) The President has 3-4 principles, but doesn’t have his own “bill”; and 3) That is still being determined – but if you listen to the escalating frenzy, (which is why I frequently wear earbuds that may or may not be connected to an MP3 player), health reform is all about a public insurance plan option.

Health Reform Centering on a Public Plan Option
So why is the debate focusing on a public plan option? Probably because it serves as a fulcrum for many of the hot button sound-bites on both sides:

A public plan option is necessary to create competition in the insurance marketplace
A public plan option is necessary to provide competition to private health insurance
A public plan will keep the private insurance companies “honest” by creating a competing organization that won’t be concerned about profits
A public plan is the first step to achieving a single-payer health system
A public plan is a government take-over of the healthcare system
A public plan is socialism
A public plan is the first step to a college football Bowl Championship playoff system – OK nobody has said that…. yet

What is a Public Plan, and Why?
As I’ve written in the past, there has been many descriptions of what a public plan could be – ranging from the Federal Employees’ Health Benefits Program (FEHBP) to traditional Medicare – and yes, Medicare is a government program despite some media reports of individuals telling Members of Congress to “keep the government out of Medicare.”

Obviously the structure of a public insurance plan would determine its affects on the US healthcare system. While analyses of all possible public plan options haven’t been conducted, a few have looked at how much could be saved and how many people might enroll in a public plan that looks something like Medicare – but paid higher rates to doctors and hospitals, and was run more flexibly than traditional Medicare.

John Sheils at the Lewin Group released a report analyzing this type of public plan option, and a more recent report from the Urban Institute expands on that work and makes the case that this type of public plan option is needed to increase competition in the health insurance marketplace because there has been significant consolidation in recent years. The Urban Institute’s paper makes some compelling arguments, but its analysis also combines creating a public plan option with national insurance reforms, (i.e. replacing state based insurance regulation), and national or regional health insurance exchanges. Since each of these three initiatives, (public plan, national regulation, and an exchange), would change the competitive landscape of the health insurance market, it would be helpful to have analyses examining each of these ideas alone and in different combinations. [Note - the Urban Institute released a report in April about Health Insurance Exchanges, which discussed how exchanges can increase competition and consumer options by reorganizing the market for health insurance.]

An informative real-world initiative about what the combination of insurance regulation and a health insurance exchange can accomplish has occurred in Massachusetts. With insurance regulation historically being the responsibility of the states, Massachusetts has had rather stringent regulations, (for example, see this chart from the Georgetown University Health Policy Institute), which is why none of the media stories about individuals being denied coverage by their insurer for apparently necessary care have come out of Massachusetts. On top of this strong regulatory environment, in 2006, the state created the Commonwealth Connector exchange to make 3 levels of insurance packages from several insurance companies available to individuals and small companies across the state.

Has this increased competition, transparency, and the ability of individuals to compare plan options? Yes, yes, and yes. Has it controlled the growth in health insurance costs? Maybe a bit – but not enough because insurance costs reflect the underlying cost of care people are getting, and insurance regulation and an exchange alone aren’t going to “bend the curve” in healthcare costs. So it could be argued that the purpose of a public plan option is cost containment, and the Urban Institute’s analysis concludes that there would be system-wide savings from the public plan option. However, these savings are based on the public plan paying lower rates to doctors and hospitals, and thus competitively driving down all prices and costs – rather than any br0ader healthcare delivery reforms resulting in improved quality and efficiency.

Answering the Question
So while health reform options have been debated and analyzed, there still seems to be many questions about what health reform will be when Congress finally comes to some semi-consensus around one bill in October, November or December. What is clear, is that whatever this is, it will be called “health reform.”

But beyond what is in that bill there is a lot more that should be considered “health reform.” Specifically, earlier this year, Congress allocated $1.1 billion for comparative effectiveness research, $10 billion more for NIH research, about $30 billion for implementing health information technology, expanded SCHIP (an existing public insurance program run by the states) to cover an additional 3 million children, empowered the FDA to regulate tobacco, and are examining ways to improve food safety and other initiatives outside of the “health reform” bill to improve the health and well-being of Americans – both through targeted legislation and changes to regulations and government operations.

So what is health reform? It’s going on all the time in many places and ways. Some of it is happening at the state and local levels, some of it is happening at the Federal level, some of it is happening in the private market, (with large employers working together to improve the healthcare they are buying), and some of it is happening within health delivery systems that are working with organizations like the Institute for Healthcare Improvement to improve quality and reduce costs.

While the focus has been on doing “health reform” this year, the reality is that we will have to keep “doing” health reform for many years to really make significant improvements. This process of health reform is like making a good red wine: It takes several years after the vines are planted before they bear fruit – and they must be regularly fertilized and tended to. It then takes several more years before the harvest is good. And making the wine requires that the grape squeezings ferment to produce the beginning of the wine which then must age to make a really quality product.

Easy? No.
Time consuming? Yes.
Worth the time and effort? Yes.
What’s the alternative? Whining about why “health reform” hasn’t happened.

Healthcare Policy and Healthcare Politics – Summer 2009

Posted on May 26, 2009 by Michael D. Miller MD

As Congressional Committees appear to be steadily walking towards the starting line for considering health care reform legislation next week, I’ve been thinking about various healthcare policy and political events and activities that will influence the substance and process for these efforts over the coming months – and perhaps years.

Because a complete examination of all the important events and documents from the last several months and years would be too long for a single post, summarized below are some of my observations and thoughts about the meaning of 5 touchstones that people will likely reference in the coming months as part of the health reform dialogue:

Massachusetts’ health coverage and reform initiative
The Senate Finance Committee’s 3 Policy Option Papers
Frank Luntz’s health care talking point paper for Republicans
The May 11th letter from 6 national groups to President Obama
The Democratic Party’s development of Organizing for America

As discussed below, each of these activities and documents has dual (or dueling) policy and political goals, (i.e. changing policy to improve the healthcare system, or designed to win political points), that may be aligned or in conflict.

1. Massachusetts Health Coverage and Reform Initiative

The original legislation was a political compromise that included:
- The use of private insurance to expand coverage
- An individual mandate
- An employer penalty for not having all their workers insured (a.k.a. play or pay)
Single payer is discussed and supported in Massachusetts, but wasn’t part of the state’s health reform initiative
The state’s Commonwealth Connector insurance exchange doesn’t include a public plan choice/option
Despite not being a single payer system, nor including a public insurance plan option, the state’s initiative expanded insurance coverage to more than 97%
With the success of increased insurance coverage has come expanded demand for primary care services and subsequently longer waiting times for those services
The state is looking at various processes for controlling costs as a second outcome to be achieved
The state’s ability to control health care spending will likely require Federal regulatory and/or legislative cooperation from programs such as Medicare, Medicaid, and ERISA

2. Senate Finance Committee’s Policy Option Papers

Between April 29 and May 20th the Senate Finance Committee released 3 papers describing options for health delivery system transformation, expanding coverage, and cost savings and revenue raising. (The Committee also held hearings on these papers.)
The overarching theme in these papers is transparency and accountability
Several issues are notable for their absence from the papers:
- Discussion of a single payer option for overall reform
- Cost savings estimates for a public plan option
- Changing or repealling Medicare Part D’s “Non-Interference” provisions as a source of revenue
The only mention of ERISA is in the savings and revenues paper – It is not discussed in the context of health delivery transformation or expanding coverage
Medicare’s physician payment formula problem is discussed, and the cost of a 10 year freeze is cited as $285 billion
Accountable care organizations (ACOs) and care coordination are frequently mentioned goals, but the papers generally only propose demonstrations or pilot projects rather than definitive programmatic changes

3. Frank Luntz’s “The Language of Healthcare 2009″ Paper

This paper advises Republicans how to talk about healthcare in a purely political context. It doesn’t substantially address policy aspects of health reform issues, and it is all about winning as many Republican and moderate hearts without considering their minds
The goal of Luntz’s talking points are to paint Democrats’ health reform plans as leading to government bureaucrats making health care decisions, rationing of care, and denying access to necessary care
The paper builds upon the premise that patient-doctor relationships are good and that government bureaucrats are bad. It specifically states that the Democrat’s “government takeover” of the healthcare system will result in a bureaucrat putting “himself between you and your doctor, denying you what you need”
Luntz’s paper leverages people’s fear about loss of control and autonomy, but it doesn’t address people’s immediate and real concerns that high costs are denying people access to the insurance or care they need – in effect rationing based upon the ability to pay for the ~49 million people in the US without health insurance and the millions more who are underinsured because they can’t afford their co-payments or deductibles

4. May 11th Letter to the President from 6 National Groups

The 2 page letter from AdvaMed, AHA, AHIP, AMA, PhRMA, and SEIU is mostly political posturing
The letter uses all the right phrases:
- “access to affordable high quality health care”
- “transform the health care system”
- “transparency that supports effective markets”
- “aligning quality and efficiency incentives”
- “encouraging coordination of care”
- “adherence to evidence-based best practices”
Karen Ignagni deserves big kudos for pulling together the other 5 groups and getting agreement for the letter, but herding their collective seagull-like members into agreement for specific reform proposals – other than an individual mandate to have insurance – will be a much bigger challenge, as Paul Krugman recently discussed in his recent column
Getting all these groups to the same side of the same table is a success of process, but not a successful outcome. A collective meeting of minds of similar groups was necessary for the enactment and implementation of Massachusetts’ coverage expansion law, and it is also being used in the state’s efforts to control the growth of healthcare spending

5. Organizing for America (OFA)

The Democratic National Committee (DNC) is working to develop OFA as a program to capture the grassroots energy and organization of the Obama campaign, with the goal of using OFA to support the Administration’s policy initiatives – the first of which is healthcare, to be followed by energy and education
On May 16th I attended an OFA-MA organizing meeting – along with about 500 other people from around the state. The open Q&A and my discussions with individuals made it clear that single payer has strong and wide support in this group, despite candidate and President Obama’s consistent message that if we were designing a system from scratch, single payer would be an attractive option, but given our immediate needs and problems, other significant targeted changes are needed to improve people’s lives by increasing coverage and controlling costs quickly and effectively. (Not too mention that such targeted changes face much lower political hurdles than a single payer reform option.)
OFA is gearing up for Congress’ consideration of heatlhcare legislation by organizing house parties across the country on June 6th to gather individual stories and prepare the OFA grassroots rooters to engage their elected representatives, the media, and whoever else they can reach on healthcare reform

Conclusions

How to pay for health reform still hasn’t been determined, and this summer Congress will also have to “fix” Medicare physician fee schedule – which will cost about $20 billion/year
The most difficult aspects of health reform, (outside of paying for it), are how to do risk/severity adjustments for payments and quality analyses, how to measure the success of initiatives using a blend of process and outcome measures, and how to estimate, (or “score”), costs or savings from many of these initiatives – particularly for those that involve behavior change, disease prevention or health promotion, or are expected to act synergistically with other initiatives, such as patient-centered medical homes or other care coordination intensive models
Agreement on principles is easy, but agreeing to specific proposals is difficult because one person’s waste is another person’s income
ERISA is the 500 pound gorilla-issue sleeping in the corner
Massachusetts is different than most other parts of the country – both in terms of policy and politics – but its experience presents valuable lessons about the process for bringing stakeholders to the same table and for creating a health insurance exchange with low-income subsidies
Politics will be required to enact national health reform legislation, but the specific policies put into new laws will be important for determining their success or failure upon implementation, because a disconnect between politics and policy can result in legislation that produces outcomes different from what are intended. For example, the Balanced Budget Act of 1997 changed the Medicare managed care program, (and renamed it Medicare+Choice), with the goal of expanding managed care options for people enrolled in Medicare. However, following BBA ’97 Medicare+Choice options decreased rather than increased. In addition, success or failure of one initiative sets the environment for the next, e.g. the failure of BA’97 to expand Medicare+Choice enrollment created the context for the development of the Medicare Part D prescription drug program in 2003. Similarly, the success of Massachusetts’ expansion coverage law has enabled the state to explore options for controlling overall health spending as a next step – something that would not have been possible if the expansion law had failed or been derailed…… as it had been twice before.

Footsteps

Improving Cancer Care in Medicare

Posted on May 5, 2009 by Michael D. Miller MD

This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA). The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature. This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited. That is, under current law, for non-cancer illnesses, Medicare Part D plans can still limit coverage to only the off-label uses listed in the standard compendia.

American Medical News ReachMD Interview May 5, 2009:
Off Label Coverage by Medicare Part D Plans

I had recommended that the MIPAA change go beyond cancer to include serious or life-threatening conditions – terminology that is somewhat imprecise, but widely recognized, including by the FDA. However, I suspect that because of cost concerns, this broader expansion of off-label coverage was not included in MIPPA. I find this interesting for two reasons. First, in these times of record government spending, even MIPPA’s limited coverage expansion for off-label cancer treatments raised some concerns about cost increases – which I wrote about in January. And second, that restricting coverage of treatments in this way seems philosophically opposite to the intended benefits of Comparative Effectiveness Research – which is all about using the best research findings to improve the quality of care. Of course, with the size of our health care system, I’m sure this won’t be the last time the left and right hands are not perfectly in sync.

Business Perspectives on Comparative Effectiveness Research

Posted on May 2, 2009 by Michael D. Miller MD

Comparative effectiveness research continues to be a hot health policy issue for many companies and stakeholders, in part, because they’re concerned that CER information will be used to deny access to innovations because of cost.

I recently talked with Jeff Sandman, CEO of Hyde Park Communications, about how healthcare companies should productively approach CER issues, and how quickly CER would lead to dramatic changes in the healthcare system. (See part of our conversation below.)

There will certainly be more reports, seminars, meetings and Congressional hearings about CER as the $1.1 Billion in ARRA funding for CER is distributed, and the results of that research begins to roll in. I’ve written about CER in the past, (see here and here), and expect to continue writing and talking about it in the future – and I would be very interested to hear anyone else’s perspectives on this issue and how they think it will impact the transformation of healthcare.

30% Off Health Care

Posted on April 27, 2009 by Michael D. Miller MD

I get lots of emails. Some are interesting. Others are Spam – such as the one offering to double my gas mileage by showing me how to run my car on water. (Don’t they know that cars run on air not water!!!!!)

And last week I got one promising to cut health care expenses by 30%. Not just my health care expenses, but the entire countries spending on health care. (See their promotional coupon below.)

As you can see, this is really a call for people to support a public plan as part of health reform. This is a great message and marketing gimmick, but the problem is that nobody has agreed on the definition of a “public health insurance option.” For example, Nancy-Ann Deparle, (Director of the White House Office of Health Reform), has said that a public plan could be like the Federal Employees Health Benefits Plan, which offers government employees a range of private insurance and managed care options. But I haven’t heard anyone suggest that the FEHBP has reduced costs or premiums by 30%.

The 30% figure probably came from the Lewin Group’s analysis of how many people might go into a public plan option and how much it could save. Their report put some numbers around the obvious conclusions that the lower the prices the government plan paid for healthcare products and services, the less it would cost and the number of people going into such a plan would be greater. They specifically found that, “If Medicare payment levels are used in the public plan, premiums would be UP TO 30 percent less than premiums for comparable private coverage. [emphasis added.]

Another factor that could influence the structure of a public plan, (if one is created in this thing we’re calling health reform), is that paying for healthcare care based upon each service, (a.k.a. fee-for-service), is being widely blamed as a prime cause for healthcare inflation. And many payers – including the state of Massachusetts – are looking for other ways to pay for healthcare, such as making payments based upon quality or complete episodes of care….basically anything but fee-for-service (FFS). Thus, the long term viability and cost savings of a public plan based upon Medicare-like FFS reimbursements is questionable. However, creating a public plan based on payment systems that aren’t yet widely used – such as global payments – also seems problematic. And going the route of Massachusetts, (whose Connector is very much like FEHBP), seems too simple and probably won’t produce significant near term savings.

All this leaves me wondering what will happen, and if there are fourth, fifth, or sixth options?

Culture of Health Reform

Posted on April 13, 2009 by Michael D. Miller MD

One of the challenges for health reform legislation is the culture of the policy and political community.

Massachusetts’ insurance and coverage initiatives have been cited as lessons for health reform at the Federal level and other states. However, while observing a meeting of the state’s Special Commission on the Health Care Payment System last Friday, I was struck by how the culture of this group was very different than what I have often seen in Federal processes or within other states.

The Commission had agreed at their previous meeting that global payments should replace fee-for-service as the main payment route for medical services and products. At Friday’s meeting their discussion about what that system of global payments should eventually look like – and how to get there – was not confrontational, even though the Commission’s representation includes a wide range of stakeholders, including doctors, hospitals, two insurers, the state employees’ insurance plan and two elected representatives.

The collegiality and non-confrontational atmosphere of this Commission compared to national discussions of similarly broad groups – such as the Health Reform Dialogue – may provide important insights for other health reform efforts. The reasons why health reform in Massachusetts has this type of culture is probably a long list, but some of them might be:

The stakeholders realize that payment reform is part of longer-term cost containment efforts that will be necessary for the overall success of the state’s insurance expansion program
Despite the overall economic downturn, the state and its healthcare system are generally better off than other states and healthcare operations
The state has a generally progressive bent, and is somewhat culturally aligned, e.g. almost everyone is a Member of Red Sox Nation

Whatever the reasons for the agreeablity within the Commission and the state, progress thus far has been a significant achievement, and could lead the way for significant reforms at the Federal level or within other states – particularly if they can replicate a similar culture of cooperation and agreement.

Next Challenging Steps
Of course, the Special Commission won’t be making all the detailed decisions necessary for actually reforming payments, such as:

How quickly the new system will be initiated
How much the global payments will be
Who will get the global payments, e.g. hospitals, integrated delivery systems, physician groups, or some combination of providers
What types of quality information those receiving the payments will have to provide
What levels of cost containment will the new global payment system be expected to meet – and what measurements will be used to determine if costs are being constrained appropriately

Those types of decisions will be made by the state legislature and a government agency – or para-governmental entity created for these purposes. These upcoming decisions and their implementations will be where the even harder challenges await. However, given the Special Commission’s progress so far – and the state’s ability to implement and sustain the insurance expansion program – the likelihood that these harder steps will at least be partially successful seems good. So while critics have been predicting the downfall of the Massachusetts insurance coverage expansion experiment because of rising costs, that’s not the future I see.

The political and policy leadership in Massachusetts seem to have a sustainable group-think and desire to keep on the path they’ve started on rather than veering off into another direction to achieve immediate cost savings or politically expedient gains. The ability of the state to do this will be aided by some of the factors postulated above, as well as the political clout the state has in Congress, and the Governor’s relationship with the President. But those factors may change with time, so the ultimate ability of the state to sustain ongoing reforms and improvements to the healthcare system within the state may very well depend upon its momentum of success. They’ve had great success in reducing the number of people without health insurance. Now cost containment via payment system reform is the next success that must be achieved.

Managing Expectations for Federal Health Reform

Posted on January 28, 2009 by Michael D. Miller MD

One of the challenges facing health reform legislation are the expectations of different stakeholder groups – many of whom were strong supporters of the Barack Obama’s campaign. Although the new Administration has only been in office a week and a day, a number of signs point to the fact that health reform legislation will not be quickly formed and passed – including an article in today’s Boston Globe titled, “Some fear window is narrow for healthcare overhaul.”

But not rushing health reform was both predictable and a good thing. First, the reasons why it won’t happen quickly:

It takes time for the new Administration and Congress to get organized – and they are rightly prioritizing actions to address the economic “situation”
The US system of government is designed to be deliberative and not speedily make major decisions
For reasons that are not fully apparent, the Senate is taking longer to confirm Tom Daschle as Secretary of HHS – although there are no signs that this won’t happen soon
Senator Kennedy’s health has been a question mark, but his staff has been working diligently to prepare legislative framework and language in conjunction with other Congressional offices such as the Finance Committee
Congressman Waxman’s taking over the Chairmanship of the Energy and Commerce Committee will likely mean some staff turnover in that Committee which also takes time – particularly since Congressman Waxman is known for getting some of the best and brightest staff in Congress

And second, not rushing health reform legislation through the process may be a good thing because no matter what scope and details the legislation eventually includes, getting more groups comfortable with its goals, priorities and specifics will make it more likely to succeed. Some might argue that getting it done quickly will prevent any opposition from building up steam to defeat or derail it, but I believe that any interest groups seeking to do that will be more organized and quicker to the trigger than many others who would support it but might need more time to understand the legislation and rally their forces in its favor.

In addition, no matter how quickly legislation is written, passed by Congress, (and presumably signed by President Obama), it will still take a long time to implement. For example: Regulations will have to be written, published for comment, revised, and published in final form; Government programs will have to be revised or created – which entails moving people around or hiring new staff, and creating new forms and procedures for individuals and companies to report information to the government about their health benefit, etc.; Private companies will have to submit proposals for participating or providing services to the government for any new health programs (i.e. health insurance exchange, or new insurance plans).

All these things take time, so that actual substantive changes in how people get or pay for health insurance, how companies pay for employees benefits, or how the government regulates or provides health insurance will likely not occur for months or years after new laws are signed. The exception to that process of course are modifications or expansions to existing programs – which is why the stimulus bill is looking at providing financial relief to states for their Medicaid and SCHIP programs to prevent or minimize cut-backs in those health insurance options for low-income individuals.

The bottom line is that health reform will be a long roller-coaster ride. So pull down the safety bar until it locks in place, buckle your seat belt, keep your arms inside the car, don’t throw anything that could hurt your fellow riders or onlookers, and if you begin to feel ill, remember that everyone’s on the same ride, there will be dips and calm periods amidst the twists and turns, and this time it will most likely get done – eventually.

Improving Cancer Care and Medicare’s Cancer Coverage

Posted on January 28, 2009 by Michael D. Miller MD

The New York Times and Wall Street Journal both had articles yesterday about a new rule clarifying how Medicare would decide whether or not to pay for off-label uses of medicines to treat cancer. These articles describe controversies around Medicare relying on several compendia containing information about such off-label uses to make these coverage decisions, how some of the compendia may have industry connections, and how the new rule might increase Medicare spending.

I have a long history with this issue. As a Legislative Assistant working for Congressman Sander Levin in the early 1990s, I was very involved in writing the legislation that first changed Medicare law to require Medicare Part B to pay for off-label used of medicines to treat cancer. This change was seen as promoting both good medicine and good fiscal policy: It promoted good medical practice because there was evidence that physicians were admitting patients to hospitals to give them off-label chemotherapy for cancer because Medicare wouldn’t reliably pay for it in outpatient clinics. Thus, patients had to travel farther, and were potentially at risk for hospital acquired infections and other problems from being in the hospital when they didn’t need to be. And it was good fiscal policy because Medicare was paying more for these patients to be in the hospitals than it would for them to get the same treatments as outpatients. This is why the Congressional Budget Office estimated that this change to Medicare law wouldn’t cost Medicare any money. (They estimated saving for Part A of Medicare, and some additional costs for Part B, with the net costs being essentially zero.)

What the Times and Journal articles don’t mention is that under Medicare law, off-label coverage for cancer treatments also occurs if there is “supportive clinical evidence in peer reviewed medical” journals that have been approved by the Department of Health and Human Services. (See the language for the entire provision in Section 1861(t)(2) of the Social Security Act.) The peer reviewed literature option was included so ensure that Medicare paid for appropriate off-label cancer treatments for very rare or unusual cancers and treatments that might never make it into the compendia, and to include the most up to date published information for making coverage decisions.

The 1993 law, and the subsequent refinements to it, were designed to improve Medicare’s coverage for cancer treatments. With about 50% of people with cancer being over age 65, Medicare’s policies thus drive many decisions about cancer treatments for all Americans. And despite the requirements for off-label coverage, being treated for cancer certainly presents huge medical and financial burdens for many people – something that the creation of the Medicare Part D outpatient prescription drug program was intended to help with. However, because of a peculiar wording in the 2003 law that created the Part D program, the coverage for off-label cancer treatments under Part D was more restrictive than under Part B. (Essentially, it was easier to get Medicare to pay for an off-label cancer treatment when the medicine was injected by a physician than if the medicine was a pill.) Fortunately – after a lot of discussion and lobbying by patient advocacy organizations including the Medicare Rights Center – that situation was changed by Congress in the summer of 2008. So as of January 1, 2009, the rules for off-label coverage for cancer treatments are the same under both Parts B & D – although I’m sure there will be some snags and bumps in getting all the Part D plans up to speed on how to appropriately apply these coverage rules.

Balancing Costs v. R&D Incentives
How to control the costs of such treatments while also providing incentives for the development of new and better medicines is a difficult public policy balance. Higher reimbursement amounts for cancer treatments would increase the incentives for developing new and better treatments and cures for cancer. But high reimbursements could also increase costs for patients and their insurance companies. This balance becomes particularly difficult when a new treatment is much more effective than previous treatments, it doesn’t produce very unpleasant (and costly) side-effects, it needs to be taken much less frequently, or if it actually produces a cure. In such cases, the new medicine’s very high per dose costs can be criticized. But this analysis may look very different when put into the context of the value the medicine provides to the patient, and the overall costs incurred by Medicare (or the private insurer) and the patient.

Cost & Clinical Effectiveness Research
Such challenging balances and calculations are what biopharma companies, biomedical researchers, clinicians, insurance companies, government regulators and others struggle with whenever a new treatment is developed for a serious condition. This is the essence of clinical and cost effectiveness research – an area of health policy that is beginning to be much more widely discussed: It has been part of bipartisan Congressional discussions and was highlighted in last year’s Presidential campaign. How the government and others increase their support for this type of research, (i.e. inside government or through some independent or semi-independent agency), how the information from this research is reflected in reimbursement policies, and how clinicians are educated about and use this information, could dramatically improve the quality and value of the health care we all receive for cancer and many other conditions. Only time will tell if that happens, or if too many competing interests snarl up the process with cost savings being put before quality improvement, with the goal of cost containment pushing the information into reimbursement decisions before it is fully analyzed – or as someone once said, trying to get to the dough before the bread is fully baked. (Yeah, I know, very bad dough pun.)

Health Reform and the Economy: 4 Spheres to Consider

Posted on January 25, 2009 by Michael D. Miller MD

Many people and pundits have opined on the effects that the economic downturn will have for the likelihood of health reform: On the Federal level, how much money will be available for expanding insurance coverage, and how much money will be included in the “stimulus package” – and for what? And in the States, how much will be cut from Medicaid programs and government employees’ benefits? In addition, there have been news stories about the economic downturn leading to loss of insurance coverage secondary to job-loss, as well as people forgoing direct medical care, healthy activities, and wellness behaviors.

These points illustrate how the multiple parts of our health care “system” interconnect, (particularly financing effecting delivery), and everything existing within the overall economic environment. [The economy’s effect on healthcare could be similar to how the percentage of oxygen in the earth’s atmosphere effected the development of different plants and animals in different eons.]

While the connection between healthcare delivery and financing is easy to see, research and public health are two additional – and important – spheres that make up our overall healthcare system:

As can be seen in the graphic above, each of the four spheres in our healthcare system interact with the others. While it is obvious that delivery and financing are closely linked, it needs to be remembered that R&D and public health are activities that lead to better quality care, while also being tied to healthcare financing and delivery.

Implications for Health Reform Strategies
These relationships have implications for broad health reform strategies because making changes in one sphere will have effects in the others. For example, not only will expanding insurance coverage for one part of the population – such as children – be a good thing for children, but it will also affect research and development and public health activities related to children. For example, greater insurance coverage can increase incentives for more R&D into vaccines and for their use. But lower payment rates for clinicians to actually provide vaccinations (or higher insurance co-payments) can decrease those incentives. Thus the overall outcome depends upon the balance of effects among the difference spheres.

Resource Limitations
It should also be recognized that resources are limited – both money and people. So, for example, if a big push is made for information technology in healthcare, that will consume money and people, (administrators, researchers, clinicians and policy makers), so that there will be less resources for other areas.

My point is not to say that one issue or problem is more important than the others, but to put some structure around the concept that every action causes other reactions that can be either good or bad, and those possibilities need to be considered in analyzing proposals.

Since most proposals call for relatively small changes, it can also be illuminating to dramatically expand one’s viewpoint. For example, in exploring how to control healthcare spending, the extreme answer to the question, “What is the cheapest way to provide healthcare?” is “Provide no healthcare.” But obviously squeezing both financing and delivery to zero would also have significant undesired consequences in public health (and research), which would certainly not be good for workers’ productivity or the overall economy. Obviously this is one of many examples of the old expression, (and storyline for millennia of parables), “Be careful what you ask for, you may get it. Let’s hope that the consequences of this obvious and old axiom are one of the guiding principles for health reform.

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