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The Office of Personnel Management (OPM) is planning a new database that will store health care claims information from three federal programs - the Federal Employees Health Benefits Program, the National Pre-Existing Condition Insurance Program and the forthcoming Multi-State Option Plan.
OPM (in a 10/5 Federal Register notice, says the database will allow OPM to "actively manage all three programs to ensure the best value for the enrollees and taxpayers." The database will be effective Nov. 15 "unless comments are received that would result in a contrary determination."
OPM? Healthcare “value?” This raises two issues: (1) expertise and (2) mission creep. Are people being hired to do this? Who are they? Who’s choosing them? Transparency is required – if not a Congressional hearing.
Information collected will include personal identifying information, address, dependent information, employment information, health care provider details including debarred provider information, health care coverage information, health care diagnosis information and provider changes and reimbursement on the aforementioned coverage, procedures and diagnosis.
OPM? Really? Sounds like a CMS program – or even AHRQ. Also, will this data be shared with other federal agencies? And if so, to what end.
Per the FR notice, "the data will be de-identified for specific analysis that provide flexible queries of the data set for general demographic queries, risk-adjusted profiles, and comparison of chronically ill patients and other useful analytics; and engage in econometric modeling of, among other things, health trends, risk adjustment methodologies, pharmacy pricing and negotiation."
Hm – “econometric modeling?” That sounds menacing.
Yes – definitely Congressional hearing material.
So if you want to claim just the opposite: that spending on health care is not related to life expectancy or want to show that the US healthcare system needs to control costs by allowing the government to "coordinate care?"
You do what Sherry Glied and Peter Muening did in their widely publicized article in Health Affairs, "What Changes In Survival Rates Tell Us About US Health Care". You come up with a 15 year survival rate which understates the effect of treatment since most studies track 5 year survival rates after diagnosis and treatment and overstate behavioral issues. Then you simply assert -- because there is more spending in the US than Europe -- that the difference is the result of our lousy, inefficient system of care.
content.healthaffairs.org/cgi/content/full/hlthaff.2010.0073v1#SEC1
How do the authors get away from making the exact obvious conclusion that the rest of the epidemiological literature has shown? One reason is that Health Affairs is carrying a torch for Obamacare and whatever peer review took place was passive or unconcsious. Another reason: such statistical skewing is easy to get away with because most in the media simply report the conclusion without looking at the methods.
The authors state: "We measured fifteen-year survival rather than life expectancy because the latter can be biased by the survival experiences of a small number of elderly people, among whom coding errors are common. Focusing on survival also allowed us to distinguish between the experiences of specific cohorts. We explored fifteen-year survival for men and women separately because risk-factor profiles differ greatly by sex and country.
By looking at overall survival after 15 years the authors can go back to a time when medical innovations essential to survival by disease were non-existent but detection in the US was more prevalent The effect of higher levels of detection -- in the absence of innovations -- are what appears to be lower rates of survival. At the same time they ignore mortality rates because the US had a faster decline in mortality from major diseases (many of which Glied and Muenning ignore) than in other countries.
This hatchet job has yet to be questioned by anyone in the media. If anyone is interested they can compare the Health Affairs j'accuse with other studies that are less biased. In particular, look at Low Life Expectancy in the United States: Is the Health Care System at
Fault? by Samuel H. Preston and Jessica Y. Hoy of UPenn.
repository.upenn.edu/cgi/viewcontent.cgi
Been warning about this from the very beginning, and now it’s starting in earnest: Cost-centric strategies leaving patient-focused medicine in the dust.
Last week the Medicare Payment Advisory Commission met to consider recommendations that empower Medicare to reinstate the option to base Part B drug reimbursement on the least costly alternative (LCA) among products.
Note please, that “least costly” in no way means “best for the patient.”
On October 7th, MedPAC heard two proposals outlined by commission staffer Nancy Ray.
The first was that Congress should give CMS authority to apply least costly alternative policies in setting payments for items and services covered under Medicare Parts A and B, and CMS should periodically assess the clinical similarity of Medicare-covered services and apply LCA policies for those services deemed clinically similar.
The second was that Congress should direct CMS to set the payment rate for a newly covered service that lacks evidence demonstrating better outcomes than existing treatment options at a level that is no higher than the LCA.
The policy could end up relying heavily on data from comparative effectiveness research conducted under the auspices of the Patient-Centered Outcomes Research Institute, which is being created under the Affordable Care Act.
A provision of the ACA states that HHS cannot deny coverage of items based solely on the results of comparative clinical effectiveness research, presenting a possible gray area should LCA determinations favor one product over another.
Ray predicted that both of the LCA recommendations would decrease spending relative to current law and also would lower beneficiary cost sharing in the short term and Medicare premiums in the long term.
While the commission did not vote on either recommendation, comments from members were generally supportive. Surprised?
If you needed another reason to understand why the upcoming elections are so crucial to 21st century patient care – you’re welcome.
You can see the first evidence of Obamacare repeal by Obamacare here:
www.hhs.gov/ociio/regulations/patient/appapps.html
Who "lost" medical technology?
At an FDA-sponsored public meeting in Irvine, California, CDRH Director Jeff Shuren shared that new regulations for approving medical devices may include a new category for medium-risk products. Products in this category would require more studies on safety to win agency clearance. According to Shuren, changes will be phased in and that changing the rules may not result in more studies being required of device makers initially. “We are still addressing that on a case-by-case basis where it’s appropriate and necessary, he said.
Is more data always better? Sometimes. But how does this weigh against the growing “device gap” between the US and the EU? It seems that what’s old is new again – and not necessarily for the better.
When the agency determines it needs more data for an approval or that a device application should fall under a new designation, consideration must also be given to what’s going on “over there.” We cannot and must not create a regulatory environment for medical technology (or, for that matter, pharmaceuticals) that exists in isolation from the rest of the world. Harmonization mustn’t mean “do it our way,’ but rather, “let’s talk.”
It even discusses the need for collaboration:
Support for mission-critical applied research, both at FDA and collaboratively
Support within the FDA is critical to expanding the field of regulatory science. An active research program, directly connected to the FDA review process, will not only bring needed advances in regulatory science straight to FDA review, product development, and evaluation but will also add value to guidance and policy development.
In addition, the discipline of regulatory science must be developed though support from both partnerships and external research and collaboration. There are substantial opportunities to enhance and expand current FDA programs and to develop new ones that support effective, more robust, external and collaborative efforts to advance regulatory science. Some projects are already under way:
• A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science through enhanced scientific collaboration and jointly supported and administered extramural research grants in regulatory science.
• Creation and support of academic Centers of Excellence in Regulatory Science to carry out applied regulatory science research both independently and in collaboration with the FDA and as a locus for scientific exchange and training opportunities for both FDA and academic scientists
• Enhanced strategic collaboration and coordination with other governmental agencies to develop new programs to advance regulatory science and innovation
• Enhanced support and focus for the Critical Path Initiative to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process
• Partnership with the Reagan-Udall Foundation on projects in support of regulatory science
Good words. But two important words are missing ... "with industry."
Obviously, the one-line reference to the Reagan/Udall Foundation means "with industry" and it's possible that these words which must not be spoken also reside within "partnerships and consortia." But why the strange silence about such a valuable partner? Advancing regulatory science without regular and robust collaboration from the regulated? Not likely.
Fortunately, Peggy Hamburg often speaks about working with industry on Critical Path issues. Enquiring minds want to know if any references to "industry" were blue-penciled out prior to publication -- and if so, by whom.
The white paper intelligently comments that:
There is no single discovery — no magic bullet — to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage
of 21st century technologies. And we need them now.
All said, this paper is a step in the right direction and people who work in (expletive deleted) should read it.
There’s no crying in healthcare reform.
In today’s New York Times, David Leonhardt (discussing the Presidential rhetoric used to assuage citizen uncertainty) writes, “Mr. Obama went so far as to suggest there would be no disruptions, saying that people could keep their current plan if they liked it. But that’s not quite right. It is not possible to change a system as huge, and as hugely flawed, as ours without some disruptions.”
Now that the legislation has passed, it seems as though the new talking point is, “It’s gonna get worse before it gets better.” And whether or not it’s going to get better is still very much theory (at best) and hoping (at worst).
Remember all that money that healthcare reform was going to save us? Well, since a swiftly deprogrammed Peter Orszag put that shibboleth to bed (again, in the pages of the New York Times), the debate seems to be about how insurance is going to be made more affordable. One way we’re supposed to achieve this, according to Leonhardt, is that “people will be required to buy insurance, to spread costs among the sick and the healthy.”
Sure – except that this mandate (if it doesn’t turn out to be unconstitutional) (1) doesn’t even kick in until 2014 (the same time the theoretical state exchanges come in to play) and (2) will likely penalize offenders less than even a low-cost health insurance premium. Oops.
Specific to the state exchanges that are the foundation of the theory, Leonhardt writes, “the new markets for health insurance, known as exchanges, won’t be up and running until 2014. This timetable has its problems, and the Obama administration will probably need to grant some more temporary exemptions.”
Call me when the revolution starts.
Not to say that it’s at all about politics! No penalties until 2014? If we’re in such dire straits – why not, say, right now. “It’s coming and it’s going to be great,” as a rallying cry is, plainly speaking, tanking since the reform plan is already leaking like a sieve. And it’s not going to cut it before the November elections. The truth is that it’s likely to get worse. Whether or not it gets “better” (whatever that means) depends largely on “fixes” that will necessarily be made in the next Congress.
Just what we need, healthcare sausage.
All this to say that we’d better all stop crying and start trying to think about what needs to be done beyond the talking points. After all, if it was easy, anyone could do it.
Both the left and the right hew to narratives about healthcare that comport with their worldview rather than mechanism-based analysis of treatment outcomes or evaluation of the impact of technological innovation on such interventions. Both make the assumption, badly mistaken, that quality reduces cost. Both base this mistaken assumption on the flawed Dartmouth Study that has peddled the falsehood that less care is actually better.
Peter Orszag was the peddler in chief of this notion, stating that the Dartmouth research demonstrates that at least $700 billion in health care spending is wasted each year. CMS commissar Berwick, with usual hyperbole, says that Dartmouth research shows that HALF of all health care could be eliminated and that doing do would improve outcomes.
Such statements are made in the face of research that both cite. And when they encounter a finding that conflicts with their narrative, they simply ignore it, even when citing the literature.
The most recent example is Orszag's oped in the NY Times today (Health Care’s Lost Weekend) tinyurl.com/27sfn7v
"The Dartmouth data also indicate that the N.Y.U. patients received no clear benefit for the higher cost. They saw, on average, more than 14 different doctors, compared with fewer than 10 for patients at the most efficient hospitals. But the extra visits did not seem to produce better outcomes. In fact, seeing more doctors may have caused harm, as patients ran the risk of side effects and complications from additional tests, treatments and medicines."
But Orszag cites an article in the NEJM that proves the opposite, en route to making his point.
First, weekends. It’s never good to be hospitalized, but you really don’t want to be hospitalized on a weekend. There are fewer doctors around, and people admitted on Saturdays and Sundays fare relatively poorly.
One study in 2007 found, for example, that for every 1,000 patients suffering heart attacks who were admitted to a hospital on a weekend, there were 9 to 10 more deaths than in a comparable group of patients admitted on a weekday. The weekend patients were less likely to quickly receive the invasive procedures they needed — like coronary artery bypass grafts or cardiac catheterization.
Except that the study concludes the more care leads to better outome not that more people receiving care quickly:
Overall, mortality 30 days after admission was significantly higher for patients admitted on weekends than for those admitted on weekdays...Patients admitted on weekends were less likely to undergo invasive cardiac procedures than were those admitted on weekdays....the worse outcome of weekend admissions may be due in part to a lower rate of invasive intervention.
www.nejm.org/doi/full/10.1056/NEJMoa063355#t=articleTop
This article is consistent with other studies , including those by PCORI governor Dr. Harlan Krumholz, showing that the rate of invasive intervention, once severity of illness is adjusted for, saves lives and improved outcomes
The key variable shaping re-admissions: intensity of interventional care. The shorter the stay and the fewer the procedures, the more readmissions there were.
jama.ama-assn.org/cgi/content/short/303/21/2141
When it comes to invoking quality, both the right and the left should be more circumspect about clalming it can save money. And Orszag, who perpetuated this myth, ought to lead the charge.
But one also has reasons to be a rational pessimist about innovation in large part because our society is hamstrung by free lance regulators who are able to use the government to impose the precautionary principle or their own biases on the public as a whole. We have become a nation of tattle-tales, whiners and instant experts who confuse a foot-noted declarative statement with wisdom.
Take this most recent example:
"Impressionable utes weren't the only ones watching when Cincinnati Reds owner Bob Castellini (right) passed out victory cigars and then lit up after his team clinched the NL Central title at Great American Ball Park on Tuesday.
Also watching at home on television were at least five whistle-blowers who noted that the Reds were violating Ohio's indoor-smoking ban. They called Cincinnati's health department to report the team and now the Cincinnati Enquirer reports the club is under investigation.
In case you're wondering, the answer is yes — I'm extremely sorry to report that there are people living among us who would actually do this."
Me too. Here is a list of the people and organizations among us who are now enriching themselves or making themsevles famous by using government to impose their views on the rest of us, crippling innovation in the process.
1. The anti-Avandia axis of Gardiner Harris, Steve Nissen and David Graham who have use innuendo and meta-analysis to drive Avandia into near extinction. Perhaps the FDA's decision to keep the drug on the market can be considered a victory of sort, but as someone said, another victory like this and we are done for.
2. The comparative effectivness crowd that will be telling us how much a life or product is really worth. Imagine if the same experts who now raise questions about whether a cancer drug is worth it because, on average, it adds a few months of life and costs $100k a year made the same determination about HIV drugs in 1987. In today's dollars AZT would cost $21000 a year and based on initial studes added on average about 6 months of life to patients who still suffered horribly. Today of course the cost of AZT is much lower and as Tom Philipson and co-authors found "ex-post value of hope associated with treatments for HIV patients to be as much as four times as high as standard per-capita estimates of treatment effects and as many as two and a half times as high as aggregate values across all cohorts." (Meaning across time and society.)
www.nber.org/papers/w15649.pdf
3. The board of governors of the so-called patient centered outcomes research institute which has as a member a chiropractor who lead the American Chiropractor Association and who believes that immunization should be "voluntary."
4. Those at the NIH and FDA who have hijacked The Critical Path to fund basic research that has nothing to do with creating tools that contribute to accelerating product development. You see, 'regulatory science' now means anything that could be used down the road in the development process. Basic research is much sexier and easier to get money for and avoid being attacked as providing aid and comfort to industy.
Lots of other countries provide generous R and D tax credits. They provide struggling companies with cash flow in the short term. But they are no substitute for a culture that embraces innovation. And start ups rarely become engines of commercialization and innovation.
So I am pessimistic because unlike Ridley so many people take innovation for granted and confuse. Worse, unlike Ridley, as AEI's Alex Pollock writes:
"there is a danger with intellectual brightness. It is to overemphasize and develop a bias for cleverness, quickness, facility with data, and the ability to persuade." There is a danger we all face in underestimating the pernicious influence ideas have when armed with the power of the media or government.
Pollock adds: Max Planck, the great physicist, made this provocative observation: “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.”
www.american.com/archive/2010/september/it2019s-easier-to-be-brilliant-than-right
Will we waste a generation ignoring the constants that enrich civilization in favor of shorr term policies, sound bits and cleverness with wisdom?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
