Author: Jacob Goldstein

Last year saw big changes at the FDA — starting at the top with a new commissioner, appointed by a new administration — but you wouldn’t know it from looking at the number of drugs the agency approved.

The Obama-era FDA approved 26 new drugs last year. That’s a hair’s breadth from the 25 new drugs approved by the Bush-era FDA in 2008, according to figures out today from Washington Analysis, a research shop whose customers are institutional investors.

Of course, the drug approval process is a long one, and changes put in place last year may take a while to play out. Ira Loss, a senior health policy analyst at Washington Analysis, suggested that a recent increase in funding for the agency could speed up the decision-making process.

Companies “are going to have a better experience trying to get to the end of the line,” Loss told us when we got him on the phone this afternoon. “Better funding of the agency is going to mean that there are fewer delays.”

The FDA approved seven biotech drugs and 19 traditional (i.e. small molecule) drugs last year. While the number of small-molecule drugs approved was comparable to the figures from recent years, the number of biotech drug approvals was up from two in 2007 and four in 2008.

If we were in an expansive mood, we might suggest that the increase reflects big pharma’s big push into biotech. But maybe the numbers are just a blip. After we got off the phone with Loss, we emailed him to ask what he thought. Here’s his reply:

I think it has the potential to be a breakout, but I am not prepared to say so based on one year. If there is a repeat performance in 2010 then I would be prepared to say the long awaited breakthrough in therapeutic biotech approvals may in fact be here. But not yet!

The FDA expects to report its number of 2009 drug approvals by Friday, but the agency reported 25 new drugs approved as of Dec. 1, according to the Associated Press. You can search the FDA’s reports on drug approvals here.

Bonus Approval: Take a walk through 2009 with the Health Blog. Read our posts on some of last year’s new drugs: Multaq from Sanofi-Aventis, Effient from Eli Lilly and Daiichi Sankyo, Simponi from J&J and Onglyza from Bristol-Myers Squibb and AstraZeneca. For more on some of last year’s key approvals (and delays), see this story from Dow Jones Newswires.

If, like a kid after summer vacation, you’ve forgotten everything you learned before the holiday break, allow us to suggest a quick re-entry to the health-care debate.

It’s time for the House and Senate to hash out the (substantial) differences between the bills they’ve passed. And while it’s pretty clear that the House is going to have to do most of the giving in order to get a final bill through the Senate. The new, government-backed plan that’s included in the House bill, for example, will be DOA in the Senate.

There might be a little more wiggle room on how to pay for expanded health coverage; for example, Politico says, the House might lean on the Senate to raise the threshold for the tax on high-end health insurance plans, which unions don’t like. Differences over how the bills restrict funding for abortions may be particularly tough to resonve, the WSJ has said.

If you really want to know what’s what, it’s worth taking a closer look at the differences between the bills. This WSJ story is a good jumping off point; if you want to go deeper, take a look at this table compiled by House staffers and posted by Politico, or this 24-page takeout from the Kaiser Family Foundation.

Bonus Process: A couple other wonky details: The House and Senate are going to try to work out a final bill without using a formal conference committee. Here’s why. Also, C-Span wants to broadcast the House-Senate negotiations, which are expected to take place largely in private.

Photo: Associated Press

The headline on that health-spending report in the news today is “Health-Spending Growth at a Historic Low in 2008.” That’s true as far as it goes — growth increased at a rate of 4.4%, the slowest rate in the past 48 years.

But an arguably more important figure to keep an eye on is national health-care spending as a percentage of total GDP. If health-care spending rose at the same rate as GDP, we could leave the current system in place and be fine (at least in a macroeconomic sense). But because health-care spending is rising faster than GDP, we are spending an ever-larger portion of our national income on health care.

So what happened with health-care spending as a percentage of total GDP in 2008? Not only did it rise — it rose at a faster rate than in recent years. In 2005, health-care spending accounted for 15.7% of GDP. It rose to 15.8% in 2006, and 15.9% in 2007. Then, in 2008, it jumped to 16.2% of GDP.

That happened because, even though the growth of health-care spending slowed in 2008, overall GDP growth slowed a lot more. This is typical during economic downturns: The paper notes that “larger increases in the health spending share of GDP generally occur during or just after periods of economic recession.” (The authors are based at CMS, the government agency that runs Medicare and Medicaid.)

This makes sense on an intuitive level, because people may keep paying for health care even when they cut back on other spending. What’s more, the federal government — always a big payer via Medicare and Medicaid — upped its contribution as well. Federal spending for health services and supplies grew sharply in 2008, up 10.4%, according to the paper, which was published in the journal Health Affairs.

One final note: Most of the increase in 2008 was due to higher prices, not due to population growth or more use of health-care service, according to the analysis.

Image: iStockphoto

The American Academy of Pediatrics is on the fence about circumcision for newborn boys: The group says there’s not enough evidence to recommend routine circumcision, and parents should weigh the risks and benefits of the procedure.

But a group of doctors from Johns Hopkins and the NIH argue this week in the Archives of Pediatrics & Adolescent Medicine that the AAP should update its recommendation because recent studies showed circumcision reduces the risk of catching certain sexually transmitted diseases. Some key recent data come from African men who were circumcised as adults, but the authors argue that observational evidence shows the procedure also lowers risks for U.S. men who are circumcised as infants.

Parents should still be allowed to decide what’s best for their baby, the paper argues. But a stronger stance by the AAP might lead to broader coverage of the procedure by state Medicaid programs, the health-insurance program for the poor. That could drive up circumcision rates among the poor and, ultimately, drive down the rate of sexually transmitted infections.

An accompanying editorial argues that the data on health benefits are “not yet clear enough” to recommend routine circumcision — but agrees that there’s enough evidence to merit Medicaid coverage for those parents who choose circumcision.

There are 16 states where Medicaid doesn’t cover the procedure, according to the Hopkins and NIH docs.

We wanted to hear what the AAP had to say about the subject. The group’s press office directed us to a doc who serves on the group’s circumcision task force, but we haven’t heard back from him yet. We’ll update this post when we do.

For further reading on the risks and benefits of the procedure, check out this patient information page that Archives published along with today’s papers.

Update: The AAP’s task force has been reviewing the evidence on circumcision for more than a year, according to Doug Diekema, a Seattle doc who is part of the group. The task force expects to publish an updated policy later this year; they’re unlikely to recommend that all newborn boys be circumcised, Diekema said.

“I think probably … we are going to say something similar to what we said the last time which is, ‘There are potential benefits. There are also some risks. And parents ought to be informed of those things and given the choice.’ ”

Image: iStockphoto

Scrutiny of financial ties between drug companies and doctors, all the rage in the U.S. these days, has spread to India.

The Medical Council of India, the group that sets the standards for the nation’s doctors, recently updated its ethics rules to bar doctors from accepting “any gift from any pharmaceutical or allied health care industry and their sales people or representatives.” That includes payment for transportation or accommodation, the rules say. (The updated rules are described at the bottom of this page.)

But a story from India’s Business Standard says the rules may not have much of an effect because they’re not accompanied by penalties. “We need to develop mechanisms so that a variety of transgressions are regulated and penalised,” the president of the Public Health Foundation of India told the paper.

Still, the new rules suggest a shift in norms, the vice president of the Indian Medical Association told the Times of India. “The amendments will pave the way to have a control over such unethical practices,” he said. “Even as the immediate impact of the amendment cannot be judged, inclusion of the issue in ethics regulation will help control such activities.”

Hat Tip: Pharmalot; Image: iStockphoto

Novartis said today that it’s looking to buy out the balance of Alcon, the big eye-care company. Novartis already has a 25% stake, and if the deal goes through as announced, Novartis will have invested about $50 billion to acquire all of Alcon.

Given Alcon’s prominent place in the contact lens aisle of your neighborhood pharmacy, it’s tempting to label this deal as a drug-maker’s bid to get into the consumer-health business — like Sanofi-Aventis’s recent (much smaller) agreement to buy Chattem, maker of Gold Bond powder and Selsun Blue shampoo.

But take a look at Alcon’s recent quarterly report and you’ll see that consumer products accounted for only about 13% of the company’s sales. The company makes most of its money from prescription drugs (particularly those used to treat glaucoma and infection of the eyes) and surgical products (with an especially strong business in treating cataracts).

So what Novartis is really buying its way into here is a specialty-care company with a strong foothold in eye doctors’ offices. Alcon’s businesses are likely to grow both as the population in the developed world ages (advanced age is a risk factor for both cataracts and glaucoma) and as income rises in the developing world, allowing more people to pay for treatments like cataract surgery.

Dow Jones Newswires has more on the details about the proposed deal.

Sorry, one more New Year’s story to get out of the way: Top doctors at Mass. General and Brigham & Women’s — two of the most prestigious hospitals in the country — have to limit their financial ties to the drug and device industries under rules that kicked in on the first of the year.

When senior physicians at the hospitals serve as directors on corporate boards, they will no longer be allowed to accept payment in the form of stock or stock options. But they may be paid up to $5,000 per day ($500 per hour) for the work they do as corporate directors. The Boston Globe and New York Times detailed the rules in stories this weekend.

As we noted back in April, when the hospitals announced many of the new rules, doctors at the facilities will no longer be allowed to serve as paid speakers for companies — often a lucrative gig for high-profile docs.

Both hospitals are part of Partners HealthCare, a Boston-based health system, and both are affiliated with Harvard Med School.

Lots of big-name health-care institutions are trying to limit docs’ industry ties — or at least to be more transparent about the relationships that do exist. Johns Hopkins tightened its conflict-of-interest policy last year, and Stanford, Northwestern and the Cleveland Clinic all said they’d start disclosing which of their docs had financial ties to drug and device companies.

Industry has been moving in the same direction, with Pfizer, Eli Lilly, Merck and Medtronic, among others, beginning to disclose some payments to docs. And in Congress, Chuck Grassley and a few other lawmakers have been pushing for a federal law requiring this kind of reporting; the latest version is on p. 1542 of the Senate health-care bill.

Photo: iStockphoto

About 3,000 Medicare patients who’ve been getting care at a Mayo Clinic facility in Arizona will have to pay out of their own pocket or find another doctor.

Starting in 2010 (i.e., next week), the five primary care docs at a Mayo outpost in Glendale, Ariz. will stop accepting Medicare. Patients in the program who choose to stick around will be on the hook for about $1,500 per year, Mayo spokesman Michael Yardley told the Health Blog. The clinic expects that most of the patients will find another place to get their primary care.

“We know it’s been incredibly difficult for our patients,” Yardley said.

Medicare typically pays doctors lower rates than private insurance companies. That makes some docs reluctant to accept Medicare patients, and can sometimes make it hard for Medicare patients to find primary care. Medicare covers about half the cost of a primary care visit at Mayo, while private insurance typically covers the whole cost, according to Yardley.

The new Medicare policy applies only to the Glendale facility, but it eventually could be expanded to other sites where Mayo provides primary care. Hospitalization and specialty care won’t be affected.

Mayo — which has been cited by President Obama as a model of high quality care at a reasonable price — is based in Minnesota (of course), but it also has a pretty big operation in Arizona.

For further reading, see the Arizona Republic and Bloomberg News.

Image: iStockphoto

Back in September, the Congressional Budget Office raised its estimate of how much money the feds would save if tort law were changed to reduce liability for doctors and hospitals.

Even the new, higher estimates don’t suggest that tort changes (such as capping noneconomic damages) would be a silver bullet for health costs; CBO says the changes would lower the nation’s health-care bill by about 0.5%, and reduce the feds’ burden by $54 billion over 10 years.

Still, a few lawmakers have asked CBO to elaborate on its new estimates. Earlier CBO letters answered questions from Sens. Rockefeller and Hatch. The latest response came earlier this week, in a letter to Rep. Bruce Braley of Iowa who, NPR’s Shots blog notes, once headed Iowa’s association of trial lawyers.

This week’s letter touches on links between tort changes and several subjects, including:

Malpractice premiums. CBO cites several studies that found that, over the long run, premiums decline when changes to tort law lower medical liability.

Patient health. Does changing tort law to reduce medical liability lead to worse outcomes for patients? The evidence on that question is mixed, and the answer isn’t clear, CBO says.

Defensive medicine. Recent studies have solidified the evidence that tort changes can alter patterns of medical practice and “slightly reduce the use of health care,” CBO says. The authors don’t use the term “defensive medicine,” but that’s what they’re talking about.

Image: iStockphoto

Public-health-related bans are set to take effect with the New Year in a bunch of states. Here’s a sampling:

California restaurants will be banned from using trans fats. Starting tomorrow, restaurants won’t be able to use “oil, shortening, or margarine containing specified trans fats,” according to the text of the legislation. In 2011, the bill will expand to prohibit restaurants from serving “any food containing artificial trans fat.” Certain exceptions will apply, and some school cafeterias will be exempt. Eating trans fats increases the risk of heart disease, stroke and diabetes. California is the first state to ban restaurants’ use of trans fats, the San Francisco Chronicle says, though some cities (including New York) have similar bans in place.

Smoking will be banned in North Carolina bars and restaurants starting Saturday. Yes, dozens of states already have smoking bans in place. But this one’s noteworthy because North Carolina is a big tobacco state, and home to cigarette giants like R.J. Reynolds (Camel, Winston) and Lorillard (Kent, Newport). “Even as recently as a decade ago, this was unthinkable,” a UNC prof told the Charlotte Observer.

Texting while driving will be banned in New Hampshire, Oregon and Illinois, the Associated Press reports. That will bring the number of states that ban the practice to 19, according to the Governors Highway Safety Association, which publishes this handy chart of state laws that limit the use of cell phones while driving.

Astonishingly, the AP found a 42-year-old woman who said for the record that she didn’t plan to stop texting while driving in New Hampshire, where the fine for getting caught will be $100. “I’d better start saving my money,” she told the AP.

Photo by GypsyRock via Flickr

Most pregnant women wind up taking at least one prescription drug. But, because no one wants to subject pregnant women and their unborn children to a clinical trial, there’s very little clear evidence about the unique risks some prescription drugs may pose during pregnancy.

So the FDA is funding an analysis of data on prescription drug use and pregnancy outcomes from a bunch of health systems that collectively recorded roughly one million births between 2001 and 2007. Researchers from Harvard, Vanderbilt and Kaiser Permanente, among others, will work on the project.

In the current system, women and their doctors rely in part on letters the FDA assigns to prescription drugs as a shorthand for what is known about a drug’s effect on pregnant women and their babies. The letters are explained here. A 2004 study published in the American Journal of Obstetrics and Gynecology found that more than a third of pregnant women take prescription drugs from category C, which means the effects on human fetuses are unknown.

The FDA described the new reserach project in a statement yesterday, but didn’t say when it expects results from the analysis.

Hat Tip: Pharmalot; Image: iStockphoto

The stimulus bill that Congress passed back in February said docs and hospitals that make “meaningful use” of electronic medical records would get big bonus payments from Medicare and Medicaid. The bill laid out a few basics about meaningful use — reporting quality measures, sharing information electronically — but didn’t get into much detail.

The feds released plenty of details late today, in this 556-page proposed rule that lays out what doctors (a.k.a. “eligible professionals”) and hospitals will have to do to qualify for the money.

On the off chance that you don’t have the time or interest to read 556 pages, we suggest you skip to Table 2 on p. 103, which lists the criteria docs and hospitals will have to meet in the first phase of the roll-out.

The stuff there is largely what the people we talked to were expecting. Among the requirements: File prescriptions and submit insurance claims electronically; give patients electronic access to their health information; use computerized systems to enter at least some of doctors’ and nurses’ orders; track patients’ medications electronically; and record vital signs and lab test results electronically.

Sharing electronic information between different medical practices and hospitals isn’t something that happens very often; the meaningful use guidelines seem to recognize this. When the program kicks in, in fiscal year 2011, doctors and hospitals only need to say that they “performed at least one test” of their system’s ability to “electronically exchange key clinical information.”

Mike Valentine, EVP of the health records company Cerner, told the Health Blog that “they’re setting a much lower bar for interoperability and sharing” information, and a somewhat higher bar for the way docs and hospitals use electronic systems internally.

The stimulus bill specified that incentive payments — which can top more than $40,000 for a single doctor over several years and could total more than $20 billion nationwide (see p. 449) — would be tied to meaningful use of certified systems. Now that there’s some clarification on meaningful use, one key question remains about certification: Just who is going to do it?

The feds did release this proposed rule today regarding certification criteria. But Scott Decker, president of the EMR shop NextGen, pointed out to us that it’s still not clear what body will be doing the certifying.

There is an existing certification group, but the feds haven’t said for sure whether that group will be the key for getting a stimulus-ready system. “The lack of a certification body at this stage is a problem,” Decker said.

The proposed rules are, like the Health Blog, open for public comment. Final rules are expected next year.

Image: iStockphoto

Lots of big drug makers have been pushing into China lately. Eli Lilly’s adding jobs there even as it makes cuts in the U.S.; Novartis is spending $1 billion to expand an R&D facility in Shanghai; and Pfizer has made a couple deals to study and sell drugs in China.

But at least one drug maker is moving in the other direction: Ranbaxy, the big Indian generics shop, said it’s getting out of a joint venture with a state-owned company to manufacture drugs in China. The partnership, established 16 years ago, was one of the first Sino-Indian joint ventures, the Financial Times notes.

Ranbaxy will still sell drugs in China, but the company is consolidating manufacturing as part of a series of cost-cutting measures. The company has also cut staff in some markets, Dow Jones Newswires says.

Last year, the Japanese drug maker Daiichi Sankyo bought a controlling share in Ranbaxy, shortly before Ranbaxy ran into trouble with the FDA. Daiichi Sankyo took a write-down of nearly $4 billion on the deal.

Map: iStockphoto

You’re the CEO of a little company with a promising experimental antibiotic. You cut a deal with J&J to co-develop your new drug. Sweet deal! Unless …

Unless, when the drug is submitted for FDA approval, the agency balks. Unless the FDA tells J&J there wasn’t adequate monitoring of the clinical investigators’ conduct of late-stage trials, and key data are unreliable.

That’s what Basilea, a Swiss drug maker, says happened with ceftobiprole, an antibiotic that was just rejected by the FDA.

The news wasn’t much of a surprise, given that the agency had already said it found problems with the way the studies were conducted. In fact, Basilea has already taken J&J to arbitration over the problems.

In its statement today, Basilea says J&J breached the licensing agreement between the two companies by “among other things, causing the delay in the approval of ceftobiprole in the U.S. and EU. Basilea’s initial significant damage claims, including milestone payments and additional damages, in the arbitration will increase as a result of this further delay.”

In a statement cited by Dow Jones Newswires, J&J said it planned to discuss “the best way forward” with the FDA as soon as possible. Earlier this year, a J&J spokesman told the Health Blog that the company was prepared to arbitrate Basilea’s dispute, and added that the companies “share a goal to get the drug to patients.”

Image: iStockphoto

Sounds like the FDA is about to get tougher on new medical devices: The acting director of the agency’s device division tells the WSJ and New York Times that stricter criteria for approval are on the way.

His comments come as a couple new journal articles suggest many devices are approved based on studies that lack rigor.

One article, published in JAMA, looked at cardiovascular devices that were approved by the FDA between 2000 and 2007 and were subject to the agency’s most stringent level of scrutiny for devices. Most of the approvals were based on a single study. Less than a third of the studies were randomized. And only about half of the primary measures in the studies were compared with outcomes from control groups. The authors, based at UC San Francisco, found that FDA approval was “often based on studies that lack adequate strength and may be prone to bias.”

The other article, published in the American Journal of Therapeutics, also looked at the approval of cardiovascular devices subject to a high level of scrutiny. In 40% of the studies used as the basis for FDA approval, key safety measures weren’t “high quality,” according to that paper, which was co-authored by an FDA scientist. In 18% of the studies, key measures of effectiveness weren’t high quality, the article found.

An official at AdvaMed, the device industry trade group, told the WSJ that the FDA spends 1,200 hours reviewing each device application, and companies submit large amounts of data before approval is granted. The official also said that the authors of the JAMA study didn’t have access to all of the data companies submitted to the FDA.

The FDA may soon start pushing drug makers to use more sharply defined targets to measure success, follow patients more closely and work more closely with the agency in setting study goals, according to the WSJ and NYT.

Photo by CarbonNYC via Flickr

Medical research is finally starting to catch up with millions of Americans who have been taking vitamins and supplements for years. But people who swear by their pills to stay fit and sharp may not like the evidence that’s starting to accumulate.

The latest comes from a federally funded study of ginkgo biloba, a supplement widely used to improve memory and other cognitive functions. More than 3,000 people between the ages of 72 and 96 were randomly assigned to take a placebo or 120 mg of ginkgo twice a day. None of the patients had dementia when the study began, and they were followed for a median of just over six years.

Those who took ginkgo fared no better than those who took placebo on a battery of tests that examined memory, language, attention and other measures of cognitive function. The results are published in this week’s JAMA; an earlier analysis of the same study also found that ginkgo didn’t reduce the risk of Alzheimer’s.

As this New York Times column noted earlier this year, several big studies in the past few years have suggested that certain vitamins pills and other supplements don’t improve key health outcomes.

“I’m puzzled why the public in general ignores the results of well-done trials,” one doc who has studied this stuff told the NYT. “The public’s belief in the benefits of vitamins and nutrients is not supported by the available scientific data.”

Image: iStockphoto

Sure, there was a logic to Sanofi’s $1.9 billion acquisition of Chattem. As we noted a few days back, it’s the latest example of a big drug company looking to diversify into the more stable consumer products business.

But a couple of investors may have had a bit more insight into the deal than that, the SEC alleged this week.

The agency said it obtained an emergency asset freeze against two men who had “possession of material, nonpublic information” about the deal and who bought options on Chattem stock earlier this month. The men sold the options, which were set to expire on Jan. 15, immediately after the deal was announced this week. The trade brought the men, who are French and live in Brussels, “illicit profits” of $4.2 million, the SEC said.

Bloomberg and Reuters said the men couldn’t be reached for comment.

The SEC has recently been looking at other big health-care deals as well. A broad probe of insider trading included investigations of the Pfizer-Wyeth and Merck-Schering deals as well, the WSJ reported recently. None of the companies has been accused of doing anything wrong.

Image via Chattem

The Senate’s vote on the health-care bill this morning set off an avalanche of responses from key interest groups. The short version: The AMA, drug industry and AARP backed the bill; health insurers and the Chamber of Commerce did not.

Here are some highlights culled from our inbox; links to the complete statements are included for the statements we could find online.

AHIP, the health insurance trade group:

Health plans support legislative changes that would provide guaranteed access to all Americans, with no pre-existing condition limitations and no health-status-based premiums. … At the same time, specific provisions in this legislation will increase, rather than decrease, health care costs; reduce coverage options; and disrupt existing coverage for families, seniors and small businesses – particularly between now and when the legislation is fully implemented in 2014.

AMA:

The AMA supported passage of the bill because it contains a number of key improvements for our health care system, which currently is not working for far too many patients or the physicians who dedicate their lives to patient care. Important issues that need to be resolved in the House-Senate conference committee include the scope, authority, accountability and transparency of a payment advisory board. The details of several cost control and quality improvement initiatives also need to be refined so that they do not have unintended consequences for patients and physicians. (full statement)

PhRMA, the drug industry trade group:

In the final analysis, we believe the Senate bill provides the best blueprint for reform. It offers the kind of change that will benefit patients today without putting medical progress at risk in the future. Today, we believe the Senate voted with America’s best interests and future in mind. (full statement)

AdvaMed, the medical device trade group:

The tax on medical devices and diagnostics present significant challenges for our industry, but we are committed to working constructively on a number of important refinements to implementation. These include a start date of 2013 to allow companies reasonable time to prepare for the tax, protections for small companies, and ensuring that the tax is deductible.

AARP:

The bill passed by the Senate makes needed progress to prevent coverage denials due to health status and limit insurance companies from charging older Americans much more for coverage because of their age. It also begins to close the dangerous gap in Medicare drug coverage known as the doughnut hole, and Senate leaders have committed that a final bill will close the gap entirely by 2019, in keeping with the President’s pledge. (full statement)

U.S. Chamber of Commerce:

The business community has been consistent in calling for health care reform, but the bill that was passed by the Senate today is counterproductive, does little to lower the cost of health care, and it is not reform. It implements crippling new taxes, and hurts our ability to create jobs at the worst possible time for the economy. (full statement)

Image: iStockphoto

The Senate just passed its version of the health-care bill by a vote of 60-39. Over the next month or so, the Senate and House will try to work out the differences between the bills.

Here’s a quick overview of some of the key effects of the Senate bill, based on estimates from CBO and the Joint Committee on Taxation for the years 2010-2019.

$395 billion in federal spending to expand the number of people covered by Medicaid and CHIP, insurance programs for the poor.

$436 billion in federal spending pay for health-insurance exchanges that would largely be used by people who don’t get health insurance through work. Most of that money would be in the form of subsidies for insurance premiums for people earning up to four times the poverty level.

$398 billion in new taxes. That includes the tax on high-value health-insurance plans, new fees on health insurers and drug and device makers, and higher payroll taxes for high earners.

$483 billion in cuts to projected spending for Medicare and other programs. This includes reductions in projected costs for privately administered Medicare Advantage programs and a new formula likely to lower annual increases in payments to hospitals.

31 million additional people would have health insurance by 2019 because of the bill.

23 million people in this country would still be uninsured.

The smart money has been saying this week that the final health-care legislation will look a lot like the Senate bill that is very likely to pass tomorrow with 60 votes.

But there could still be a month or more of hollering left before all is said and done. The standard line has been that House and Senate Dems will reconcile their health bills before the president delivers the State of the Union address, which is typically given in late January. But Politico reports today that the haggling may take longer than that.

Even assuming that House Dems gives up on a public option — which they’ll have to do, if they want a bill that can pass the Senate — there will be several other bones of contention. Backers of both bills say they maintain a prohibition on using public money to pay for abortions — but the bills differ on how they treat the issue, and reconciling the two could prove difficult, the Associated Press reports.

Another big difference between the bills is how to pay for expanding the number of people with health insurance. The House bill relies heavily on a surtax on people with high incomes, while the Senate bill includes a payroll tax increase and a tax on high-end health insurance plans, as yesterday’s WSJ noted. (President Obama backed the tax on high-end health plans in an interview with NPR today, by the way.)

Assuming the a bill does clear Congress early and get signed into law at some point in the next month or two, it will be several years before all of the changes are phased in. We figure the debate may wrap up some time in 2019, give or take.

Photo: Associated Press