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The Alzheimer's Association has a new report on the large and growing effect of Alzheimer disease and other dementias on Americans. Here's the distillation:
- AD is the most common cause of dementia, affecting 5.3 million Americans (1.7% of the current US population). The vast majority (96%) of those affected are older than 64 years of age.
- Dementia affects women preferentially because they live longer, on average, than men. (Advancing age is the biggest risk factor for AD.)
- In 2006, AD was the 7th leading cause of death among all Americans. In those older than 64 years of age, AD was the 5th most likely cause of death.
- Next year, the first baby boomers will turn 65. In 30 years, all of the estimated 70 million baby boomers will be older than 65. The Association estimates that there will be 1 million new cases of AD by the year 2050.
- People with AD and other types of dementia need a lot of health care, including long-term and hospice care. In 2010, care costs for people with dementia will reach $172 billion. Medicare costs for people with dementia are nearly 3 times higher than those for the nondemented elderly. Medicaid costs are nearly 9 times higher. (Blogger's note: I suspect this is the result of Medicaid-funded nursing home care.)
- Older African Americans and Hispanics are about 2 and 1.5 times more likely, respectively, to have AD and other types of dementia than older whites.* Reasons for the higher risk of AD among these minorities include a greater prevalence of known risk factors for dementia, like hypertension, diabetes, and lower education and income levels. (Ethnically dependent genetic risks have not been identified.) Despite the higher risk of dementia among African Americans and Hispanics, the diagnoses is more likely to be delayed in affected minority patients. Delays in diagnosis mean missed opportunities for treatment, which is more likely to be effective in the early stages of AD.
- Last year, nearly 11 million family members or other uncompensated persons provided 12.5 billion hours of care for people with dementia. Unpaid care was assessed at $144 billion, which is more than the US government (ie, Medicare and Medicaid) spends on people with dementia. Costs of giving care are also measured in emotional and physical stress, declining caregiver health, and lost employment-related productivity.
* This is the lead of today's press release from the Alzheimer's Association.
Photograph of atrophied brain from person with AD: National Institute on Alcohol Abuse and Alcoholism.
Senator Bunning (R-KY) remains steadfast in his one-person crusade to block the passage of a bandaid bill that would extend unemployment benefits and highway funds and thwart drastic cuts to Medicare reimbursements. This morning, Bunning again blocked the Senate from taking up the measure for a vote, despite the fact that a fellow Republican, Senator Susan Collins of Maine, requested passage of a 30-day bill extension.
According to the LA Times, 41 transportation projects have been suspended, thousands of highway workers have been furloughed, and the benefits for about 100,000 unemployed Americans expired as of yesterday, because an extension was not passed. The 21% drop in Medicare reimbursement has been postponed, because the Centers for Medicare and Medicare Services (CMS) are delaying the processing of March claims.*
With respect to the Medicare cuts, James Rohack, MD, President of the American Medical Association said, "The Senate had over a year to repeal the flawed [SGR] formula that causes the annual payment cut and instead they abandoned America's seniors, making them collateral damage to their procedural games. Physicians are outraged because the cut, combined with the continued instability in the system, will force them to make difficult practice changes including limiting the number of Medicare patients they can treat."
Selected comments from practicing physicians at the AMA web site indicate that the drop in Medicare reimbursement will cause many physicians to dramatically reduce or eliminate Medicare patients from their practices. Practices that cater chiefly to elderly patients are likely to fold altogether.
According to USA Today, Senate Democrats are "planning an end-run around the unemployment and health benefits bill" by creating legislation that will extend benefits to the end of 2010. The stopgap measure, which would be retroactive, is due to come up for a vote next week.
* According to the American Academy of Neurology, the Centers for Medicare and Medicaid Services (CMS) extended its grace period for processing March claims from the 10th to the 17th. The CMS extension is made in anticipation of any retroactive legislation that will stave off Medicare cuts.
Update: In late developments, Bunning has relented and will allow a Senate vote tonight on the extension bill, reports USA Today.
03/03/10 update: Last night, President Obama signed a bill that enables an extension of the current Medicare reimbursement rates to April 1st, reports Medscape. A small poll at the website indicates that 65% of 40 physician respondents would stop or cut back on seeing Medicare patients, if the 21% cut in Medicare reimbursement had gone into effect. Medscape also reports that Senate Democrats are working on a longer-term fix, the American Workers, State, and Business Relief Act, which would delay the SGR formula-defined cuts in Medicare reimbursement to October 1st. Permanent fixes, specifically a House measure that repeals the SGR formula, are also in the works—although any such bill would add considerably to the federal deficit.
Doctors across the United States are throwing hate bombs in the direction of Kentucky, the home of Senator Jim Bunning. The ire is in response to the Senator's repeated objections yesterday and today to delay the upcoming 21% Medicare reimbursement cuts. The cuts are due to occur Monday, March 1, if legislation to postpone the measure is not passed by Congress.
Bunning delayed passage of last-minute legislation that would extend unemployment benefits, highway funding, and current Medicare reimbursement rates that were due to expire at the end of this month. Bunning's justification for his lone obstinacy is that the extensions would increase the government's budget deficit, according to several news sources. The political fallout for the Senator is minimized, because he does not plan to seek re-election.
For continuing coverage of this developing story, hit the NYT's The Caucus Blog.
Update: To ease the financial hardship for physicians who are dependent on Medicare reimbursement and to buy time for the passage of retroactive legislation, the Centers for Medicare and Medicaid Services (CMS) will not process March claims for the first 10 days of the month, reports Medscape. CMS has instigated delays in claims processing before, when Medicare cuts loomed: once in July 2008, and once in December 2009. The cuts in Medicare reimbursement are determined by CMS's sustainable growth rate (SGR) formula.
Photo of Senator Bunning from http://bunning.senate.gov/.
A London pediatrician's diary shows that Haiti desperately needs, more than surgeons, supplies and coordination.
Writing for the Evening Standard, Dr. Nathaniel Segaren of the Caris Foundation, logs his week of guilt, frustration, appall, effort, and anguish among the mayhem. He concludes, "I realise we can be of most help with our knowledge of the city's geography and our ability to speak a combination of French, English and Creole." The ultimate intent becomes to select, with exceptional agony, those patients for transfer to a floating US Navy hospital—which is already beyond capacity.
"There are lots of egos here and mini power struggles," Segaren observes, "People are desperate to claim credit and get maximum media coverage."
From the UN via Flickr: Photo of 18-year-old Haitian girl with head trauma being transported to USS Comfort, a floating hospital.
The short answer: it really isn't a mandate.
Yale law professor Jack Balkin explains further in his "Perspective" piece in this week's NEJM.
Balkin's overarching argument is that the requirement to purchase health insurance, described in both the House and Senate forms of the healthcare reform bill, is really a tax* on those persons** who fail to purchase health insurance. And, according to the Constitution, Congress has the power to legislate taxes that serve the general welfare. End of story.
Balkin predicts that the Supreme Court won't even touch the health-insurance mandate/tax issue, unless a federal court of appeals knocks it down. And in that case, the high court will uphold it.
* In the House version of the bill, the income of the uninsured is taxed; in the Senate version, an uninsured individual is taxed on an event basis--meaning, he is taxed each month that he doesn't purchase health insurance.
** Meaning individuals who don't already have employer-provided health insurance. The "mandate" also does not apply to dependents, Medicare or Medicaid recipients, military families, overseas ex-pats, or religious objectors.
Off-topic addendum: In the Age of Transparency, the NEJM has evidently found a way to avoid the multiple columns of small type that are sometimes necessary to print all of the disclosures of its published authors. Provide an online link instead to the author's filled-out disclosure form.
Among the major differences between the House and Senate healthcare reform bills is this issue: Who will oversee the newly created competitive insurance "exchange"—a sort of Expedia.com equivalent for the 30 million people without job-provided health insurance? The House bill proposes national regulation of the exchange; the Senate wants state-level oversight. Both Congressional bodies have their points, according to today's WSJ.
House Democrats want federal regulation to promote consistency and thwart insurers who would try to create and exploit loopholes at the state level. House legislators believe they're owed this concession in exchange for eliminating a new government public insurance plan in the final bill.
The Senate and the insurance industry, on the other hand, want states to regulate the exchange—arguing that state administrators have a better understanding of the local markets and their consumers. Proponents of state regulation also cite the substandard federal regulation and abuse of Medicare Advantage plans.
Another bone of contention for the insurance industry is the Senate's proposed tax on high-premium group-health plans—a tax that is intended, in part, to finance healthcare reform. Insurers want the tax reduced and phased in. Otherwise the industry will have to pay up to $224 billion during the next decade, estimates a top insurance lobbyist.
For the record, President Obama wants the tax on high-premium group-health plans in the final bill.
No. 1: Pandemic H1N1
You were expecting something else?
Coming out of left field (ie, Mexico)* in April, the novel 2009 H1N1 ("swine flu") virus caused an official global pandemic in June, according to the World Health Organization. Cases mounted rapidly, but fear of disease was mitigated by its relatively low mortality rate.** Drawing on their experience from the swine-flu epidemic of 1976, leading US neurologists first believed that a government-led vaccination campaign would be unlikely because of 1) low mortality and 2) the possibility of vaccine-associated Guillain-Barre syndrome (GBS). Boy, were they wrong.
In August, the CDC released its recommendations for the administration of developing H1N1 vaccines to 5 groups. The surprise: Instead of the historically targeted elderly, the CDC prioritized vaccination for children, young adults, and pregnant women because of their emerging risks of disease-related complications and death. Consequently vaccination was recommended for an estimated 159 million Americans as soon as vaccines became available, sometime in mid-October.
In May, the DHHS had contracted with 5 companies—CSL Biotherapies, GSK, MedImmune, Novartis, and sanofi-pasteur—to produce either injectable or nasally administered vaccines for pandemic H1N1 to the tune of $932 million. Government orders for another $883,977,920 and $438,143,025 were placed in July and September, respectively. The total amounted to about 9 bucks per vaccine, which was being produced by the traditional method of viral incubation in fertilized chicken eggs.
This tried-and-true method ultimately led to a delay in vaccine production for 2 primary reasons: the fastidious nature of the 2009 H1N1 virus (when compared with seasonal influenza viruses) and limited chicken eggs. Turns out the pandemic virus required 2 eggs to create a single vaccine dose, instead of the usual one. By October, the federally contracted companies had only cranked out about 10% of the promised 120 million vaccine doses for US residents. Time was a-wastin'.
In October, the CDC investigators estimated that about 3 million citizens had already experienced symptomatic pandemic flu between April and July, on the basis of a probabilistic model. Confirming previous assessments, the incidence of disease and disease-related hospitalizations were considerably higher in children and young adults. Pandemic flu, overall, had necessitated about 14,000 hospitalizations and had caused about 800 deaths in the United States.
The following month, the CDC estimated that up to 34 million Americans had been infected between April and mid-October. Respective hospitalizations and deaths now ranged from 63,000 to 153,000 and from 2500 to 6000. Another age breakdown revealed that disproportionate numbers of younger adults (and to a lesser extent, children) remained susceptible to pandemic flu generally and severe disease specifically. About 45% of Americans who had died from pandemic flu had been healthy.
And then disease began to wane. Earlier this month, only 25 states reported widespread activity. At the same time, data showed that the pandemic flu vaccines (the supplies of which were up) remained effective and were comparably safe. Specifically the risk of GBS appeared no higher than the typical background rate.
The latest recommendations: More than 30 "major health care provider organizations," including the American Medical Association, the American Academy of Pediatrics, and the American Red Cross, are encouraging all US residents to receive a pandemic flu vaccine in anticipation of another wave of infection. An "open letter" to the American people states,
The H1N1 flu vaccine is safe, effective, and the best way to protect yourself and your family from the H1N1 flu. Over 110 million doses...are now available, with more coming every day. Now is the time to protect yourself and those around you by getting vaccinated against the H1N1 flu.
Links to selected Pathophilia posts on pandemic flu (and a few on seasonal flu) are provided here in chronological order.
* Instead of the historically expected East Asia.
** Estimated in the United States at 0.007%-0.032%.
Depiction of H1N1 virus from Wikipedia.
No. 2: US House and Senate Pass Their Respective Healthcare Reform Bills
They said it couldn't be done, and they might still be right; but with a strong administrative push to reform America's sickly healthcare system, both the House and the Senate passed their respective bills this year. To the tune of more than $1 trillion in anticipated costs, the House measure narrowly passed on November 7. The price tag for the Senate bill, which ultimately prevailed on Christmas Eve, is a relative bargain at $871 million. The major difference between the two bills: the creation of a new government (ie, public) insurance plan, which the House bill stipulates.
Not much posting here at the Pathophilia blog about healthcare reform, largely because the topic seemed like such a complicated mess. The New York Times is the recommended go-to source, however. Among the paper's many useful features on the subject is a comparison of the proposed bills, an abbreviated version of which is tabulated here.
|
Bill Feature |
House |
Senate |
|
Mandates minimum-level health insurance, with penalties for uninsured |
Yes |
Yes |
|
Requires most employers to contribute to coverage for employees, with penalties for not complying |
Yes |
Sort of |
|
Creates insurance "exchange," or competitive insurance marketplace, for individuals and employers |
Yes [a] |
Yes [b] |
|
Creates new government (ie, public) insurance plan |
Yes |
No |
|
Subsidizes (ie, provides tax credits to) low- or middle-income persons to buy insurance |
Yes |
Yes |
|
Subsidizes small business to provide employee insurance |
Yes |
Yes |
|
Expands Medicaid |
Yes |
Yes |
|
Defines minimum allowable insurance package |
Yes |
Yes |
|
Prohibits denial of coverage owing to preexisting conditions |
Yes |
Yes |
|
Requires plans to offer coverage for dependents up to at least 25 years of age |
Yes |
Yes |
|
Creates voluntary federal disability-insurance program |
Yes |
Yes |
|
Requires coverage for abortion |
No |
No |
|
Allows illegal immigrants to buy exchange plans |
Yes [c] |
No |
|
Eliminates Children's Health Insurance Program (CHIP) |
Yes [d] |
No [e] |
a. At national level.
b. At state or regional level.
c. But not eligible for federal subsidies.
d. Coverage now through Medicaid or national insurance exchange.
e. Would extend CHIP.
The House's reform would be supported by new taxes on medical devices and individuals with very high incomes (eg, >$500,000). The Senate would levy a hefty tax on high-premium group-health plans and charge annual fees to drug, device, and insurance companies. Both bills would attempt to "squeeze" hundreds of billions of dollars out of Medicare by restricting its growth.
To my knowledge, neither bill proposes cost savings through the use of information technology (IT)—which is probably wise. Harvard researchers recently concluded that IT doesn't reduce hospital costs.
In the midst of the 2009 pandemic influenza epidemic, BMJ editor Fiona Godlee takes Roche to task for not supplying the necessary data to confirm or refute the benefits of oseltamivir (Tamiflu) in otherwise healthy people with influenza. In one of 2 BMJ editorials, Godlee chides Roche for not supplying unconditional access to raw data from a pooled analysis of 10 company-sponsored trials (Kaiser et al; PubMed link here) to Cochrane reviewers Jefferson et al. Consequently the reviewers were "obliged to disregard" the bulk of these data (8 of the 10 trials) and were unable to verify that oseltamivir prevents lower-respiratory-tract complications (eg, pneumonia) due to influenza.
In their previous 2006 Cochrane review, Jefferson et al had concluded that oseltamivir 150 mg daily prevents such complications on the basis of the Kaiser article. However, the authors were criticized through a public feedback mechanism for using the 10-trial analysis without having access to the raw data. Prompted by this criticism, Jefferson et al then conducted another review, published this week in the BMJ, in which they affirmed their critic's perspective:
Data on the effectiveness of oseltamivir against complications of influenza principally came from one study...This was a meta-analysis of 10 trials containing a mixture of published and unpublished data, two of which are reported in this update and the remainder inaccessible to proper scrutiny, so that we are now obliged to disregard them. The remaining data showed no benefit for oseltamivir against complications.
In her editorial, Godlee asks, "Where does this leave oseltamivir, on which governments around the world have spent billions of pounds?" She, moreover, emphasizes that the Cochrane review data apply only to healthy adults with influenza, but they "say nothing about [oseltamivir's] use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions." Even the drug's ability to reduce influenza-related symptoms (which Jefferson et al reconfirmed) are doubted, because there are no head-to-head studies with oseltamivir and NSAIDs, for instance.
In another BMJ editorial (with Cochrane director Mike Clarke), Godlee concludes that the latest Cochrane review and a "linked investigation undertaken jointly by the BMJ and Channel 4 News cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted." In their investigation, Cochrane reviewers became concerned about the actual involvement of listed authors on the Kaiser analysis, the possibility of ghostwriting, the high rates of influenza in the trials, and the low rates of serious adverse events.
Initial responses from Roche employees, who first declined to provide the data and then offered selected files, were less than satisfactory to the reviewers. The latest response from the company: it is "committed to making the 'full study reports' available on a password protected site soon."
On the basis of this experience, Godlee and Clarke conclude that the current system for reporting drug research "isn't working" and offer a number of potential remedies—including government-mandated access to raw data that are used to license and market a drug (eg, something in the spirit of the FDA Amendments Act of 2007).
News sources are all over this story (eg, Bloomberg), and the BMJ offers full-text access to the following relevant articles, including a response from a Roche employee—who chastises Jefferson et al for enlisting the investigative help of a TV news station.**
- Godlee F. We want raw data, now.
- Godlee F, Clarke M. Why don't we have all the evidence on oseltamivir?
- Smith J, on behalf of Roche. Roche replies to the authors of the Cochrane Review on oseltamivir.
- Cohen D. Complications: tracking down the data on oseltamivir.
- Doshi P. Neuraminidase inhibitors--the story behind the Cochrane review.
- Freemantle N, Calvert M. What can we learn from observational studies of oseltamivir to treat influenza in healthy adults?
- Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis.
- Web extra (including the criticism that got the ball rolling).
* And I mean that in the nicest possible way.
** Roche's Smith writes, "It is unclear to us why Dr Jefferson would adopt this approach, particularly given that he was a paid ad hoc consultant to Roche working on flu and oseltamivir between 1997 and 1999. During that period he worked closely with Roche experts, many of whom are still in the company, and he would therefore not have had difficulty in contacting them directly to discuss his requirements."
Photo from Vermin Inc at Flickr.
The subject of hot partisan debate, the current version of the Senate healthcare reform bill, HR 3590 (the "Patient Protection and Affordable Care Act"), provides a much-needed and long-overdue financial incentive for primary care physicians to continue to offer primary care. In its present version, the proposed bill states,
In the case of primary care services furnished on or after January 1,
20012011, and before January 1, 2016, by a primary care practitioner, in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid (on a monthly or quarterly basis) an amount equal to 10 percent of the payment amount for the service under this part.
The bill defines a primary care practitioner as 1) a physician who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine,* and 2) a healthcare professional whose billed primary care services make up at least 60% of practice. (Primary care services, defined by CPT codes, are essentially all non-procedure-related services—ie, evaluation and management services.)
The problem with the current wording of the bill—as far as neurologists and their flagship organization, the American Academy of Neurology (AAN), are concerned—is that the primary care incentive omits neurologists: physicians whose practices, like those of traditionally defined primary care physicians, consist of substantial face-to-face time and care.
According to AAN officers in today's member teleconference, the bill's oversight is partly due to congressional ignorance: MedPAC, the government agency that makes recommendations to Congress about Medicare policy, mistakenly assumed neurology to be an internal medicine specialty, like rheumatology or endocrinology. (In the eyes of the government, a physician's specialty is determined by a designated specialty code. Unlike neurologists, rheumatologists or endocrinologists can designate themselves as internal medicine practitioners on the basis of their postgraduate clinical training and/or board certification.) The other gross misjudgment is that neurology is synonymous with the wildly different practice of neurosurgery.
The continued omission of neurology from the bill's definition of primary care, the AAN reasonably argues, would further erode a valuable medical specialty—which currently matches only 52% of available residency slots.** And yet, despite the shortage of neurologists, their services have been shown (for example, in the case of stroke patients) to reduce hospital stays and costs and to improve clinical outcomes.
The AAN reports that Senator Amy Kobuchar (D-MN) has agreed to introduce an amendment that would add "neurology" to the pertinent section of HR 3590. The proposal is currently in need of a Senate cosponsor. Several patient groups, representing individuals with Parkinson disease, epilepsy, traumatic brain injury, ALS, or headache, advocate the inclusion of neurology in the bill's incentive section for primary care physicians.
To support the inclusion of neurology as a primary care practice in healthcare reform legislation, the AAN recommends that members visit BrainPAC and write their federal legislators.
* Nurse practitioners, clinical nurse specialists, and physician assistants are also included. In the House bill, obstetricians/gynecologists are included.
** Neurology's match percentage is comparable to that of family medicine and internal medicine, according to AAN President-Elect Bruce Sigsbee, MD.
