Avik Roy Archives


(Cross-posted from The Apothecary on Forbes.com.)

This morning, Democratic Sen. Ron Wyden (Ore.) and Republican Rep. Paul Ryan (Wis.) have shaken up Capitol Hill with an intriguing, bipartisan plan for reforming Medicare, and also the private-sector employer-sponsored insurance system. Politically, the plan is a huge boost to Mitt Romney, whose own remarks on Medicare reform hew closely to Wyden-Ryan; and also to House Republicans, who now have an easy retort to Democrats who were planning to attack Medicare reformers in the 2012 campaign. Substantively, the plan has many encouraging qualities, but there are also some important blanks that Wyden and Ryan will need to fill in.

Premium support with competitive bidding

The heart of the Wyden-Ryan plan is to use competitive bidding to allow private insurers to compete with traditional, 1965-vintage fee-for-service Medicare. If you want to learn more about competitive bidding, see this piece I wrote about Mitt Romney's proposal for Medicare reform. If that doesn't quench your thirst, you can read the definitive book on competitive bidding: Bring Market Prices to Medicare, by Robert Coulam, Roger Feldman, and Bryan Dowd.

The basic idea behind competitive bidding is that, say, on a county-by-county basis, you let private plans and traditional Medicare offer plans with the same actuarial value compete, to see who can offer the same package of benefits the most efficiently. Each plan in a given county will name a price for which they are willing to offer these services, and seniors are free to pick whichever plan they want. However, the government will only subsidize an amount equal to the bid proposed by the second-cheapest plan. If you want a more expensive plan, you have to pay the difference yourself.

As I mentioned in the Romney post linked to above, competitive bidding has some left-of-center fans; indeed, a form of competitive bidding was part of the Senate version of Obamacare. It also has fans on the Right, most notably Yuval Levin, dean of the conservative entitlement-reform wonk set. A key concern I mentioned in the Romney post is that competitive bidding, if not structured correctly, puts private insurers at a disadvantage to the government plan. It would be important to ensure that there is a level playing field between the public and private options under such a system.

The plan would only go into effect for people aged 55 or younger today. These future seniors would buy insurance on a "Medicare Exchange," which would require plans to guarantee coverage regardless of pre-existing conditions, and require plans to charge similar premiums to those who are healthier or sicker.

An unenforceable cap on Medicare spending growth

In the event that competitive bidding failed to bring down spending growth, Wyden-Ryan would cap the growth of Medicare spending to nominal GDP plus one percent (a calculation that includes inflation). How it would enforce this cap is largely unclear. Every Congress is sovereign; one Congress can't bind future Congresses to due its bidding. Hence, if competitive bidding fails to bring costs down (though it should), the Wyden-Ryan approach of requiring Congress to find ways to cut spending is, effectively, toothless.

Implicitly, the Wyden-Ryan approach would repeal IPAB, Medicare's rationing board, without putting any credible mechanism in place for future Congresses to keep costs down.

Means-testing for the wealthy, and protections for low-income retirees

Wyden-Ryan would expand means-testing throughout the Medicare system. Currently, higher-income individuals pay more for Medicare under the program's traditional benefit for outpatient physician services (Part B), and also for the newer prescription-drug benefit (Part D). Under Wyden-Ryan, means-testing would also apply to the premium support payments offered through the Medicare Exchange.

Lower-income individuals who are eligible for both Medicaid and Medicare (the so-called "dual eligibles") would be protected from the GDP+1 spending growth cap.

Medicare Advantage reform

Wyden-Ryan seeks to reform Medicare Advantage in order to drive further spending growth reductions. They note that Medicare Advantage is currently prevented by law from passing on cost savings. "If a private Medicare Advantage plan has lower costs than traditional Medicare, then by law, the plan may not offer a rebate to the senior. Instead, the plan must compete by offering additional benefits, which in some circumstances increases the use of services--and therefore costs."

They're right. And this is why Medicare Advantage has not been able to lower federal Medicare spending. Medicare Advantage plans cost about 14 percent more per person than traditional Medicare plans do, but they typically offer richer benefits than traditional plans. This drives incentives in the wrong direction, and it would appear that Wyden and Ryan aim to change that.

Cost-sharing reform

As I wrote in my big National Affairs piece on Medicare reform, the fundamental problem with Medicare is that seniors are not really required to share in the cost of their care, leading them to spend far more than they need to. Wyden-Ryan urges cost-sharing reforms, though it doesn't make any specific suggestions. Last March, Sens. Tom Coburn (R., Okla.) and Joe Lieberman (I., Conn.) proposed cost-sharing reforms that Wyden and Ryan would do well to consider.

Employer-sponsored insurance reform

One of the most intriguing aspects of the Wyden-Ryan plan is its drive to gradually migrate our inefficient, employer-sponsored private insurance system to a true individual market where people buy health insurance on their own.

Here, Wyden and Ryan are borrowing from Wyden's proposed Free Choice Act, in which employees could choose to opt out of their employer-sponsored plan, and take the money to buy a plan of their own choosing on the private market. The opt-out only applies to workers at firms with 100 or fewer employees. If these workers buy a plan on the open market that costs less than what their employers would have paid for, they can pocket the difference as taxable income.

In the absence of Obamacare, this is a very attractive idea. Instead of simply ending the $300 billion-a-year employer tax exclusion, creating a massive disruption of the private insurance market, the opt-out idea allows for a voluntary, gradual transition to an individual health-insurance market. When people buy insurance for themselves, they are more likely to shop for value, instead of overspending on overly comprehensive benefit packages. That, in turn, brings down costs for the overall system.

Likely what would happen is that healthier individuals would opt out of the system and choose cheaper, consumer-driven health plans that pair high-deductible insurance with health savings accounts. Sicker individuals would stay in the conventional employer-sponsored system. This could, in theory, drive a form of adverse selection, driving up costs for the shrinking pool of sicker beneficiaries. However, the savings from the opt-outs might be worth it.

If Obamacare stays on the books, the opt-out idea could actually cause problems if it wasn't structured the right way. A poorly conceived opt-out, combined with Obamacare's exchanges, could increase the incentives for employers to dump workers onto the subsidized Obamacare exchanges.

Some liberals and conservatives dislike the compromise

As I mentioned in the opening paragraph, Wyden-Ryan means that premium support has now been embraced by a prominent Democrat. This helps inoculate Republicans from the fact-free, demagogic criticism that they are trying to throw granny off of a cliff.

This fact already has Democrats grumbling. "Why in the world [Wyden] agreed to help Ryan get out of the rock he was under is beyond me," a former senior Democratic staffer told Kaiser Health News. "This is a bad move on a couple different levels, and has the potential to take away a key argument for Democrats that are trying to retake the House."

Rep. Pete Stark (D., Calif.) sent out a statement insisting that that the demagoguery would continue. "Despite Wyden's claims otherwise, the Wyden-Ryan plan ends Medicare as we know it, plain and simple."

Some conservatives are unhappy with Paul Ryan, too. Ben Domenech says that Ryan "gave up a lot more to do this [compromise]...My concern is that Ryan's timing and the nature of this plan will be viewed as a walkback, one that weakens the hand of Republicans going into the presidential [election], and creates conflict for his fellow House and Senate members who stuck their necks out to support his budget and now will be confronted by more questions."

Ben is right to raise the concern, but I think it's unlikely to play out that way. Left-wing Democrats are far more likely to take the Pete Stark approach of arguing that there isn't much difference between Ryan's old Path to Prosperity plan and the new Wyden-Ryan one. From the Left's standpoint, anything that moves away from single-payer Medicare is anathema.

Bottom line: A promising plan, but more specifics are needed

While I continue to favor the old Ryan plan (indeed, I'd rather see a true Swiss-style voucher system), I do agree that competitive bidding has certain advantages. Most importantly, it has support on the other side of the aisle. In addition, competitive bidding could drive costs lower in areas where hospital monopolies currently hold sway. This makes it the most plausible, bipartisan approach to Medicare reform that's out there.

On the other hand, it will be important for Wyden and Ryan to help us understand how they will enforce the global spending growth cap. In addition, they will need to explain how their employer insurance opt-out won't explode the Obamacare exchanges (more than they already will be).

One other deficiency in the plan is that it takes too long to work. In order to honor the promise that there will be no Medicare changes for those older than 55, the plan kicks in in 2023. However, Medicare is slated to go bankrupt in 2020 (if you believe the Congressional Budget Office) or 2016 (if you believe the Medicare actuary).

Overall, I'm very encouraged by this plan. It appears that between Ron Wyden, Paul Ryan, and Mitt Romney, a group of prominent political figures is coalescing around a bipartisan approach to Medicare reform. No doubt that the hard-core will find fault with it. And there are technical problems with the proposal that need to be worked out. But we can say that Wyden and Ryan have moved us forward, on the long road to bringing our runaway fiscal problems under control.

UPDATE: There's a lot of commentary on Wyden-Ryan around the web. Ezra Klein speaks for many progressives in arguing that Obamacare's exchanges are similar to Medicare premium support. But what Ezra keeps failing to note is that the direction of reform is different in each case, and also that Obamacare consists of more than just the exchanges.

White House Communications Director Dan Pfeiffer released this statement, bashing the plan, and making an allusion to Newt Gingrich's 1995 comment that competition would make Medicare "wither on the vine."

We are concerned that Wyden-Ryan, like Congressman Ryan's earlier proposal, would undermine, rather than strengthen, Medicare. The Wyden-Ryan scheme could, over time, cause the traditional Medicare program to "wither on the vine" because it would raise premiums, forcing many seniors to leave traditional Medicare and join private plans. And it would shift costs from the government to seniors. At the end of the day, this plan would end Medicare as we know it for millions of seniors. Wyden-Ryan is the wrong way to reform Medicare.

Paul Ryan responds that Obama is "increasingly isolated" from the "growing bipartisan consensus."

I am grateful to have a partner in my friend Senator Wyden, as we work together to create space for bipartisan solutions to address our nation's most pressing challenges. It is disappointing to find the President of the United States increasingly isolated from this growing bipartisan consensus on efforts to save and strengthen our critical health and retirement security programs. The President's failure to offer credible solutions to the challenges facing Medicare is a disservice to seniors, a disservice to hardworking families, and a disservice to the next generation. A more glaring disappointment is the President's failure to recognize a sincere effort by a Democrat and a Republican to come together and offer solutions, betraying his own rhetoric and his own commitment to those we have the privilege to serve. America deserves better.

(Cross-posted from The Apothecary on Forbes.com.)

It's one of the most oft-repeated justifications for socialized medicine: Americans spend more money than other developed countries on health care, but don't live as long. If we would just hop on the European health-care bandwagon, we'd live longer and healthier lives. The only problem is it's not true.

Wealth begets health

Benjamin Disraeli, British Prime Minister under Queen Victoria, once said, "There are three kinds of lies: lies, damned lies, and statistics." Nowhere is this more true than in the debates about health-care policy.

Life expectancy is an appealingly simplistic, but deeply flawed, way to think about the quality of a country's health-care system. After all, shouldn't good health care make you live longer? Well, yes, but. The problem, of course, is that there are many factors that affect life expectancy.

One is wealth. It's gross domestic product per capita, and not health-care policy, that correlates most strongly to life expectancy. Gapminder has produced many colorful charts that shows the strong correlation between wealth and health. Here's one from Lane Kenworthy of the University of Arizona:

Measuring health outcomes at the point of intervention

If you really want to measure health outcomes, the best way to do it is at the point of medical intervention. If you have a heart attack, how long do you live in the U.S. vs. another country? If you're diagnosed with breast cancer? In 2008, a group of investigators conducted a worldwide study of cancer survival rates, called CONCORD. They looked at 5-year survival rates for breast cancer, colon and rectal cancer, and prostate cancer. I compiled their data for the U.S., Canada, Australia, Japan, and western Europe. Guess who came out number one?

U-S-A! U-S-A! What's just as interesting is that Japan, the country that tops the overall life expectancy tables, finished in the middle of the pack on cancer survival.

Car accidents and homicides don't tell us much about health care quality

Another point worth making is that people die for other reasons than health. For example, people die because of car accidents and violent crime. A few years back, Robert Ohsfeldt of Texas A&M and John Schneider of the University of Iowa asked the obvious question: what happens if you remove deaths from fatal injuries from the life expectancy tables? Among the 29 members of the OECD, the U.S. vaults from 19th place to...you guessed it...first. Japan, on the same adjustment, drops from first to ninth.

It's great that the Japanese eat more sushi than we do, and that they settle their arguments more peaceably. But these things don't have anything to do with socialized medicine.

America doesn't have one health care system, but three

Finally, U.S. life-expectancy statistics are skewed by the fact that the U.S. doesn't have one health-care system, but three: Medicaid, Medicare, and private insurance. (A fourth, the Obamacare exchanges, is supposed to go into effect in 2014.) As I have noted in the past, health outcomes for those on government-sponsored insurance are worse than for those on private insurance.

To my knowledge, no one has attempted to segregate U.S. life-expectancy figures by insurance status. But based on the data we have, it's highly likely that those on private insurance have the best life expectancy, with Medicare patients in the middle, and the uninsured and Medicaid at the bottom.

If we look at Switzerland, a country with private-sector, market-based universal coverage, we see very good health outcomes data. Put another way: if we compared the life expectancy of Americans on private insurance with that of centrally-planned Europeans, I'd bet that the U.S. would come out on top. And if that's true, the argument that socialized medicine leads to longer life evaporates.

(This post originally appeared on Avik's Forbes blog, The Apothecary.)

On Friday, FDA Commissioner Margaret Hamburg announced that the agency was revoking its approval of best-selling cancer drug Avastin for breast cancer. This decision is no surprise, coming on the heels of advice from the agency's panel of outside experts last August, which itself was triggered by Genentech's failed phase III trial of Avastin in breast cancer. I continue to fail to understand why conservatives are up in arms over the FDA's decision. If anything, the way FDA has handled Avastin should be a model for future regulatory decisions.

Avastin's FDA history

First, some background. In 2004, the FDA approved Avastin for first-line treatment of patients with metastatic, or malignant, colorectal cancer. The tremendous success of Avastin turned Genentech from a biotech also-ran into the sector's most-valued company. The drug eventually gained additional approvals for second-line metastatic colorectal cancer (2006); first-line non-small cell lung cancer (2006); metastatic HER2-negative breast cancer (2008); second-line glioblastoma, a form of brain cancer (2009); and metastatic renal cell carcinoma, a form of kidney cancer (2009). The drug's mechanism of action--starving tumors of the blood supply they need to grow--proved effective in a wide variety of cancers, and Avastin became one of the most successful cancer drugs in history.

The FDA takes a leap of faith on Avastin

The 2008 approval in breast cancer was based on encouraging results from a 2005 phase III study, the E2100 study sponsored by the Eastern Cooperative Oncology Group. ECOG-E2100 compared Avastin in combination with Taxol (paclitaxel), an older chemotherapy drug, with Taxol alone. While the ECOG study wasn't blinded--patients knew what treatment they were getting--the study showed that patients on the Avastin-plus-Taxol did better on an endpoint called "progression-free survival," which measures how long patients live without a growth in the size of their tumors. Avastin-plus-Taxol patients had a median PFS of 11.3 months, versus 5.8 months for Taxol.

On the basis of ECOG-E2100, the FDA granted "accelerated approval" to Avastin in breast cancer, despite the fact that the trial wasn't up to traditional FDA standards: it wasn't blinded such that doctors wouldn't know which treatment they were giving, and such that patients wouldn't know which treatment they were receiving (what statisticians call double-blinding). In addition, the FDA strongly prefers not to approve drugs on progression-free survival, which is a somewhat soft endpoint, preferring instead to approve a drug on overall survival: the most objective endpoint there is. (Did you live, or die, after taking the drug?)

The FDA's accelerated approval of Avastin was conditioned on Genentech conducting a proper, double-blinded study comparing Avastin to the standard of care. The study would need to show that patients on Avastin lived longer than those who weren't on Avastin.

The FDA's decision aids biomedical innovation

In other words, the FDA did exactly what I and other FDA-watchers are always asking the agency to do: get drugs out there quickly, put them in the hands of doctors and patients, and let the clinical evidence pile up over time.

The FDA only pulled its approval of Avastin for breast cancer after that blinded phase III trial was finished, a trial that showed that patients on Avastin didn't live longer than those not on it. Because Avastin is already approved for other diseases, doctors are free to prescribe it "off-label" for breast cancer if they want to. Medicare has promised that they will continue to pay for it, even though it's debatable as to whether or not they should.

The Wall Street Journal, and others, have denounced the FDA's move as "a chillingly blunt assertion of regulatory power." But Paul Howard is the guy who gets it right:

If you think (as I do) that the FDA should be expanding the accelerated approval pathway and allow more drugs to get to market based on promising early studies. rather than waiting for large Phase III clinical trials that can take years to complete, you can argue that this outcome actually strengthens AA. Critics have charged that AA is sop to industry, and that companies never do the follow up studies to support AA. Avastin proves them wrong.

This is exactly the point. If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren't as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see the FDA handle more cases like this one, not less.

In February, it looked like the field of developing drugs for obesity was dead. The FDA had rejected its fourth recent late-stage candidate for weight-loss therapy--Orexigen's Contrave--which led my Forbes colleague Matt Herper to declare, "The clear lesson is that weight-loss medicines simply do not have enough of a benefit to justify any risk--and that this makes getting them approved almost impossible."

Well, one of the small companies involved in this space--California-based Vivus--is trying again. Vivus' drug, Qnexa, had been rejected by the FDA a year ago, due to concerns that its two previously-approved components could increase risk of cardiovascular complications, and that one of those components--topiramate--could cause birth defects.

In the third quarter of 2011, Vivus resubmitted their New Drug Application to the FDA, this time specifying that the drug should only be used in men, women over 55 years of age, and sterile women under 55. Bank of America's Steve Byrne believes that these three groups comprise "roughly two-thirds of patients seeking weight loss drug treatment."

In addition, the company is conducting a retrospective analysis of insurance claims for women who have taken low-dose topiramate for the treatment of migraines, to see if any of those patients had children who suffered from birth defects. If that study, called FORTRESS, works out, the entire market could become available to Vivus.

But that would require the FDA's assent, and it's simply not clear if the FDA wants to approve any obesity drugs. Instead of taking this risk-averse approach, in which companies spend hundreds of millions of dollars on large clinical trials, only to get swatted down by a risk-averse government agency, there is another way: allowing companies to get on the market after mid-stage phase II trials, but with significant restrictions.

This would allow companies like Vivus to market their drugs to a narrow population, generating needed revenues and funding important research, while allowing the FDA to gain real-world experience with a drug's benefits and risks. The Biotechnology Industry Organization has come up with one such proposal, in which the FDA expands its program for approving drugs in earlier stages of development (progressive approval). I'll have more to say on that subject later this week.

Vivus should find out the FDA's final decision by mid-April of next year. But, under a progressive-approval system, Qnexa could have been on the market three or four years ago. It's time to think about how we can reorient the FDA towards innovation.


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