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

PSA Screening Guidelines Offer Discussion and Learning Opportunities

[This article posted on October 27, 2011. It is posted within the following categories: Diversions, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

One axiom is certain in medicine: there is always room for controversy. And that’s good, because it spurs further scholarly thought and research — both qualities can only help patients and providers in the long run. With the current discussion in the media regarding the utilization of the PSA in determining the course of action in prostate cancer screening, so many fundamental issues surrounding patient informed consent, unnecessary treatments, and the potential harms from treatments — can serve as valuable teaching points for patients and current and future physicians alike. The discussion — highlighted in the current NEJM — really brings this point home.

Watchful waiting and active surveillance may help prevent the conversion of overdiagnosis to overtreatment, mitigating the harms of screening that are so accurately portrayed by the task force. … we primary care clinicians must ensure there is no more routine, indiscriminate PSA screening — and no washing our hands of responsibility once the patient is referred to a specialist for prostate-cancer treatment. We owe it to our patients to provide them with the kind of guidance about this screening test that they need and deserve…

LINK | USPSTF guidelines on PSA screening here

Study: Many Medicare Beneficiaries Obtain Surgeries in Last Year of Life

[This article posted on October 9, 2011. It is posted within the following categories: CMS, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

A new study out of Harvard finds that approximately a third of all Medicare beneficiaries in the last year of life chose to have a major surgical procedure. The operative (excuse the pun) issue here is whether such timed, elective surgeries are necessary — implying a possible increase in life expectancy. Problem is, no one knows when the beneficiary will die.

By analyzing Medicare claims data the study authors found that, in a group of almost 2 million elderly beneficiaries, all of whom died in 2008, almost one-third had inpatient surgery in the year before they died, almost one in five in the last month of their lives and almost one in 10 in the week before they took their last breath.

The study itself is a good lesson in who exactly “benefits” in these cases. As futile as these findings may sound, there is no question that any procedure done within FFS Medicare coverage remains a reimbursement cache for the provider and hospital, crudely suggesting a financial incentive. While this scenario is entirely possible, it really doesn’t seem to be the impetus for the study’s findings, in my humble opinion. Besides being reflective of a cynical and laconic way of approaching the study’s results, it really makes no sense in a healthcare delivery system increasingly focused on positive outcomes (read: anything but mortality or unacceptable morbidity). The study, however, does usher in the need to discuss the perennial issue of quality of life versus the “appropriateness” of acute surgical treatment among consenting patients with significant chronic illness.

Social Media Research Involving Dementia Revving Up (in Norway)

[This article posted on September 20, 2011. It is posted within the following categories: Diversions, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

Sign of the times: social media’s use in increasing interaction among patients with dementia. A researcher, part of a team, is busy at work on a web-based app based upon Facebook for utilization among cognitively impaired elders. She states:

“We have already carried out some practical testing of other web-based communications systems. Among other things, we have tested a “digital diary” and a “scrapbook” containing personal photos, newspaper cuttings and information found online.”

What is both curious and puzzling at the same time regarding this research is that it is being conducted in Norway, of all places. Why not here in the good ol’ U.S. of A? Innovation of this type began and germinated here. Social media’s global function of “keeping one in the loop”, including the elderly, can not be understated in its potential in non-pharmacologic dementia research. Here’s to hoping it gains ground on these shores.

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Multi-Faceted Effort to Increase Alzheimer Disease Awareness Launches

[This article posted on September 13, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Alzheimer dementia continues to be among the most heavily researched and funded chronic diseases in medical science today. The increased awareness, brought into the spotlight and “modernized” more than 20 years ago following the high profile revelations of celebrites and politicians afflicted with the disorder, has led to increased patient education, public policy initiatives, and, of course, greater research monies in the effort to not only treat symptoms, but also to find a cure.

An international advocacy group is now asking municipalities to take awareness a notch higher with the commitment to even greater awareness of the disorder — addressing what it calls a “treatment gap”, hampering any gains on detection of the disorder at its earlier stages. Here in the U.S., the Obama admin is apparently hard at work in developing the country’s first-ever national anti-Alzheimer strategy aimed at sharply cutting the enormous healthcare costs associated with ancillary treatment .

The National Alzheimer’s Project: From Act to Action is an effort to support a committed and effective implementation of the National Alzheimer’s Project Act (NAPA). Information collected from individuals living with the disease, caregivers, providers and other stakeholders will be shared with the U.S. Department of Health and Human Services, which is responsible for creating a national strategy to address the crisis and coordinate across government agencies. This project is facilitated and supported by the Alzheimer’s Association.

Consider this effort an amalgam of citizen awareness and discussion (townhalls) and legislation (congressional passage of the National Alzheimer Project Act) garnering bipartisan[1] support to fight a scourge that can leave heavy financial tolls on caregivers, families, and the healthcare delivery system itself.[2] A daunting task, to be sure — but one that is sorely needed. Here’s looking forward to December — the date when the president makes his plans for these initiatives very public. | LINK

  1. Just how bipartisan? In 2007, Newt Gingrich co-authored an article in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association, making the case for the creation of a federal Alzheimer strategy. []
  2. Alzheimer’s Association advocates sent more than 15,000 email messages to the White House asking the President to sign the National Alzheimer’s Project Act into law; on 1/4/11, he did — making this action the most significant legislative action with respect to Alzheimer funding intiatives up to this point. []

Walter Reed Hospital Closes

[This article posted on August 29, 2011. It is posted within the following categories: Healthcare Policy & The Media, Knowledge & Medicine, via Michael Douglas, MD, MBA.]

After more than a century of service (102 years, to be exact), Walter Reed Hospital in DC is closing its doors. This seemed to be an inevitability, especially after the facility had a difficult time separating itself from its healthcare delivery scandals during the George W Bush administration.

The Walter Reed Army Medical Center in Washington, D.C., closed its doors for the final time Aug. 27 as the remaining 18 patients were moved to the National Naval Medical Center in Bethesda, Md., one day ahead of schedule, thanks to the approach of Hurricane Irene. Walter Reed had provided medical care to military service members for 102 years.

While the beacon of military medicine is shutting its doors, the Reed moniker will still be intact, as those final 18 patients are transferred to the Bethesda National Military Medical Center — which will now be known as the Walter Reed National Military Center. | LINK

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Primary Care of HIV Patients Increasing in Importance

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

Much has been written of late regarding the initial media presentations of the virus that causes AIDS and the de rigueur comparisons to how far awareness, activism, and innovation have propelled its discussion to every corner of the planet in 2011. Its chilling descriptions more than thirty years ago cannot belie the fact that, in spite of advances, there is still much to be done on the road to eradication and cure. Within this paradigm is the notion that an entire generation or two have witnessed how the existence of HIV/AIDS has shaped healthcare policy in this country and worldwide.

Here in the U.S., the specter of the aging patient with this now “manageable chronic disease”, the numbers of patients this will represent, and the availability of physicians knowledgeable enough to not only treat chronic HIV disease but also its unknown effects in the increasingly “geriatric” patient — are gaining consideration and acknowledgement in policy circles. Discussion almost always leads to the role of the primary care physician in not only screening but also becoming an active treatment provider.

In 2009, a record 82.9 million American adults were tested for HIV. [...] By 2015, the IOM estimates that half of Americans living with HIV/AIDS will be older than 50. For primary care doctors, this means a growing number of their patients will need care for chronic diseases as well as HIV.

Today’s generation of physicians has inhereted the mantle of providing care for a disease whose spurred innovations ranks as one of the greatest medical achievements of the last century. It is time to consider the primary care approach to chronic HIV disease as another fundamental skill set as reform redefines healthcare delivery in the 21st century. | LINK

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HHS Empowers Patients to ‘Share the Health’ as Part of Reform Messaging Effort

[This article posted on June 22, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Getting the word out about all the preventive services available to Medicare beneficiaries is about as easy as wiping out fraud within CMS completely. But that’s not stopping HHS from pulling out all the stops in an effort to curtail future spending on preventable medical problems.

On Monday, HHS Secretary Kathleen Sebelius announced that the agency was launching a publicity campaign, known as “Share the News, Share the Health” to alert Medicare patients, their doctors and their relatives that the services are available at no charge. “Our job is to make sure every single Medicare beneficiary in the country knows,” Sebelius said.

Chalk it up to a (political) campaign by the federal government to get patients knowledgeable and accepting of the benefits afforded them under the reform law. Overall, this effort is a good thing. At its most superficial, it is a way to catch disease earlier, implement higher quality care delivery for less ill patients sooner, and it represents a time saver for the primary care physician, freeing him from informing the beneficiary in order to make the most of the covered physician service/visit. More profound, however, is the stark effect this initiative could have on patient empowerment — as only slightly more than 10 percent of beneficiaries takes advantage of at least one of the covered preventive medical screenings and services.

HHS Issues Critical Medicaid Policy Guidance for LGBT Beneficiaries

[This article posted on June 10, 2011. It is posted within the following categories: CMS, Politics & The Law, via Michael Douglas, MD, MBA.]

President Obama has issued policy guidance on the extension of healthcare benefits under Medicaid for gay couples.

Under the new guidance, dated June 10, states have the option to allow healthy partners in a same-sex relationship to keep their homes while their partners are receiving support for long-term care under Medicaid, such as care in a nursing home.

This is significant, because, as the article states, states have the ability to seize property to pay for overdue medical charges once a beneficiary’s ability to pay is exhausted. The presence of a spouse in a married relationship living on that property would prevent liens and seizures from taking place, allowing Medicaid benefits to kick in. The same-sex partner living in the home would abort any power the state would have in realizing payments under those alternative conditions for beneficiaries receiving long term care services.

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Key ACA Provision Regarding Medicare Spending Oversight Finds Many Foes

[This article posted on April 25, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

Recent concerns of two members of congress have upped the ante in the war against a key provision of the ACA: the development of an independent payment advisory board[1] for the purpose of overseeing payments made by Medicare in the event of rapid spending growth in the healthcare delivery sector. It’s just the latest argument in the ongoing saga to balance the major deficit facing the federal government in the wake of world crises, skyrocketing fuel prices, and the controversial Ryan plan.

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  1. Under the PPACA provision, the board cannot make recommendations to ration healthcare delivery, raise revenues or increase beneficiaries’ premiums, deductibles or co-payments. Recommendations of the board will become law unless the House and the Senate each adopt, by a 3/5 majority, a resolution to block them. []

Congresswoman’s Staff Renews Call for Funding of Care for Complex Head Injuries

[This article posted on April 22, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Politics & The Law, via Michael Douglas, MD, MBA.]

Sometimes it only takes a troubling incident — which is then propelled front and center into the nation’s consciousness — to formulate advocacy. AZ congresswoman Gabrielle Giffords’s close call with death at the hands of a mentally ill individual is about as high profile a case as an advocate for change can seize to create awareness.

It’s no surprise, then, that key members of her staff are raising the awareness level of care surrounding traumatic brain injury, or TBI. While this is not a new issue by any means — it has usually been relegated to also-ran status in the eyes of healthcare policy watchers and lawmakers alike, as a by-product of the cost of care to the problem’s biggest cohort, the military veteran — it is getting a new lease on life.

[A] “central component” of Giffords’ therapy regimen is cognitive rehabilitation therapy, a costly medical treatment designed to retrain the brain to do basic tasks. Such treatment … may be available to Giffords, but it is out of reach for thousands of U.S. troops whose health coverage doesn’t include it. The Pentagon’s health care program, Tricare, has refused to cover it but does cover certain types of therapy — such as speech and occupational therapy — which can be a part of cognitive rehabilitation therapy.

HHS Secretary Sebelius is the initial target of this newfound campaign brought by Giffords’s staffers, as they seek to expand such offerings under the military’s Tricare plan. It’ll be a steep hill to climb; such coverage can average $8000 – $10000 for acute hospital cares/day, and at least $1500 daily in LTC costs outside of that acute care. Adovcates, acknowledging this, will also press current Sec’y of Defense Gates to expand coverage for such services. Good thing Giffords’s office also clarifies that this advocacy is a “first step” as far as cost of delivery is concerned — noting that the range of coverage for comprehensive TBI acute care and rehab would not extend the range of “essential benefits” for servicemembers under Tricare. | LINK

Report: Branded Drug Use Sharply Down, Generics Way Up

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

A healthcare informatics company issues a report today that I really do not find surprising. The trends of Pharma of late are much fewer fast-tracked medications in the pipeline, decreased NDAs for many novel and like-classed (so-called “me-too” drugs) medications, and — are you ready for this? — much greater healthcare consumer spending on generics, which, according to the report, now make up almost 80 percent of the pharma marketplace.

It would be too easy to blame this on the economy. At the root of this and other findings detailed in the report are forces more complex in the healthcare economy than just the principles of supply and demand. After all, while there are fewer patient visits and greater demand by providers and health systems for payments by third parties, you can bet that Pharma still manages to turn a profit. Just take a look at the volume of sales by therapeutic areas: anti-cancer drugs continue to lead the way.

The top five therapy classes were: oncologics, with $22.3 billion in 2010 spending; respiratory agents, at $19.3 billion; lipid regulators, at $18.7 billion; antidiabetes drugs, at $16.9 billion; and antipsychotics, at $16.1 billion. Growth in spending among these classes ranged from 0.9 percent for lipid regulators to 12.5 percent for antidiabetes medications.

Although consumers, third party payers, hospitals, and providers all appear to be embracing quality provisions as a way to control costs, it is somewhat less clear what this pharmacologic austerity will ultimately mean for the management of chronic disease and how that will impact the cost of healthcare over the next 10 years. | LINK [PDF] to IMS report

Initial Effects of a Government Shutdown on Medicare, Medicaid Minimal

[This article posted on April 8, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

As the possibility of a government shutdown grows greater by the hour, news media all over the country are offering accounts of what exactly the effects of a federal government stoppage would entail for the economy and the nation. In the case of 1996, it’s essentially déjà vu all over again; the conflict that pitted then-President Bill Clinton against the Contract with America architect and House Speaker Newt Gingrich was essentially a showdown over Medicare spending and public healthcare delivery.

[UPDATE: Government shutdown averted as Dems and GOP strike literal 11th hour deal.]

Fast forward fifteen years and President Obama, Sen. Maj. Leader Reid, and House Speaker Boehner are at a similar ideological stalemate. Although the principal pursuits which led to this moment deal with the budget deficit as an overarching factor, the cost of Medicare and Medicaid to taxpayers is certainly part of the mix. According to the OMB, beneficiaries of these entitlements should be okay, at least in the short term. Officials with the budget agency say that both Medicare and Medicaid are not funded via annual appropriations, and as such, would not be affected in the manner of other programs that do have an annual funding source.

Patients will still receive care. Payments will still be made to providers, hospitals, and other care entities which submit bills for services rendered. If the budget impasse resulted in a protracted government shutdown, the outlook is a little murkier. Salaries for workers within CMS and for those who work in private insurance company settings (that process Medicare claims, for example) are appropriated yearly — and would definitely be affected with payment delays followed by back pay allowances once things get back on track.