The good news: the media have done a reasonably good job of getting the word out to consumers of healthcare with respect to the prevention of medical and surgical mistakes in acute care settings. The bad news? Here in Minnesota, the numbers of “wrong surgeries”, a collective term meaning never-events in this care realm, topped 2010′s tally by five cases — creating a surge in such cases last year.

The figure is the highest in eight years of self-reporting by Minnesota hospitals. Officials cited many reasons for the mistakes — from doctors filling out incorrect orders to sloppy inventories that make it easy to grab the wrong joint implants for orthopedic procedures.

While the surge appears to be from the absolute numbers of incorrect procedures performed, the rate of adverse events has globally decreased, bringing into question the efforts of many healthcare systems in the processes involved in preventing completely avoidable lapses in care delivery. | LINK

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The cost of the delivery of healthcare in this country always seems to be independent of traditional models of demand in practically any other market-based, for-profit operation. That is, instead of relying on the parameters of patient (consumer) satisfaction or dissatisfaction; further innovation fuels the development of costlier, more advanced technology seemingly designed to break the bank (in one way or another) the very entity it is supposed to benefit: the patient.

An editorial reprint in today’s Minneapolis-St. Paul paper of record, the Star Tribune, makes the case for the unintended costly consequences this very innovation has on the big picture with respect to healthcare delivery in the 2010s. It focuses on the use of nuclear diagnostics developed by the Mayo Clinic as a superfluous and disruptive innovation which does the patient-as-consumer no favors…while benefiting the institution at the hands of government abetting.

Proton beam therapy is a kind of radiation used to treat cancers. The particles are made of atomic nuclei rather than the usual X-rays, and theoretically can be focused more precisely on cancerous tissue, minimizing the danger to healthy tissue surrounding it. [...]

To generate sufficient revenue, proton beam facilities need to treat patients with other types of cancer. Consequently, they have been promoted for patients with lung, esophageal, breast, head and neck cancers.

But the biggest target by far has been prostate cancer, diagnosed in nearly a quarter of a million men each year. [...]

With Medicare reimbursement so generous, and patients and doctors eager for the latest technology, building new machines is sane, profitable business for hospitals like Mayo.

But it is crazy medicine and unsustainable public policy.

Maybe so, but the practice of medicine depends upon the richness of technologies in which parties not only compete toward developing paths of effective treatments for chronic diseases (like cancer, in this case), but also race to spur further research on the nature and behavior of disease. It is within this self-fulfilling prophecy of the cycle of medical education that knowledge moves forward — something the creators of publications like this one thrived upon. And, that’s a good thing. | LINK

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After a two-year investigation into disclosure issues surrounding a top University of Minnesota physician faculty member, the case is now closed — accompanied by a stern “cautionary letter” which

instructed him to take corrective measures to prevent further problems, but decided against further disciplinary action. A review committee found no evidence of fraud or misrepresentation. However, the committee found that Polly failed to sufficiently disclose the Medtronic relationship in connection with two medical journal publications and a conference presentation.

He no longer does work which requires scrutiny for disclosure since the investigation’s launch in November 2009. | LINK

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In an effort to track physician referral patterns, some hospital systems are resorting to detailing to increase revenue. Much like the pharma reps hired by their respective companies back in the day, hospitals are hiring these paid ambassadors — many former pharma reps – to trumpet favorable care data in order to buffer the bottom line. Hospitals say they are doing this to better streamline care — especially among providers who split referrals among hospitals, thereby cutting administrative waste in this regard. Proponents call these detailing visits to primary care offices liaison-like – initiatives allowing providers a voice from beyond the hosptial arena in an affort to enhance patient care quality. They are also quick to point out that hiring former pharma reps displaced by shrinking sales, fewer NDAs, increased generic availability, and general prohibition of access by reps by healthcare orgs only benefits the economic sector in a flailing economy.

Hospitals say their new sales approach is part of a broader strategy to develop closer ties to physicians, who largely determine where patients go for care. Hospitals also are buying doctors’ practices or forming closer partnerships with physicians to improve care and drive admissions.

Like it or not, healthcare delivery is an industry in this country. In one sector in which market share is showing a tremedous decline, there jumps in another opportunity to create new platforms for innovation. As long as no antitrust issues occur, there should be room for the experimentation of new avenues to enhance quality of care delivery. As the components of care delivery (ambulatory versus inpatient, for example) become more specialized in their own right, it will be interesting to observe this effort by hospitals to grow and innovate in an increasingly crowded healthcare marketplace, allowing regulation by government entities only if patient care is truly at risk. | LINK

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As a follow-up to a DP post on the unusual strategy pharma company Pfizer is implementing in trying to protect market share for the formerly solely branded drug Lipitor, here’s another take on the issue. According to one analyst profiled, Pfizer faces an uphill battle in trying to convince the pharma marketplace that its branded agent is more clinically efficacious than generic atorvastatin.

Pfizer is doing a so-so job of convincing health plans and [pharma benefit managers] that Lipitor is somehow better than a generic. On a scale of 1 to 10, Pfizer received a 4. Nonetheless, 54.8 percent say they will offer the authorized generic, which is being sold by Watson Pharmaceuticals. Meanwhile, only 30.4 percent report they will receive added rebates or discounts from Pfizer.

Of course, the pharma company stands to lose a ton during its loss of exclusivity over the next 6 months, but it will remain tenacious — as many analysts do not believe future antitrust issues will occur. Perhaps even more interesting is the new ground being broken here: can healthcare consumers be weaned off of generics and stay loyal to branded medications — if insurers and key third parties allow them to gain incentives by continuing to utilize them? | LINK

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Twenty-eleven and 2012 are going to be remembered in the near term as very profitable periods of the generic manufacture of many formerly branded mega-sellers. Of course, the agent getting the most media ink this week is atorvastatin (Lipitor), the ubiquitous cholesterol lowering pill whose miraculous ways even prompted a short-lived lobby to go OTC.

The pharma company Pfizer, it could be reasoned, would still have some skin in the game in spite of generic availability. Specifically, partnerships with pharma benefit managers and insurers would still give the company a stake in orgs that would inhibit generic availability by offering rebates and discounts of branded Lipitor. It is the potential for actions like this which gets the attention of legislators (specifically Democrats) who want fair competition — as opposed to stymied innovations in generic marketing from pocketed profits by PBMs and insurance companies.

Detailed in an NYT piece last month, the prospect for limited availability of generics — specifically for Medicare Part D beneficiaries is a sobering one. Pfizer claims cost equivalencies (with respect to lower co-pays on branded Lipitor) for beneficiaries if the pharma company is able to offer those discounts to third parties. It is an interesting development in what is usually an uneventful and mundane process.

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This item comes as no surprise to those of us who primarily treat the elderly.

According to researchers, nearly 100,000 hospitalizations every year are linked to adverse drug events such as allergic reactions and unintentional overdoses. Nearly half, or 48.1 percent, of those hospitalized were adults 80 years old or older.

Those agents? Insulin, older generation anti-diabetic drugs (oral), aspirin, and warfarin. It is quite true — and as equally disturbing — that these medications are not only responsible for discrete adverse drug reactions in their own right, but their pharmacological behaviors are responsible for a substantial number of interactions whose iterative clinical manifestations are truly logarithmic in scope. | LINK | Abstract LINK

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The DOJ decision has been handed down. Merck Co. will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It also will plead guilty to a misdemeanor charge stemming from the premature marketing of the market-recalled drug targeted to treatment of rheumatoid arthritis, usurping FDA approval for that indication.

Merck agreed to pay an undisclosed sum to the states of Florida, New York and South Carolina to resolve suits alleging the drug maker failed to adequately warn patients of Vioxx’s risks before halting sales in 2004, Russ Herman, a lawyer for former users of the drug, said in the Nov. 10 filing.

For those who have already forgotten, Vioxx was yanked from the pharma marketplace in 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007, three years later, the company paid $4.85 billion to settle approx. 50,000 Vioxx-related lawsuits. | LINK

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The president will issue an executive order today requiring the FDA to act on potential drug shortages in the phrama marketplace. Previously, drug companies were only required to notify the agency if a preparation was to be discontinued. Any other notification would be completely voluntary on the part of the manufacturer. The executive branch action is only the latest maneuver^[1] by this administration to “get tough” in the way of roadblocks initiated by the GOP in the legislature to nix his jobs bill en toto.

Most preparations affected are used in the aucte setting: electrolyte mixtures, chemotherapeutics, and anesthetics. The FDA reported over 170 instances of shortages in 2010, with an increase projected for this year. President Obama also expressed his support for legislation that would require streamlining the notification process; pharma companies would have to notify the FDA of shortages six months in advance. All of this is good news for patients, who stand to benefit the most from timely intervention in acute medical treatments. | LINK

1. In the past week, Obama has issued orders creating relief for “underwater” homeowners and current college students with high tuition debt.

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New rules for accountability care organizations out today from CMS may please providers amid reports of inefficient care delivery models and quality. When the feds released initial ACO rules earlier this year, the process was met with major rounds of criticism with physicians barking the loudest. As a group, its top concern was the financial risk involved (lowered reimbursements amid higher penalties) in agreeing to participate.

Quality benchmarks in EHR adoption and clinical outcomes in certain key chronic medical diagnoses as part of the ACA-mandated rules have all but been retooled with the release of new ACO parameters.

The regulations reduced the number of quality measures by about half and increased the financial incentives for providers. The changes won preliminary praise from major trade groups and professional associations, which moved quickly to digest hundreds of pages of rules from multiple federal agencies, including the CMS, the Federal Trade Commission and the Justice Department.

Enhanced opportunities in order to improve quality amid a decrease in the perceived risks of doing so. With this new credo in place, many initial hostilities toward the inclusion of ACOs within the scope of reform may be tempered just a bit. | LINK

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