Protracted Investigation of U of M Physician Ends

[This article posted on December 20, 2011. It is posted within the following categories: Corporate, Pharma & Devices, via Michael Douglas, MD, MBA.]

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

[This article is contained within the following tags:

Hospitals Trumpet Pharma Detail Strategies, Enhance Healthcare Sales Strategy

[This article posted on December 14, 2011. It is posted within the following categories: Corporate, Pharma & Devices, via Michael Douglas, MD, MBA.]

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

[This article is contained within the following tags:

Functionally Strangled by Drug Treatment, Minnesota Patient Loses Trust but Gains Empowerment

[This article posted on December 9, 2011. It is posted within the following categories: Corporate, Diversions, via Michael Douglas, MD, MBA.]

When she was diagnosed with multiple sclerosis, a Minnesota woman thought that her carefully chosen neurologist had her best interests in mind when prescribing initial treatments to modify the disease. That was before a little detective work uncovered the real motivation for her physician’s patterns of prescribing that left her even more debilitated than when she was initially showing symptoms.

It worried me that none of them ever suggested that I discontinue treatment—or switch to another treatment—even after I reported that my injection site reactions were affecting my quality of life. Despite the fact that my neurologist insisted that I begin disease-modifying therapy, I was never contacted by him, his nurse, or anyone else in the neurology clinic with questions about how my Copaxone injections were going.

The patient, a U of M philosophy graduate student, puts into her own words the ethical issue she gradually uncovered while under the specialist’s care. Just how influential are pharma companies’ financial compensations for physicians who choose to prescribe their products? Just how willing are they to prescribe knowingly untested medications without concern as to their problematic and potentially lethal adverse effects? Her answer came at her next appointment, after enduring months of increasingly debilitating pain and enfeebling function from the trial with the first drug.

[M]y neurologist informed me that I’d begun to develop lesions inside my brain stem. He explained that this was a very bad place to have lesions, occupied as it is with regulating some of the body’s basic functions, such as breathing. He strongly recommended that I go back on MS treatment, suggesting this time a drug called Tysabri (natalizumab), which had worked wonders for some of his patients but also carried some amount of risk. Worried about the new lesions, but knowing little about the drug he was advising, I told him I’d think about it. I needed to be convinced through my own investigations that this drug would be worth taking.

Her investigations were not only telling, but they are also indicative of an all-to-familiar refrain for patients of (mostly specialist) physicians who pocket major coin from pharma companies to get these ridiculously expensive agents to the marketplace, at the risk of patient harm. In Minnesota, the patient was assisted by a database which lists pharmaceutical third parties with which a prescribing physician has a financial interest. She makes little doubt of her eagerness for this requirement to spread nationally as the result of the reform law. | PDF LINK

CMS (Finally) Makes Claim Data Public

[This article posted on December 7, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

The federal government finally announces that it will open up its Medicare claims database to allow third party access (advocacy groups, insurers, hospitals, etc). This follows a few years of speculation on the part of pundits and legislators alike on what such a move could entail and how it would impact heatlhcare reform — in particular, enhancing quality parameters. The benefits of availability of such information gleaned from billing, requisitions, and payments will vary among groups seeking such data.

Though the data aggregate is invaluable for constructing tools for everything from clinical trials to arranging care delivery based upon demographics, there is always the specter of misrepresentation of that data. For years, many clinicians (including professional associations like the AMA) have lobbied against the release of such info on the gounds that internal reviews should be made before that info is released to the general public. End data may not always be reflected by the healthcare delivery means for many difficult-to-treat patients, for example.

Still, the move is a win for groups wanting to move beyond the formerly impenetrable wall imposed and maintained by physicians and physician groups in order to access that gold mine of clinical, financial, and parametric information. | LINK

Minnesota Makes Public Exchange Prototypes

[This article posted on December 6, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, Knowledge & Medicine, via Michael Douglas, MD, MBA.]

Are the citizens of Minnesota ready to take a look at prototype models for healthcare exchanges? The marketplace stimuli as part of reform are being unveiled today. Although it may seem early for such exposure, MN must demonstrate that it can operate an exchange as part of reform much sooner — just over a year from now, in fact. Four companies have placed demo modules up for public review. Playing around with a couple of them, I get the feel of sites that are actually consumer portals into products that resemble reservation services, only instead of purchasing a flight or hotel accomodations, I am choosing a provider which can treat certain chronic conditions more cheaply, for instance, in one organization in comparison another based upon my personal situation.

States participating in this exercise which are not able to fully integrate these virtual exchanges at the outset of reform will get fed assists. Minnesota seems ahead of the curve here, as the governor has taken a seemingly personal role in getting this state’s offerings public and implementing diligent task-force support to the process early.

[This article is contained within the following tags:

Pfizer’s Game Plan Critiqued

[This article posted on December 4, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

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

[This article is contained within the following tags:

Pharma Company Strives to Keep Star Performing Drug Close

[This article posted on December 1, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

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.

[This article is contained within the following tags:

Minnesota: Healthcare Economist Predicts Positive Access to Care Under Reform

[This article posted on November 19, 2011. It is posted within the following categories: Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Political coalitions here in Minnesota have largely towed the Democratic line, having gone decidedly blue in the last presidential election in spite of reports that the state was a purple one “in play” in an ultimate result that was anything but close.  The building within the democratic base also stands to reap benefits with respect to the reform law by its inception in 2014.

This, according to an MIT healthcare economist.

[Jonathon Gruber] told members of a governor’s task force Thursday that the federal health care law will reduce the health insurance racial disparities in Minnesota. [...] Gruber projects that almost 300,000 additional Minnesota residents would gain insurance coverage by 2016, and that those who currently buy health insurance on the individual market could pay 20 percent less in premiums after taxes.

Gruber was speaking in terms of the savings generated by increased access to healthcare with the advent of exchanges under reform. Dem Governor Mark Dayton has recently formed a couple of healthcare task forces — one of which will exclusively work to develop an exchange to increase access to the state’s un- and under-insured. | LINK

[This article is contained within the following tags:

WH Launches Front-End Program to Expand Healthcare Delivery Ahead of Reform

[This article posted on November 14, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

Grants in the total amount of over $1B will be targeted to healthcare orgs that work with federal agencies in an effort to increase the size of the overall healthcare workforce. The Obama administration is expected to announce today the availability of the funds to get initiatives started in as little as 6 months. I must admit, I was sent information on taking part in this effort.

“This will open the inbox for many innovators and organizations that have an idea to bring to the table,” Don Berwick, administrator for the Centers for Medicare & Medicaid Services, said in an interview. “We’re seeking innovators, organizations and leaders that have an idea to bring into further testing.”

Participating orgs with ideas brought to the table will be  grouped in the specially named CMS Center for Medicare & Medicaid Innovation. The initiative, praised by CMS head Don Berwick, is betting on using federal monies as an incentive to get the government involved in vetting other possible ways to spend more frugally ahead of reform and a pending physician shortage by decade’s end — two scenarios that will have to be met forcefully to ensure the onslaught of much needed healthcare delivery that won’t come cheap. | LINK

It’s Back to Basics in Nursing Homes in Treating Disease

[This article posted on November 8, 2011. It is posted within the following categories: Diversions, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

Just under 13 percent of skilled long term care facilities here in Minnesota are part of a project that is aimed at reducing the “supply side” of potentially unnecessary hospitalizations in the care of their elderly patients. The three year initiative is based upon data already gleaned from smaller tests and it essentially involves going back to the fundamentals of physical diagnosis — from all members of the skilled provider team.

“The problem is the doctors,” [Dr. Robert Kane, a University of Minnesota aging expert who is helping lead the experiment, said.] “Physicians familiar with nursing homes learn quickly to trust the precise information from nurses using the Interact tools. But for the others, especially nights or weekends, the default is hospitalization.”

I like to think of this as a recognition about what physicians have always known about medicine. Nothing substitutes for a thorough physical exam, regardless of who the examiner is. Any effort to utilize the good ol’ noggin to diagnose and treat without the knee-jerk rush to the hospital ED to provide primary care is always preferred, and it saves the proverbial bean counters on the acute care side of things (hospitals) of having to deal with yet another inappropriate admission. | LINK

Indiana Seeks Exemption from Key ACA Provision

[This article posted on October 12, 2011. It is posted within the following categories: Corporate, via Michael Douglas, MD, MBA.]

From the Did You Know category today: the state of Indiana is challenging a key provision of the ACA having to do with the medical loss ratio for insurers. That’s the amount by which insurance premiums are set a certain degree of cost implementation for overhead. The ACA requires the insurer to spend 80 percent on healthcare delivery, or else pay a fine. Indiana is pursuing a federal waiver from this proviso. Healthcare consumer advocacy weighs in.

Indiana’s application is based on state politicians’ ideological opposition to health reform, not the realities of the state’s health care market … As the MLR regulations make clear, there must be a credible threat to the stability of the individual marketplace in order to grant a waiver. Indiana has demonstrated no such threat. We urge [HHS] to reject Indiana’s application.

Indiana is the only state in the country to request that consumer high deductible health plans be exempted from MLR provisions unconditionally. HHS will ultimately decide on the matter. | LINK

[This article is contained within the following tags:

Republicans Avoid Criticizing Own Costly Medicare Legislation

[This article posted on September 21, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

On the campaign trail recently, top GOP candidates have been rolling out the talking points with respect to the debate on healthcare policy and politics. That latter point is made quite clearly in the party’s stance on the “solvency”[1] of the prescription drug benefit under Medicare Part D. Asked whether this rather costly program — arguably one of the most significantly costly from the George W. Bush administration’s passage of MMA in 2003 — should be yanked (as they feel so-called Obamacare should be), you’ll get a resounding “no” on that policy point.

Although the House GOP have led the deficit hawk brigade in response to President Obama’s recent comments on balancing the budget, the party as a whole has been relatively quiet on the Medicare overhaul issue, especially as it pertains to Part D — a program the party structured and passed under Bush eight years ago. It’s no secret politics is in play, especially when monies to support the benefit have to come from the government’s general coffers — competing for earmarks for other priorities, like education funding.

Republicans like to point out that throwing drug coverage under Medicare, in part, to the pharma marketplace has offset initial costs for supporting the program via competition. But, currently, the wide variety (amid the spate of new branded preps) of traditionally cheaper generics probably has to do more with keeping costs low — with respect to beneficiary affordability and the marginal profits on such non-branded offerings by Pharma.

Fast forward to 2011 and the popular Medicare provision is being utilized by over 60 percent of retirees (with the balance coming from former employers’ plans), and it looks safe for now. The big unknown is when the inevitable resurgence in pharma spending increases will occur over the next ten to fifteen years — and how Part D will fare within the reform mix. | LINK

 

  1. There really is no dedicated tax toward funding the Medicare prescription drug benefit. []
[This article is contained within the following tags:

Report Examines Progress of States in Insurance Exchange Formation Ahead of Reform

[This article posted on September 12, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Ever wonder how the preparations for healthcare exchanges are proceeding? The Kaiser foundation has constructed a brief [PDF] which allows one to reasearch states’ plans in progress. To review, the establishment of healthcare exchanges by the feds under reform is meant to enable consumers to compare a selection of qualified health insurance options in order to find the plan that best meets their needs and budget — with a significant amount in taxpayer subsidies devoted to this purpose.

Among the highlights in the brief report: (1) discussion of governance of exchanges, with some states granting significant control over governance matters at the hands of the excutive branch; (2) plans by states to address conflict-of-interest issues regarding insurance plan representation within governing boards of exchanges; (3) the total amounts paid to states so far in the funding of exchange formations in their individual healthcare marketplaces; and (4) the effect of legal challenges brought forth in some states regarding the constitutionality of the insurance mandate provision of the ACA (most recently, the striking down of the state of Virginia’s challenge filed by its atty. gen.) on the formation of exchanges.

[This article is contained within the following tags: