humani nil a me alienum puto

random rants about news, the law, healthcare law, economics and anything I find amusing

A Hodgepodge Bends the Curve?

In the health care reform season, this seems to be another necessary read.  As I have posted before, I think that Dr. Gawande is channeling many of the administration’s views — or at least those views of Mr. Orzag (see December 7, 2009 post).  I don’t mean, at all, that Dr. Gawande is taking a lead from the administration or that he is not the intellectual owner of many of the ideas in this article — particularly the analogy in this article with the U.S.D.A.   I mean that it seems that he is simpatico with at least some of the administration’s views on health care reform and deserves thoughtful review for that reason.

The article can be summed up with this paragraph:

There are, in human affairs, two kinds of problems: those which are amenable to a technical solution and those which are not. Universal health-care coverage belongs to the first category: you can pick one of several possible solutions, pass a bill, and (allowing for some tinkering around the edges) it will happen. Problems of the second kind [e.g., bending the health care cost curve], by contrast, are never solved, exactly; they are managed. Reforming the agricultural system so that it serves the country’s needs has been a process, involving millions of farmers pursuing their individual interests. This could not happen by fiat. There was no one-time fix. The same goes for reforming the health-care system so that it serves the country’s needs. No nation has escaped the cost problem: the expenditure curves have outpaced inflation around the world. Nobody has found a master switch that you can flip to make the problem go away. If we want to start solving it, we first need to recognize that there is no technical solution.

via How the Senate bill would contain the cost of health care : The New Yorker.

He’s saying that to bend the curve, significant but micro/local involvement and almost ‘federal’ (in the political sense – giving great authority to subunits to find better solutions) problem solving is necessary.  There is no elegant single panacea by legislative fiat to address the problem of escalating health care costs .   Ergo, the Senate bill’s reliance on a ‘hodgepodge’ of pilot programs coupled with an agency, the new Medicare advisory commission, that can expand pilots that work, may be an organic and evolving mechanism to ‘manage’ the challenge.  This, at least, is the thesis.

Dr. Gawande believes that the U.S.A.D.’s experience is a good analogy to the current health care industry challenges.  I’m not convinced of the analogy made here to the U.S.A.D.’s initiatives of early last century (and on to today).  It does seem to have some merits, while simplifying the unique economic distortions in the health care market.  Individual farmers, once they experienced the production benefits that modern techniques (and access to capital machinery) could yield, had every economic incentive to pursue these.   First, because they could make much more crop; second, that if they did not do what their neighbors did, they’d soon be unable to compete as market prices declined.  He does make the point that continuing government ‘help’ – particularly to individual farmers with limited resources, continues today.

To make my own metaphor, the farmers’ trucks were stuck in the mud on a downhill slope with the government giving them some assistance to get them out.  Once out of the mud’s inertia, the market took over.  But query what type of mud the ambulance of health care is stuck in and what’s the grade of the health care market’s hill?

But in any event, given the number of pilot programs and experiments in health care payment and quality measures in both the Senate (see recent amendments proposed by Warner – D Virginia – BNA access only) and the House’s bills, we’re in for an interesting period of experimentation in health care payment systems.  As always, those that can quickly react to this change will be in a far better position than their competitor organizations.  It will be particularly important, if Dr. Gawande’s vision is correct, for organizations not participating in these pilots to closely monitor them, identifying what seems to be working and plan how to adapt to them if they are put more widely into use.

In any event, a necessary read.

Filed under: Health Law, Reform, ,

Another View – Get Rid of Comprehensive Healthcare Insurance?

Thanks to Paul Levy’s Running a Hospital blog for putting me onto this article.  I started reading this too late but could not pull myself away from it.

If you are pondering health care reform this season, “How American Health Care Killed My Father” by David Goldhill should be something you read.  He’s an outsider to health care finance and delivery and a consumer that has had the healthcare system profoundly (and negatively) affect his family.

With this personal interest, he’s become quite focused on the question: how can a technically advanced, high cost, reputable, New York area hospital with caring, highly educated and highly skilled physicians and nurses allow his father to die from a facility acquired infection avoidable (probably) by adequate hand-washing protocols?  The experience has led him to an “obsession with [the] health-care system” and to start asking how could it possibly be structured the way that it is.   With this background, he asks whether today’s proposed reforms actually fix what he understands to be wrong with the American health care system?  His conclusion is no:

The most important single step we can take toward truly reforming our system is to move away from comprehensive health insurance as the single model for financing care. And a guiding principle of any reform should be to put the consumer, not the insurer or the government, at the center of the system. I believe if the government took on the goal of better supporting consumers—by bringing greater transparency and competition to the health-care industry, and by directly subsidizing those who can’t afford care—we’d find that consumers could buy much more of their care directly than we might initially think, and that over time we’d see better care and better service, at lower cost, as a result.

A more consumer-centered health-care system would not rely on a single form of financing for health-care purchases; it would make use of different sorts of financing for different elements of care—with routine care funded largely out of our incomes; major, predictable expenses (including much end-of-life care) funded by savings and credit; and massive, unpredictable expenses funded by insurance.

I take issue with some of what he writes, particularly about hospitals.  Nonetheless, it is worth a read and some serious thought, whether you agree or not with all of his statements, conclusions and his solution.

via How American Health Care Killed My Father – The Atlantic (September 2009).

Filed under: Health Law, Reform, , , ,

H1N1, CDC, CMS and EMTALA

In a follow-up to previous posts (here, here) on H1N1, I’m catching up on reading from this week and I must have missed the White House’s report on possible effects of a resurgence of the swine flu pandemic this fall and winter.   I read through the report and it is eye opening, although not as dire as some possible scenarios presented by at least some for a pandemic avian flu.  According to the White House advisory panel report a possible scenario would:

•produce infection of 30–50% of the U.S. population this fall and winter, with symptoms in approximately 20–40% of the population (60–120 million people), more than half of whom would seek medical attention.
•lead to as many as 1.8 million U.S. hospital admissions during the epidemic, with up to 300,000 patients requiring care in intensive care units (ICUs). Importantly, these very ill patients could occupy 50–100 percent of all ICU beds in affected regions of the country at the peak of the epidemic and could place enormous stress on ICU units, which normally operate close to capacity.
•cause between 30,000 and 90,000 deaths in the United States, concentrated among children
and young adults. In contrast, the 30,000–40,000 annual deaths typically associated with seasonal flu in the United States occur mainly among people over 65. As a result, 2009-H1N1 would lead to many more years of life lost.
•pose especially high risks for individuals with certain pre-existing conditions, including pregnant women and patients with neurological disorders or respiratory impairment, diabetes, or severe obesity and possibly for certain populations, such as Native Americans.

The NY Times later reported that the CDC had indicated that this was not a “likely scenario,” which may be reassuring.

Also of note, The Centers for Medicare & Medicaid Services  issued a memo and fact sheet clarifying permissible options under the Emergency Medical Treatment and Labor Act for hospitals handling a surge in patients with swine flu.  The fact sheet discusses options for hospitals experiencing surges with and without a declared ‘waiver’ of EMTALA (requiring presidential emergency declaration and certain other actions), including out of department medical screening exams and off-campus flu screening centers.

PCAST_H1N1_Report.pdf (application/pdf Object).

Filed under: Health Law, Public Health, , , ,

Healthcare Economic – Supply/Demand Side Goals to Reform

Over the years Uwe E. Reinhardt has written, lectured and testified extensively on health care economics, alternative health care financing and delivery systems (e.g., here and here) and health care financing and delivery reform in the United States.  He’s one of those guys I recall studying back in undergraduate health care economics classes (who can forget a name like Uwe).

In a recent NYT Economix blog post he provides succinct economics supply side/demand side breakdown of what the general economic goals are for health care financing and delivery reform as currently evisioned.  I thought was a useful way of looking at the (rational) parts of the current debate.   I emphatically take no position on health care reform policy initiatives, but in light of so much of the rather less than civil polemics I see around the policy debate, this seems a return to basic analytics of what might be accomplished through reform.

1. Financial barriers should not stand between Americans and preventive or acute health care that they sincerely believe will address concerns over a troubling medical condition, in a timely manner, before that condition grows into a critically serious illness.

2. Having received needed health care, no American family should be so financially devastated by medical bills that it cannot meet routine daily living expenses — for example, make utility or mortgage payments on time or finance the education of the family’s children.

3. The future growth in national health spending should be constrained to fall significantly below currently projected spending growth, which has the United States devoting about 40 percent of its G.D.P. to health care by midcentury.All other goals are subordinate to these three overarching goals, as are the means to reach them.

He breaks it down into into one slide — which I think, again, fairly succinctly states the targeted supply/demand side areas:

I found it natural to categorize these components into those aimed mainly at reforming the demand side of the health sector, those aimed mainly at the supply side, and those cutting across both sides — e.g., payment reform and overall cost control.health care delivery

He then discusses the time frame for reform.   He feels with good reason that the supply side fix (top left box), while incredibly challenging, would be achievable through current legislation.   He indicates, however, that it would not be particularly successful unless certain core requirements are met to address the adverse selection/moral hazard problems inherent in the fix.

He notes, however, that the right box and the cross-cutting payment reform (bottom boxes) can only be accomplished over a much extended period due to their complexity, lack of current infrastructure (e.g., systemic and cross-functional EHR systems, solid quality measurement systems, systems whereby health care providers can assume and manage financial risk for populations) and a public policy and business driven process of how to actually move from FFS systems to some form of bundled payment or capitation.

If 1) either private or public health insurers must accept all comers and may not base premiums on the applicant’s health status, then 2)  individuals must be mandated to purchase at least a basic package of health insurance, lest they freeload on the system. Such a mandate, in turn, requires that 3) families be publicly subsidized to make the cost of that basic package affordable to them. A sound reform of the health insurance market cannot have just two of these features. It must have all three.

****

Designing and implementing the rest of the reform agenda in the chart — reforming the supply side, payment reform and cost control — is a much longer-run effort that may take an entire decade or more. It is more challenging than was landing a man on the moon, as no moneyed lunar interest groups sought to prevent man’s visit there.

The delema should be obvious.  Given Dr. Reinhardt’s core requirements for supply side reform, the ability to subsidize #1 (preventative intervention) and #2 (insurance against catostrophic financial loss due to illness) universally is going to be extraordinarily costly to public fisc.  Without management of #3 (which isn’t going to come without significant challenge) the money must come from somewhere.  And, of course, if #3 is not achievable for some unspecified extended period, gap financing is necessary.   Richard Posner recently has a post on just this point.

Filed under: Health Law, Personal Posts, Reform, , , ,

Rights to the Bits and Bytes in Your EHR

Back in 2001, right before the HIPAA privacy rules took effect, I wrote a law school student note entitled “The Emergence of the Health Care Information Trust.”  Pretty heady, and perhaps a bit Pollyanna-ish, stuff.  In the note I argued that to pull the hidden value of disparate health care information out of the islands of digital data that had been forming throughout the health care system, some form of clearing house for patients, with strong fiduciary obligation to individual patients participants, needed to emerge.  In fact, because of HIPAA’s soon to be finalized privacy regulations, without patients expressly vesting rights in something like a health care data aggregator,  it would be very difficult (if not impossible) to use the information commercially for purposes other than directly for healthcare treatment, payment, operations and certain research.  Further, the value in that data would not be able to accrue to the individual any other way.  My concept was to allow use of patient data, with defined limitations set by the patient, with micropayments to patients for such patient approved use by anyone seeking to access the aggregated data.

Anyway, the eight years since I wrote the article, I am not sure where the health care data market is going.  But there are some services that seem to be starting to emerge as potential aggregators.  Most notably, both Microsoft and Google have been taking initiatives in the area.  Of course, Microsoft and Google are not what I had projected; but it probably makes more sense in hindsight that the two biggest IT juggernaughts would be making headways into this this very young market with unknown potential.  If anything, the ability to pull good, useful and linkable health care information (except maybe healthcare claims data) is a monumental problem, and true electronic medical records are, at best, still in their infancy.  So, also, the immediate possibilities of wide-scale transfers to such aggregators.

One of the obvious limitations, even if and when health record data is transferable without impossibly difficult transactional barriers and costs, is the fact that the privacy regulations are really set up to address patient rights in principally paper records.   So, even if you wished to transmit electronic data to an aggregator service (be it my concept of a Healthcare Information Trust or, for that matter, Google or Microsoft), there are no express provisions addressing this.

So I found it interesting when I read about “A Declaration of Health Data Rights.”  In it, the organization specifically makes mention to access to records in “computable form.”  Also, in reading about the initiative in the NYT’s Bits blog, I took particular note that both Microsoft and Google have a role in it.  Ah, this makes some sense now.

For what its worth, the group desires:

A Declaration of Health Data Rights

In an era when technology allows personal health information to be more easily stored, updated, accessed and exchanged, the following rights should be self-evident and inalienable. We the people:

1. Have the right to our own health data

2. Have the right to know the source of each health data element

3. Have the right to take possession of a complete copy of our individual health data, without delay, at minimal or no cost; if data exist in computable form, they must be made available in that form

4. Have the right to share our health data with others as we see fit

These principles express basic human rights as well as essential elements of health care that is participatory, appropriate and in the interests of each patient. No law or policy should abridge these rights.

via HealthDataRights.org.

Filed under: Health Law, HIPAA, , , ,

Reform Moves Stir Talk of Bundled Payments | BNET Healthcare Blog | BNET

A BNet article, Reform Moves Stir Talk of Bundled Payments, discusses healthcare reformers’ conceptualizing bundling payments to align physician and health system/hospital outcome interests.  The article has a number of cites to other reports, discussions and administration statements.  It also points out what I find facinating about the trend — what did not occur in the 1990s may be coming through healthcare payment reform today.   But are today’s integrated delivery systems (and the regulatory environment) prepared for risk in any format other than PPS payments?

All of this reminds some observers of the rapid formation of integrated delivery systems during the ‘90s, when many hospitals and physicians were circling the wagons to fend off the expected onslaught of capitated managed care plans. That never materialized in most places, but many systems retained all or some of their employed primary-care physicians. Now, partly in expectation of healthcare reform, they’re also stepping up their hiring of specialists.

“The handwriting is on the wall,” Bill Jessee, MD, president and CEO of the Medical Group Management Association, tells BNET. “The push is going to be towards more integration of physicians, hospitals, home health, and other services. And Medicare or a private insurer may put the provider at risk, instead of the insurer being at risk. It’s not explicit, but it’s implicit in a lot of the reform discussions that that’s the direction they’d like to move. The bundled payment demonstrations are a manifestation of that.”

via Reform Moves Stir Talk of Bundled Payments | BNET Healthcare Blog | BNET.

Filed under: Comparative Effectiveness Rearch, Health Law, Payment, Reform, , , ,

Who are the Uninsured?

Back in 2005, I co-authored an article with Richard Stuhan, a partner at Jones Day.  The article was primarily about the concerted and misguided  efforts to sue non-profit hospitals for their alleged failure to provide charity care.  The plaintiffs contended that such provision of charity care was a legal obligations of 501(c)(3) tax exempt entities.   These suits, while striking the public policy cord concerning the plight of the uninsured and the inflation of health care costs and charges, were based upon ill conceived legal theories and, accordingly,  failed miserably.  But they probably were a precursor of congressional interest in charity care provided by non-profit hospitals and health systems — which is currently playing out and has resulted in some significant changes, most notably the new Form 990s.

One of the items we briefly discussed in that article, an issue that should be a major large part of the health care reform debate, is the scope of the health care insurance (or, more particularly, uninsured) problem in the United States.  Who accounts for the uninsured figures and why are they uninsured is critical to forming the debate about solutions.  The debate, I would think, is fundamentally different if a substantial portion of the uninsured could afford insurance or could access other forms of insurance (SCHIP, Medicaid, etc.), but decide for personal reasons not to obtain insurance or face administrative, educational or transactional barriers to signing-up for federal or state-sponsored insurance programs for which they would otherwise be eligible.   Circa 2003, the uninsured level was approximately 45 million, but a very significant portion of this populations was either eligible for federal or state programs or were from households that were significantly above the federal poverty level and could, technically, afford insurance.

Periodically, this issue has popped up with one study or another discussing the scope of the uninsured problem — addressing who are they, why are they not insured.   Of course, with this new round of health care reform, the issue of the uninsured should be front in center in the debate.  Recently, a report was issued entitled WHO ARE THE UNINSURED? An Analysis of the Characteristics of Americans Without Health Insurance by the Employment Policies Institute.   This seems to be a fairly politicized organization that has written studies before that have been scorned by some.   So, with that disclaimer and taking the study with a grain of salt, its conclusions are still notable. Assuming its numbers are correct, approximately 43% of the 2006 18-64 year-old uninsured are in households at greater than 2.5x the federal poverty limit.  This is not inconsistent with previous studies I had seen and I would think could be fact checked.

By no means does this take away from the significant and troubling 47% who are involuntarily uninsured.   But the number of individuals and households that have the means to, but choose not to, purchase health care insurance is important to the current debate.  What impact does this very significant portion of the uninsured have for risks of adverse selection, individual/employer mandatory coverage requirements, the level FPL subsidies and other components of healthcare reform bills being proposed.

Filed under: Health Law, Reform, , , , ,

World Bank and H1N1 Economic Forecast

In a follow-up to one of my prior posts (Birds or Pigs?; Pigs Have It), I spotted (thanks to the WSJ Health Blog and Bloomberg) that the The World Bank issued a recent report on the global recovery, entitled Global Development Finance: Charting a Global Recovery.  In it it discusses the potential impact of H1N1 on economic recovery, estimating that by next season the impact of H1N1 is likely to be at least as severe as the Hong Kong Flue of 1968-69.  It also cites other studies to give a range of potential impact on world-wide GNP between 0.7% and 4.8%.   The impact on Mexico, where H1N1 has had a severe effect on tourism and has shut down large sectors of its economy at the start of (or at least the realization of) the outbreak, has been severe.  Estimates are a second quarter 2009 decrease in that country’s output by appoximately 2.2%.

Simulations of the potential economic and human costs of a global pandemic undertaken for the 2006 Global Development Finance report in the context of avian influenza (Burns, van der Mensbrugghe, and Timmer 2006, 2008) suggest that the costs of a global influenza pandemic could range from 0.7 to 4.8 percent of global GDP depending on the severity of the outbreak. The lower estimate is based on the Hong Kong flu of 1968–69, while the upper bound was benchmarked on the 1918–19 Spanish flu. In the case of a serious flu, 70 percent of the overall economic cost would come from absenteeism and efforts to avoid infection. Generally speaking, developing countries would be hardest hit, because higher population densities, relatively weak health care systems, and poverty accentuate the economic impacts in some countries.

Filed under: Health Law, Personal Posts, Public Health, , , ,

The Human Analog to a Pet or a Public Resource?

Uwe Reinhardt has a piece on the Economix blog arguing for universal coverage and public financing of children’s health insurance through age 22.  Dr. Reinhardt is a professor of economics at Princeton University and a leading health policy expert.

What’s most notable about his post is his provocative start.  He asks the question:  do we in the United States view children as the “human analogs of pets … or…, as most European and Asians, as precious national treasures.”  Kind of  a disturbing question, when you think about it.  What’s he getting at?

He believes that answering this question “informs the nation’s health policy.”

If …the human analog of their parents’ pets, then … children’s health care is primarily the parents’ financial responsibility [and]…it is just and proper that, of two households with identical incomes, the one with children will have substantially less discretionary income …than does the childless household.  [I]f …national treasures — and the nation’s economic future — then …health care of children [is] the financial responsibility of society as a whole, just as is the financing of public elementary and secondary education.

Aside from remarking about S-chip and the 9 million children that are estimated to be uninsured, he also observes that Americans “seem to impute different social values to the health care of children, depending on their socioeconomic status, even if they have insurance.”  In other words, there can be a hundred dollar or more swing in basic primary care reimbursement depending whether a child is insured through private payors or public public programs.  And this price signal has real effects – many physicians, including many in Reinhardt’s New Jersey, will simply refuse to see Medicaid patients.

He then goes on to argue that a system similar to our public school system — but with vouchers for parents who would opt out of the public system — should be established for all American children under 22:

The purchasing function under this public program, that is organizing and managing care, could be delegated to private for-profit or nonprofit insurers, as in Medicaid Managed Care. Private insurers would then compete over the quality of their disease-management programs, not through judicious risk selection…[T]he fees paid providers under the public program would be set equal to the average of fees paid by the largest two or three private insurers in the state, lest the professional work of physicians caring for poor children continue to be relatively undervalued.

I think this is interesting reading in light of the McKinsey Study that I posted on recently.  If suboptimal health care is a contributing factor to sub-standard educational attainment of differing racial groups or social/economic classes in the United States, how much does our current health care financing system contribute?  How much, if any, lost GDP opportunity are we leaving on the table due to suboptimal financing of health care for children K-12?   If, as Dr. Reinhardt argues, health care for this cohort should be a public good, what’s the real GDP return on investment to Dr. Reinhardt’s program?  To me, asking and answering these questions are critically important to advance the policy debate.

via Seriously, What Is a Child? – Economix Blog – NYTimes.com.

Filed under: Bioethics, Health Law, Reform, , , ,

Birds or Pigs; The Swines Have It?

We’ve had a lot of stories the past several days about the swine flu outbreak in Mexico and smaller groupings of confirmed cases in New York, California and elsewhere in the United States.   There has been years of discussion on the H5N1, so called avian flu, pandemic risks.  We all remember the impact of SARS.  And we’ve been rocked, recently, by what some have tagged a ‘depression’ but all of noted as the largest economic downturn since The Great Depression.  The losses associated with this ‘Great Recession’ are still playing out.

But I was wondering — what if the Swine Flu became a pandemic at this time?  All indication (including the CDC site) indicate that aside from some serious implications for Mexico City’s public health, the cases in the United States have been mild, with no hospitalizations.  The 1918 flu pandemic that took 20m lives world-wide, however, is the standard modern example of potential personal and economic costs of a flu pandemic.  Not to minimize the terrible pain and suffering that such a pandemic would cause by putting an economic slant on it– but I was wondering what might be the economic impact to our already tottering United States economy if a pandemic struck.

So I took a look at a study the CDC had commissioned in 1999.  It showed the potential U.S. economic impact of a pandemic.   The CDC used this as a way to assist the public policy discussion in light of strategies regarding flu immunization — i.e., which immunization policy could provide the best net value in the case of flu pandemics of differing severity.   It’s beyond this post (or its author) to analyze the article and it’s conclusions.  But I thought the numbers were notable and summarize the potential economic exposure (without vaccination).  And, of course, this looks at U.S. exposure only.  A pandemic would have a far reach.  Look how quickly in this age of easy travel the virus spread from Mexico to the United States and even potentially exposed the President of the United States during his trip.  From the CDC’s study:

Without large-scale immunization, the estimates of the total economic impact in the United States of an influenza pandemic ranged from $71.3 billion (5th percentile = $35.4 billion; 95th percentile = $107.0 billion) (gross attack rate of 15%) to $166.5 billion (5th percentile = $82.6 billion; 95th percentile = $249.6 billion) (gross attack rate of 35%) (Table 6). At any given attack rate, loss of life accounted for approximately 83% of all economic losses. Outpatients, persons ill but not seeking medical care, and inpatients accounted for approximately 8%, 6%, and 3%, respectively, of all economic losses (Table 6) (Appendix II).

* * * *

If it cost $21 to vaccinate a person and the effective coverage were 40%, net savings to society would result from vaccinating all age and risk groups (Figure 2). However, vaccinating certain age and risk groups rather than others would produce higher net returns. For example, vaccinating patients ages 20 to 64 years of age not at high risk would produce higher net returns than vaccinating patients ages 65 years of age and older who are at high risk (Figure 2). At a cost of $62 per vaccinee and gross attack rates of less than 25%, vaccinating populations at high risk would still generate positive returns (Figure 2). However, vaccinating populations not at high risk would result in a net loss (Figure 2).

via The Economic Impact of Pandemic Influenza in the United States: Priorities for Intervention.

There’s also an interesting Congressional Budget Office (CBO) assessment (and see generally the goverment web page)  of possible economic effects of an avian flu pandemic.  That study concludes that a pandemic involving a highly virulent flu strain (such as the one that caused the pandemic in 1918) could produce an impact worldwide similar in depth and duration to an average postwar recession in the United States — but citing studies ranging from a .5% to 6% decrease in GDP.  Query, of course, what impact if such a pandemic hit during an ongoing recession.

Filed under: Comparative Effectiveness Rearch, Health Law, Personal Posts, Pharmacy, Risk Management, , , ,

Republicans And Universal Health Care (Only Nixon Could Go to China)

Regina Herzlinger (the McPherson Chair at Harvard Business School and author of Who Killed Health Care? (McGraw Hill, 2007); a health care adviser to John McCain’s presidential campaign) writes an interesting op-ed in the Atlantic.  She argues that the Republicans need to seize the moment, realize that the “time for universal health insurance coverage has come” and that they should go to China, figuratively speaking.  “Republicans should…seize the lesson of Nixon’s trip to China”, where in one swoop Nixon brought the middle Kingdom out of isolation and removed the issue from his political adversaries.  [As Spock says in Star Trek VI, there’s an old Vulcan proverb that ‘only Nixon could go to China’ — perhaps only the Republicans can get sustainable health care reform passed?].

Ms. Herzlinger argues that there is a “a massive constituency behind [a potential Republican] policy” and her fellow republicans can do a “better version of universal coverage.”  She highlights challenges with what appears to be the current Democratic plan to rely “on universal coverage through a government-controlled system like Medicare”: (i) distrust government’s ability to apply fiscal controls needed so that any plan would not bankrupt us as Medicare is appearing to do; (ii) concern that the government will control costs by rationing health care to the sick (citing the UK experience with cancer rate survival due to UK’s pathetic approval of new cancer drugs and therapies); (iii) government as a monopolistic buyer of health care could negatively affect the supply of doctors; and (vi) government-controlled system would likely impair the medically and economically important private investment — particularly in the emerging genomic sector.

The Republicans, she argues, should instead offer a “consumer-controlled universal coverage system, like that in Switzerland in which the people, not the government, control how much they spend on health.”  The Swiss choose from 85 private health insurers.  [I believe that the Swiss government causes a degree of plan standardization so that consumers can compare “apples to apples.”]  In Switzerland, the poor shop for health insurance like everyone else, using funds transferred to them by the government.  Rather than the “degraded” Medicaid program, the Swiss poor get the same insurance options that everyone else get.  The Swiss taxing authority, according to Ms. Herzlinger, enforce the mandatory system and achieve 99% enrollment.

This consumer-driven, universal coverage system provides excellent health care for the sick, tops the world in consumer satisfaction, and costs 40 percent less, as a percentage of GDP, than the system in the US. The Swiss could spend even less by choosing cheaper, high deductible health insurance policies, but they have opted against doing so. Swiss consumers reward insurers that offer the best value for the money. These competitive pressures cause Swiss insurers to spend only about 5 percent on general and administrative expenses, as compared to 12-15 percent in the US. And unlike Medicare, the private Swiss firms must function without incurring massive unfunded liabilities. Competition has also pushed Swiss providers to be more efficient than those in the US. Yet they remain well-compensated.

She cautions that the Swiss system is not perfect, we can learn from it.  It maintains some of the same problems we have with fragmented care and poor integration of payments between vertical provider groups for episodes of care.

She concludes by observing that movement to this model will have real economic impacts:

Republicans could enact Swiss-style universal coverage by enabling employees to cash out of their employer-sponsored health insurance. (Although many view employer-sponsored health insurance as a” free” benefit, it is money that would otherwise be paid as income.) The substantial sums involved would command attention and gratitude: a 2006 cash out would have yielded $12,000 — the average cost of employer-sponsored health insurance — thus raising the income of joint filers who earn less than $73,000 (90 percent of all filers) by at least 16 percent. Employees could remain in with an employer’s plan or use this new income to buy their own health insurance.

via Why Republicans Should Back Universal Health Care – The Atlantic Business Channel.

Filed under: Health Law, Reform, , ,

Factors Influencing Physicians Prescribing NAIDs

In his Healthcare Economist blog, Jason Shafrin, Ph.D. (just recieved – congrats) reported on a recent study in The American Journal of Managed Care concerning the prescribing habits of Nonsteroidal Anti-Inflammatory Drug (NAIDs) among physicians.  The study, entitled Pharmaceutical Company Influence on Nonsteroidal Anti-Inflammatory Drug Prescribing Behaviors, describes, through interviews with academic medical center physicians from a variety of specialities, their prescribing habits in order to elicit the general themes that influence their behavior.  As Jason summarizes from the article, they are mostly influenced by the following:

  1. Direct Marketing by pharma detailers.
  2. Patient requests for medication, often driven by direct-to-consumer pharmaceutical advertising.
  3. Habits formed during medical school. Often, these habits are influenced by drug rep visits while the physician was in medical school.
  4. Journals, electronic peer-reviewed literature, and professional meetings.
  5. Local physician expert opinion and practice guidelines.
  6. The physician’s own experience prescribing drugs to patients.

The purpose of the study was to “describe the taxonomy of methods used by pharmaceutical companies to influence physicians’ nonsteroidal anti-inflammatory drug (NSAID) prescribing behaviors and to elicit physicians’ perceptions of and counterbalances to these influences” since there was a recognized poor adherence to prescribing guidelines for NSAIDs.  The study recognized that physicians describe detailing and direct contact with pharmaceutical representatives, requests from patients inspired by direct-to-consumer advertisements, and marketing during medical school and residency training as primary influences.  The study also reports that physicians described practice guidelines, peer-reviewed evidence, and opinions of local physician experts as important counterweights to pharmaceutical company influence.

The study concludes that the “social and communicative strategies used by pharmaceutical companies can be adapted to improve physicians’ adoption of guidelines for safer NSAID prescribing. Communicative interactions between local experts and other physicians who prescribe NSAIDs may be the critical target for future interventions to promote safer NSAID prescribing.”

Aanand D. Naik, MD and Aaron L. Woofter, MD et al,  (2009) “Pharmaceutical Company Influence on Nonsteroidal Anti-Inflammatory Drug Prescribing Behaviors,” Am J Manag Care. 2009 (published online April 1, 2009 and found online April 18, 2009 at http://www.ajmc.com/web-exclusives/managed-care/AJMC_09Apr_Naik_Exclusiv_e9toe15?utm_source=Listrak&utm_medium=Email&utm_term=%2fweb-exclusives%2fmanaged-care%2fAJMC_09Apr_Naik_Exclusiv_e9toe15&utm_content=jshafrin%40ucsd.edu&utm_campaign=AJMC+e-Table+of+Contents+(April+Web+Exclusive)).

via [AJMC] – American Journal of Managed Care.

Filed under: AKS, Conflicts of Interest, Drug Policy, Health Law, Pharmacy, , ,

HHS issues guidance on safeguarding PHI

On Friday, April 18, 2009, the Department of Health and Human Services released its guidance on protecting personally identifiable healthcare information by encrypting or destroying it so that it is rendered “unusable, unreadable or indecipherable to unauthorized individuals.”  (See http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/hitechrfi.pdf).

Because the breach notification requirements of the HITECH Act apply only to breaches of unsecured PHI, the Department’s guidance provides the means by which covered entities and their business associates are to determine whether a breach has occurred to which the notification obligations under the Act and its implementing regulations apply.   Recall that under the HITECH Act, if there is a “breach” of  “unsecured PHR identifiable information” as personal health record (PHR) identifiable health information that is not protected through the use of a technology or methodology specified in the Secretary’s guidance (this document), and the “breach” is not qualified as provided in the HITECH Act, then certain disclosures by the covered entity are required.  These would include direct certified mail disclosure to individuals, “in cases in which there is insufficient or out-of-date contact information, substitute notice, including, in the case of 10 or more individuals for which there is insufficient contact information, conspicuous posting (for a period determined by the Secretary) on the home page of the Web site of the covered entity” and in cases of 500 or more records notice to prominent media outlets within the State or jurisdiction and immediately to the Department.   Notice by covered entities to HHS of all breaches is also required on an annual basis.  The Secretary will also post to its web-site notice concerning all disclosed breaches of 500 patient records or more.

[W]e have identified two methods for rendering PHI unusable, unreadable, or indecipherable to unauthorized individuals: encryption and destruction *** Protected health information (PHI) is rendered unusable, unreadable, or indecipherable to unauthorized individuals only if one or more of the following applies:

a) Electronic PHI has been encrypted as specified in the HIPAA Security Rule by “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key”15 and such confidential process or key that might enable decryption has not been breached. Encryption processes identified below have been tested by the National Institute of Standards and Technology (NIST) and judged to meet this standard.

i) Valid encryption processes for data at rest are consistent with NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices.17

ii) Valid encryption processes for data in motion are those that comply with the requirements of Federal Information Processing Standards (FIPS) 140-2. These include, as appropriate, standards described in NIST Special Publications 800-52, Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations; 800-77, Guide to IPsec VPNs; or 800-113, Guide to SSL VPNs, and may include others which are FIPS 140-2 validated.

b) The media on which the PHI is stored or recorded has been destroyed in one of the following ways:

i) Paper, film, or other hard copy media have been shredded or destroyed such that the PHI cannot be read or otherwise cannot be reconstructed.

ii) Electronic media have been cleared, purged, or destroyed consistent with NIST Special Publication 800-88, Guidelines for Media Sanitization,19 such that the PHI cannot be retrieved.

The Department indicates that its list is an exhaustive list, but it opens discussion of other methods to make PHI unusuable, unreadable, or indecipherable.  In the development of this guidance, the Department reported that it had considered whether PHI in limited data set form should be treated as unusable, unreadable, or indecipherable to unauthorized individuals for purposes of breach notification.  It does not, but suggests that in the future, based upon additional comments and analysis, further restrictions on Limited Data Sets (e.g., removal of some of the digits of ZIP code) might effectively make re-identification such a remote possibility that the more limited data set would be unusable, unreadable, or indecipherable.  The Department also ask for comment on use of fingerprint protected Universal Serial Bus (USB) drives, for example, or whether it should, in providing future guidance on this topic, identify specific “off-the-shelf” products that may “meet the encryption standards identified in this guidance.”

In advance of its guidance to be issued on its interim final regulations on breach notifications, it also asks for comments.  The request for comments seems to indicate that the Department is concerned about need for covered entities to send multiple notices due to inconsistency between federal and state legal requirements.  They also are seeking examples of situations that covered entities think that the exceptions under the HITECH act will actually apply (perhaps to agree, disagree or to use in their own illustrative examples).

1.  Based on experience in complying with state breach notification laws, are there any potential areas of conflict or other issues the Department should consider in promulgating the federal breach notification requirements?
2.  Given current obligations under state breach notification laws, do covered entities or business associates anticipate having to send multiple notices to an individual upon discovery of a single breach? Are there circumstances in which the required federal notice would not also satisfy any notice obligations under the state law?
3.  Considering the methodologies discussed in the guidance, are there any circumstances in which a covered entity or business associate would still be required to notify individuals under state laws of a breach of information that has been rendered secured based on federal requirements?
4. The Act’s definition of “breach” provides for a variety of exceptions. To what particular types of circumstances do entities anticipate these exceptions applying?

Filed under: Health Law, HIPAA, , , ,

PartnersHealthCare Announces Industry Relationship Policy

The WSJ Health Blog in its April 10, 2009 posting reported that Parterns Healthcare, which includes Harvard-affiliated Mass General, had issued a report recommending tighter restrictions on industry relationships with its physicians.

The news release by Partners listed key recommendations from its report:

Prohibition of all gifts, including meals and funding for meals, provided directly to staff by industry for their personal use, on a Partners site or off site. This ban also applies to Partners institutions accepting industry gifts for this purpose.

Development of mechanisms to have free drug samples distributed only through the hospital pharmacy or some other centralized system, and not provided directly to or distributed by physicians.

Requiring that industry representatives have written invitations defining the purpose and terms of visits before having access to Partners sites and staff.

Establishment of a process to identify and manage significant financial interests held by physicians in companies that make products they prescribe or use in their practices.

Acceptance of industry funding for educational programs and fellowships only if provided through a centrally pooled institutional President’s Fund at each hospital or approved by a newly-created, Partners-wide Educational Review Board.

Establishment of a robust, tiered approach to evaluate research-related conflicts of interest, including continued prohibition of certain high-risk circumstances.

Adoption of a stricter policy holding certain officials to a higher standard because of their influential positions within the organization.

Strengthened oversight of permitted outside activities, including a ban on faculty participation in industry speakers bureaus, an express prohibition on faculty being listed as authors on papers ghostwritten by others, and a more rigorous internal review process for certain outside activities.

Development of an enhanced infrastructure, including creation of a new Conflict of Interest Review Committee, responsible for education, oversight, and enforcement of Partners policies and practices in regard to industry interactions.

The system plans to adopt revised policies and procedures by October 1, 2009 and acknowledges that a significant training and education program will be necessary during the roll-out of these changes.  The 30 page report details the commissions charge, its process, its internal review, external factors and recommendations. The press release link is below.

CommissionPressRelease_PartnersHealthCare2009.pdf (application/pdf Object).

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Researcher Faked Data in Sleep Apnea Study – Health Blog – WSJ

The WSJ Health Blog reports another individual fabricating research study data.  Not much about industry ties, except that he later went on to work in industry.

“Robert Fogel, a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients, the Office of Research Integrity at HHS said…Fogel, who worked at Brigham and Women’s Hospital at the time but later moved on to work at Merck, told a former supervisor in 2006 that he had falsified the data, the Scientist reports.”

via Researcher Faked Data in Sleep Apnea Study – Health Blog – WSJ.

Filed under: Conflicts of Interest, Health Law, , , ,

Hospital Gets Subpoena Tied to Doctor’s Studies – WSJ.com

The WSJ and its WSJ Health Blog report that Baystate Medical Center has been subpeoned for records related to Scott S. Reuben, a Massachusetts doctor accused of faking data used in at least 21 anesthesiology studies.  The accused physician, was also on the faculty of Tufts University medical school.

Some of his research was funded by Pfizer Inc., Wyeth and Merck & Co., Wyeth said it provided $10,000 in grant money to Dr. Reuben from 2001 to 2003.  According to the WSJ Health Blog, Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.

via Hospital Gets Subpoena Tied to Doctor’s Studies – WSJ.com.

Filed under: Compliance Programs, Conflicts of Interest, Health Law, ,

Johns Hopkins Bans Free Drug Samples, Gifts from Industry – Health Blog – WSJ

As reported in the April 8, 2009 WSJ Health Blog, John Hopkins is the latest to adopt a restrictive policy on ‘on interaction with industry.’  the new policy “bans free drug samples and says doctors can’t participate in consulting gigs in which they’re essentially paid for not doing anything…”  The ban “applies to Hopkins’s medical school, hospitals and clinics”.   It also “prohibits gifts, entertainment or food — regardless of value — from drug and medical device companies.”

As for consulting relationships, the policy says that payments that are “without commensurate associated duties are considered gifts and are prohibited.”

According to the Health Blog, Hopkins representatives do not “believe it has a problem with …’sham’ consulting arrangements, but they’ve been a subject of concern around the country.”  For there doctor’s sake, one would hope not since that might be a bit more problematic than a meal or gift, no?

From the policy:

[On Gifts:]To avoid the risk of conscious or subconscious bias in decision-making, it is the Johns Hopkins Medicine policy that faculty and staff, employees, students, trainees, and volunteers may not accept gifts or entertainment (see below for food and meals), regardless of value ***

[On Consulting Arrangements:] Consulting arrangements involving personal compensation without commensurate associated duties are considered gifts and are prohibited. Specific policies regarding outside consulting are set forth in the School of Medicine’s policy on conflict of commitment and in JHM organizations’ personnel policies. ***

[On Food/Meals]: With certain exceptions, outlined below, industry-supplied food and meals are considered personal gifts and will not be permitted and may not be accepted at any JHM member organization site, in connection with activity conducted under the auspices of or using the name of any JHM member organization or in the context of professional activity off-site. ***

[On Unrestricted Gifts to Instituti0n:] Through unrestricted gifts, industry generously supports the educational, research, and patient care missions of Johns Hopkins. Gifts must be made to the University or JHHS and deposited in a departmental account.  There may be no quid pro quo, nor any limitations nor conditions placed on gifts that are inconsistent with Fund for Johns Hopkins Medicine policies and applicable regulations.***

[On Samples:] The practice of accepting free pharmaceutical samples risks interference with one’s prescribing practices since industry representatives often provide the newest and most costly drugs. Therefore, free pharmaceutical samples and vouchers for free pharmaceutical samples may not be accepted.***

[On Access by Pharma Reps:] [A]ccess by pharmaceutical, medical testing and other industry representatives to individual physicians must be restricted to non-patient care areas. Access will be permitted only on invitation from a physician, nurse, pharmacist, respiratory therapist, or other professional healthcare staff member.***

[On Speaking Gigs:] Faculty members may speak at an industry-sponsored program only if the faculty member retains full control and authority over professional material the faculty member presents and does not allow such communications or presentations to be subject to prior approval by any commercial interest other than approval for the use of proprietary information.

via Johns Hopkins Bans Free Drug Samples, Gifts from Industry – Health Blog – WSJ.

Filed under: AKS, Compliance Programs, Conflicts of Interest, Health Law, , ,

The New Tarasoff? 6th Circuit OKs Hospital Suit Over Ax-Wielding Ex-Patient | ABA Journal – Law News Now

In Moses v. Providence Hospital and Medical Ctrs the Sixth Circuit federal court of appeals finds that the Emergency Medical Treatment and Active Labor Act (“EMTALA”), 42 U.S.C. § 1395dd gives hospitals a duty to third parties concerning patients that are admitted and then not appropriately treated and stabilized for a mental illness who later go on to harm the third party.  In Moses, a husband presents to the hospital emergency room with his wife, having severe headaches, muscle soreness, high blood pressure, vomiting, slurred speech, disorientation, hallucinations and delusions.  According to his wife he is demonstrating threatening behavior.  The man is clearly screened, although there is a dispute as to whether the physician involved concluded that the husband had an emergency medical condition.   He was admitted for testing and observation.  He was discharged four days later.  There is some evidence in the record that he was to be admitted to the psych unit, although other evidence suggest he had medically stabilized and desired to leave, although the wife was still afraid of him.  The husband, ten days after his discharge, killed his wife.

The defendant hospital’s case is dismissed in summary judgment at the district level.  The hospital contends that (1) the defendant lacked standing because only the individual patient who seeks treatment at the hospital has standing under EMTALA; and (2) that EMTALA imposes no further obligation on a hospital once the hospital has admitted a person as an inpatient.

The court, discounting some legislative history as not controling, and other judicial decisions that have held that relatives of individuals do not have standing, says that a plain reading of the statute requires that any individual who suffered an actual personal injury due to the EMTALA violation may bring a claim against the hospital.  Because this is a third party that suffered actual person injury by the hospital’s allged injury, the court did not think that Zeigler v. Elmore County Health Care Auth., 56 F. Supp. 2d 1324 (M.D. Ala. 1999) (looking to the legislative history of EMTALA, holding that a mother cannot maintain an EMTALA action for a violation related to her daughter’s medical condition) was on point.  The court acknowledges that “our interpretation of the civil enforcement provision may have consequences for hospitals that Congress may or may not have considered or intended. However, our duty is only to read the statute as it is written, as we have in our past analysis of EMTALA.”

The court also holds that the hospital’s obligations do not end upon admission of the patient as an inpatient.  This can be a thorny issue for hospital, but most hoped with the Centers for Medicare and Medicaid Services (“CMS”) new rules,  a hospital’s EMTALA obligations upon admitting an individual as an inpatient. 42 C.F.R. § 489.24(d)(2)(i).  The Moses court acknowledges that the rules state that “[i]f a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual.”  But the Moses court finds that this does not support the summary judgement because it was (1) enacted after the cause of action accruing in this case, and, more importantly (2) “[t]he CMS rule appears contrary to EMTALA’s plain language, which requires a hospital to ‘provide . . . for such further medical examination and such treatment as may be required to stabilize the medical condition[.]'”  The court pretty much lays down the gauntlet to hospitals: “a hospital may not release a patient with an emergency medical condition without first determining that the patient has actually stabilized, even if the hospital properly admitted the patient.”

This is a particularly remarkable case.  The allusions to the famous Tarasoff case may be overly broad — but I am sure there will be much more written about it.

Filed under: CMP, EMTALA, Health Law, , , ,

Health Law Reporter – Economy Increases False Claims Risk, Requiring Greater Focus on Compliance

In the most recent BNA Health Law Reporter, Health Law Reporter. 18 HLR 387, there was an article opining that harder economic times increases FCA qui tam and, in general, healthcare compliance risks.  I found the following notable summary of reasons that compliance programs do not work as well as intended (taken from the BNA article, which, in turn takes from a February 11, 2009 presentation to the AHLA by Patrick S. Coffey, Chris J. Mollet, University of Illinois at Chicago, and Linda A. Wawzenski, assistant U.S. attorney for the Northern District of Illinois):

• Compliance is not a business priority;
• Programs do not operate as written and do not focus on heading off claims;
• Employee training is dull and ineffective;
• There is a lack of ongoing and meaningful risk assessment;
• Hotlines are not sufficiently promoted;
• Employees do not trust the compliance commitment so do not report concerns, while managers do not understand why this is so;
• Significant enforcement settlements are ignored or quickly forgotten;
• Organizations are not prepared to handle internal investigations and routinely mishandle internal reports;
• Disgruntled employees are dismissed and whistleblowers are not protected; and
• Difficult economic times are allowed to undercut compliance efforts.

Filed under: AKS, CMP, Compliance Programs, Fraud and Abuse, Health Law, Physician Self Referral/Stark, Risk Management,

Finding a Doctor Who Accepts Medicare Isn’t Easy – NYTimes.com

A New York Times article on April 1, 2009 discusses some trends: (i) a national shortage of internists, (ii) more internists and other primary care physicians refusing to accept Medicare entirely or at least new Medicare patients, and (iii) boutique/concierge  medicine.

On the first two points:

[T]he American College of Physicians, the organization for internists, estimates that by 2025 there will be 35,000 to 45,000 fewer than the population needs — and internists are increasingly unwilling to accept new Medicare patients. In a June 2008 report, the Medicare Payment Advisory Commission, an independent federal panel that advises Congress on Medicare, said that 29 percent of the Medicare beneficiaries it surveyed who were looking for a primary care doctor had a problem finding one to treat them, up from 24 percent the year before. And a 2008 survey by the Texas Medical Association found that while 58 percent of the state’s doctors took new Medicare patients, only 38 percent of primary care doctors did.

On the last point:

Another, more expensive option is concierge or “boutique” care, which comes in two forms. In the most popular kind, doctors accept Medicare and other insurance, but charge patients an annual retainer of $1,600 to $1,800 to get in the door and receive services not covered by Medicare, like annual physicals. Before signing up and paying the retainer, patients should get a written agreement spelling out which services the doctor will bill Medicare for and which the retainer covers. And always check carefully for double-billing…The other form of concierge medicine — doctors who have opted out of Medicare — is more expensive still. Fees range as high as $15,000 a year and cover office visits, access to the doctor when care is needed, referrals to specialists and thorough annual physicals…Dr. Knope, the author of “Concierge Medicine: A New System to Get the Best Healthcare,” has this kind of practice in Tucson. His patients sign a contract agreeing to pay $6,000 a year for individuals and $10,000 a year for couples. The fee covers office visits, physical exams and phone consultations, and Dr. Knope will meet patients in the emergency room, see them in the hospital and occasionally make house calls…A list of about 500 concierge doctors throughout the country is available on Dr. Knope’s Web site, http://www.conciergemedicinemd.com.

via Finding a Doctor Who Accepts Medicare Isn’t Easy – NYTimes.com.

Filed under: CMP, Concierge Medicine, Health Law, Medicare, Payment, Primary Care, Reform, , , ,

Stanford Medical School to Disclose More About Industry Comp – Health Blog – WSJ

According to the April 1, 2009 WSJ Health Care Blog, Standford is to publicly disclose on its web-site those of its medical school faculty receiving industry money greater than $5,000 — although specific amounts will not be disclosed.

Stanford University’s medical school said today it expects to post an online list by the end of the summer showing its staff members who received payments, royalties, stock grants and other compensation topping $5,000 in 2008. Companies providing the compensation to each staff member on the list will be identified but the dollar amounts staffers received above $5,000 won’t be included. Among the targets of the Grassley’s investigations was Alan Schatzberg, who chairs Stanford’s psychiatry department.

via Stanford Medical School to Disclose More About Industry Comp – Health Blog – WSJ.

Filed under: Conflicts of Interest, Health Law, Reform, Risk Management, , ,

The Health Care Blog: “Mr. Obama, Tear Down These (Hospital) Walls”

On the Healthcare Blog, Rober Wachter analyzes the recent NEJM report on hospital readmissions, the related

[T]he DRG system created a big black hole, and it is time to fill it. It’s called the post-discharge period. And one large part of the detritus emerging from that hole is readmissions. You probably saw this week’s NEJM study by Stephen Jencks (a former Medicare official and now a Baltimore-based consultant), and my pals Mark Williams and Eric Coleman, of Northwestern and Colorado, respectively. The study found that 20% of Medicare patients are readmitted within a month of discharge, and one-third return within 90 days. Even more remarkably, by a year out more than half of patients (56%) discharged from an acute care hospital are re-hospitalized. The authors estimate that the cost of preventable readmissions was $17 billion in 2004 (the study year), which would make it more like $25 billion today.

via The Health Care Blog: “Mr. Obama, Tear Down These (Hospital) Walls”.

Wachter also summarizes some interesting points of the study:

Like so many things in healthcare, there was striking geographic variation in readmission rates – from a low of 13% in Idaho to 23% in Washington, D.C.

There were also variations by DRG, with the highest readmission rates in patients with heart failure, psychosis, vascular and cardiac surgery, and COPD – pointing the way toward targeted interventions.

More than half the patients readmitted within 30 days appeared not to have had an outpatient visit between hospital discharge and readmission, perhaps another target for intervention.

Most (70%) surgical patients who are readmitted come back for a medical diagnosis such as pneumonia or UTI.

Approximately 30% of readmitted patients come back to a different hospital, so hospitals will underestimate the extent of their readmission problem by looking solely at their own bounce-backs.

via The Health Care Blog: “Mr. Obama, Tear Down These (Hospital) Walls”.

Wachter continues and and discusses why this is becoming critical (healthcare reform/savings dollars) and the health system’s current state as it relates to discharge planning/readmissions:

The Obama budget plan depends on figuring this out. The budget, which aims to save $300 billion (which used to seem like a lot of money) in Medicare/Medicaid costs over the next decade, includes a projected $26 billion in savings from “driving down hospital readmission rates for Medicare patients” …The manifestations of this myopic focus on hospitalization as the unit of analysis can be seen in the paucity of attention that hospitals give post-discharge care. Studies have chronicled a litany of post-discharge disasters…In other words, when it comes to post-discharge care, we suck…Despite powerful literature that shows that simple interventions – like post-discharge phone calls or the use of a transitions coach – can lead to impressive improvements in post-discharge care and decreased readmission and return-to-ED rates, few hospitals have put these interventions in place.

Wacther then makes an observation concerning financial efforts to address the system’s performance in this area:

Harvard’s Arnie Epstein reviews the policy initiatives addressing readmissions – including those that are here today (publishing readmission rates on the Web) and those being actively discussed (financial penalties to hospitals with high readmission rates). But the Cool Kid on the Payment Block is “bundling” – aggregating  payments for doctors and hospitals for a period of time after an illness (an “episode of care”) in an effort to create accountable integrated entities that will improve care across the continuum (the entities somehow have to split up the spoils between hospitals, hospitalists, SNFs, primary care docs, specialists, care coordinators… Have fun with that). Epstein’s verdict: worthy of pilot studies, but “the likelihood that [bundling] will prove to be a successful model is still uncertain.”

He recognizes the challenges, and the laments, of hospitals, that have difficulties in controlling other healthcare provider’s post-discharge data.  Why, hospitals ask, can you hold us responsible if we are not in control of this.

I would also put on the table that if the government goes this route, query if it makes any sense to maintain Medicare CoP restrictions on promotion of hospital/health system owned and controlled providers — such as those exist for home health.

He observes that there are tools ready out there to assist hospitals in this area, including those developed through the Society of Hospital Medicine and its “splendid” Project Boost.

Finally, he observes that “I, like you, don’t know where the money will come from for all of this.”   I tend to disagree.  I pretty much know where (most of) the money will come from — where the largest portion of the Medicare premium dollar comes from — inpatient admissions.   Get ready!

Filed under: Comparative Effectiveness Rearch, Health Law, Medicare, Payment, Quality Reporting, Reform, Risk Management, , , ,

Doctors Urge End to Corporate Ties – NYTimes.com

The NY Times Health Blog on April 1 reports that JAMA published a paper in its April 1, 2009 edition.   The paper recommends that medical professional associations adopt stricter conflict-of-interest guidelines.  Mere disclosure of financial ties to drug and medical device companies is not sufficient.  They also advocate barring members industry financial ties from entering leadership positions and participating in influential committees within the association.

The blog further reports that:

The authors are particularly adamant that professional medical associations should neither accept corporate money to underwrite the development of practice guidelines nor allow members with financial ties to industry to serve on committees that develop the guidelines, which are usually widely adopted as the gold standard for medical practice. … “The consensus here was quite clear: You do not want the piper calling the tune,” said David J. Rothman, a professor of social medicine at Columbia University. “We ask that these groups make every effort to get to zero percent and, knowing that it is very difficult to do that, that they move as rapidly as possible to no more than 25 percent,” referring to how much of their support should come from industry.

Commentary from Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America was also reported in the blog, reminding of the amount of money that industry provides for necessary research and other support of healthcare providers.

“The vast majority of the research is funded by pharmaceutical companies,” Ms. Powell said. Important decisions regarding practice guidelines might be made, she said, by “very junior people who have no experience.”

via Doctors Urge End to Corporate Ties – NYTimes.com.

Note a similar post in the WSJ Health Blog.

Filed under: Conflicts of Interest, Drug Policy, Health Law, Pharmacy, Reform, , , ,

Authors of Psychiatric Guidelines Get Funding from Drug Makers – Health Blog – WSJ

The WSJ Health Blog reports a significant portion of those writing the APA’s treatment guidelines have financial ties to industry.

[A]mong 20 authors of the guidelines for treatment of depression, dipolar disorder and schizophrenia, 18 had at least one financial tie to a drug maker, and 12 had ties in at least three categories, such as consulting, research grants, speaking fees or stock ownership.The guidelines are a powerful influence on the way doctors treat patients. This week, big-name docs argued in a JAMA paper that medical specialty groups, which put out the guidelines, should tightly limit their funding from industry. (Drug trade group PhRMA responded that industry funding helps doctors obtain important medical information.) Earlier this year, amid news that many heart-disease guidelines aren’t backed up by rigorous scientific testing, an editorial in JAMA argued that guidelines “often have become marketing tools for device and pharmaceutical manufacturers.”

via Authors of Psychiatric Guidelines Get Funding from Drug Makers – Health Blog – WSJ.

In the referenced Boston Globe article one of the authors Dr. Roy Perlis, after noting that the guidelines in his area promote generics and non-pharmeceutical interventions states:

“My job is to find better treatments for my patients. These are awful illnesses. People really suffer,” he said. “And the people who are most responsible for developing new treatments right now are the pharmaceutical companies. What is being lost in all this is that if I didn’t work with them, I couldn’t do my job as a scientist – the part of my job that says we have people who are suffering that need new treatments.”

Filed under: Conflicts of Interest, Health Law, Pharmacy, Reform, Risk Management, , , ,

Hospital Doors Revolve for Many Medicare Patients – Health Blog – WSJ

The WSJ Health Blog reports on April 2, 2009 that MEDPAC is recommending restructuring hospital payments in a “bundle” to incentive hospitals to minimize readmissions of Medicare patients.  We’ll see how this plays out, but I can certain envision greater integration of bundled prospective payments for, at least, certain types of admissions.

Some 20% of Medicare patients discharged from the hospital are readmitted within a month, and 34% return within three months, according to a study published in the current New England Journal of Medicine. Unplanned rehospitalizations cost Medicare $17.4 billion in 2004, the study says…MedPac, a commission that advises Congress on Medicare policy, has recommended that Medicare start a pilot program in which “bundled” payments extend beyond the first hospital stay to include, say, the first 30 days after discharge. The idea, which is also part of President Obama’s budget proposal, is that if hospitals get paid fixed rates for caring for certain conditions — and they don’t get paid more for those same conditions if patients return — hospitals will have a financial incentive to reduce the risk of readmission.

via Hospital Doors Revolve for Many Medicare Patients – Health Blog – WSJ.

Filed under: Comparative Effectiveness Rearch, Health Law, Medicaid, Medicare, Payment, Quality Reporting, Reform, , , ,

Colwell v. HHS, 9th Cir.

Colwell v. HHS, 9th Cir., No. 05-55450, 3/18/09

In a March 18, 2009 decision, a federal court refused to rule on whether, by issuing “Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons” is a violation of the Administrative Procedure Act.  The court refused to entertain the claim, finding that it was not yet ripe as HHS had not used it for enforcement.   In general the APA requires rules to follow a public commentary process.  A summary can be found in the Health Law Reporter, 18 HLR 408.

Filed under: Health Law, Primary Care, Risk Management,

JAMA Sets New Policy in Wake of Disclosure Flap – Health Blog – WSJ

There seems to be a conflicts of interest fight brewing between JAMA, a professor of neuro-anatomy and BMJ.  According to WSJ Health Blog, “Leo, a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn., faced criticism from editors at the Journal of the American Medical Association when he published a letter in another medical journal, BMJ, that highlighted an unreported conflict of interest in a study published by JAMA…The editorial… scolds Leo for publishing his letter in the BMJ before JAMA weighed in on the matter. In addition, the editorial says JAMA contacted the dean at Leo’s medical school in an attempt to apply pressure from above…As a result of the flap, JAMA says it is adopting a new policy under which anyone asserting that study authors have failed to disclose conflicts of interest should keep the matter confidential until JAMA investigates… That move is already generating controversy.”  What I find interesting is (1) apparently, the discovery of the potential conflict arose when Dr. Leo questioned material omissions in the study; (2) JAMA apparently contends that it is inappropriate for a third party to write about an apparent undisclosed conflict until JAMA has done its own thorough investigation and reported back; (3) apparently all this disagreement devolved into some name calling.   Interesting reading.

Read the JAMA editorial at http://jama.ama-assn.org/misc/jed90012pap_E1_E3.pdf

Read the Dr. Leo’s WSJ statement at http://online.wsj.com/public/resources/documents/leo_statement_for_WSJ.htm

Read the BMJ letter at http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503

via JAMA Sets New Policy in Wake of Disclosure Flap – Health Blog – WSJ.

UPDATE.  In the March 30, 2009 WSJ, WSJ reports that the American Medical Association (which controls JAMA) has appointed an oversight committee to investigate charges that the top editors threatened a researcher who publicly faulted a study in the publication. via Medical Group Seeks Probe of Its Journal – WSJ.com.

Filed under: Conflicts of Interest, Health Law, , ,

The Washington Independent » Rick Scott on His Health Care Record

The NY Times did an article on Mr. Rick Scott recently. Also of note, The Washington Independent interviewed Rick Scott on March 31, 2009.  You’ll recall him as the ousted CEO of Columbia/HCA after their trillion dollar fraud settlement with the federal government.  He’s back in the headlines as a ‘conservative’ voice against a potential Obama healthcare reform initiative.  I note only due to his comments on Columbia/HCA at the time.

RICK SCOTT: There’s no grudge. First off, if you go back and look at what we accomplished at Columbia/HCA, it was the lowest prices and best outcomes. I left and nothing happened to me. I can’t do anything about what people want to complain about. But if you look at what we’re doing, we’re doing the right things.

TWI: What, specifically?

RICK SCOTT: If you go look at Solantic [which Scott co-founded in 2001], we have transparency on prices, we’re dramatically less expensive than everyone else and we have a great service. Or go back and look at Columbia, look at all the objective measures. Go look at joint commission, accommodation, at accreditation. If you look at the top 100 hospitals, we started with less than seven percent of them. My last year, we had 27 percent of those hospitals. If you look at my management team, all of my management team went on and ran hospital companies.

TWI: People can still say, “Look, this was the guy who resigned in the biggest fraud settlement in American history.”

RICK SCOTT: But, you know, we were the biggest company. If you go back and look at the hospital industry, and the whole health care industry since the mid-1990s, it was basically constantly going through investigations. Great institutions, like ours, paid fines. It was too bad.

via The Washington Independent » Rick Scott on His Health Care Record.

Filed under: AKS, CMP, Drug Policy, Executive Compensation, Health Law, Reform, Risk Management, , ,

Healthcare Economist · Comparison of Pharmacists and Primary Care Providers as Immunizers

In his Healthcare Economist blog, Jason Shafrin writes about a recent paper he wrote with John Fontanesi, Jan Hirsch, Sarah Lorentz, and Debra Bowers and had published in American Journal of Pharmaceutical Benefits.  The paper (which I have not reviewed) analyzes the efficacy and quality of immunizations as provided in primary care offices and pharmacies in California.  The abstact is below and observes that from a consistency, cost and productivity stand point, pharmacies might be a better alternative. 

This study examines the potential role of “alternative community immunizers,” specifically pharmacists, in providing immunization services. A convenience sampling of almost 700 adults eligible for vaccinations was taken from 15 ambulatory care settings and 11 pharmacies in San Diego, California between 2006 and 2008. The results of the study found that patient characteristics and beliefs were similar between primary care and pharmacies, but pharmacies proved more consistent in following safety protocols; had lower unit costs; and were more efficient, with greater productivity. We conclude that pharmacies combine the best immunization practices of routine scheduled primary care visits and mass influenza vaccination clinics, but gaps still exist in pharmacies’ ability to effectively transmit immunization records securely and provider willingness to embrace these “alternative immunizers.“

via Healthcare Economist · Comparison of Pharmacists and Primary Care Providers as Immunizers.

Filed under: Comparative Effectiveness Rearch, Drug Policy, Health Law, Pharmacy, Primary Care, Quality Reporting, Reform, Risk Management, , ,

A Lesson on Health Care From Massachusetts – NYTimes.com

In the March 28th NYT:

In any effort to restructure American health care, two interconnected goals inevitably compete for primacy. One is providing health coverage to the uninsured…The other is slowing the relentless and unsustainable growth of health costs…President Obama[‘s] …positioning suggests he has put cost first…. Mr. Obama’s strategy is to sell the expansion of access — largely through public insurance programs — as inseparable from serious efforts at innovation and restraint…[T]he lawmakers and strategists behind the Massachusetts plan strongly defend their incremental approach. Only by deferring the big decisions on cost containment, they said in recent interviews, was it possible to build a consensus among doctors, hospitals, insurers, consumers, employers and workers for the requirement that all residents have health insurance.

“The [Massechusetts] concept,” Mr. Kingsdale said, “[was] to sequence reform in some way to do the really hard thing, which is expanding access, before we do the nearly impossible thing, which is containing costs. [For the US] don’t want to end up holding 50 million uninsured hostage to cost containment.” ***Massachusetts did not create [a government sponsored] plan [such as being floated by the Obama administration], choosing instead to offer subsidies that make commercial policies more affordable. Diane Archer, co-director of the Health Care for All Project at the left-leaning Institute for America’s Future, questioned whether that put enough competitive pressure on insurers. “If we want to bend that cost curve down, it’s through the public option that we’re going to do it,” she said. …. Although health reformers in Massachusetts acknowledge that the fiscal and political landscape in Washington is profoundly different, there is broad agreement among them about the importance of mandating coverage for adults. The insurance lobby has said that if Washington required coverage for all, it would end the practice of denying coverage to those with pre-existing health conditions. …If history is a guide, the success of health reform may depend on whether the White House and Congress can give interest groups enough to keep them on board.

via A Lesson on Health Care From Massachusetts – NYTimes.com.

Filed under: Health Law, Reform, , ,

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