Whistleblower Lawsuit Prompts Fed Action on Alleged Medicare Long Term Care Fraud

[This article posted on January 5, 2012. It is posted within the following categories: CMS, Corporate, via Michael Douglas, MD, MBA.]

The long term care marketplace is one of those sectors in healthcare delivery on the cusp of markedly innovative practices in this young century, buoyed by the sudden proliferation of the senior Boomer demographic. Sky’s the limit on the impact of care services and offerings a market-based approach can muster on the eve of reform. Unfortunately, certain models are ripe for abuse.

The DOJ said today it joined a whistleblower case against AseraCare in federal court in Birmingham, Alabama, accusing the closely held company of seeking to cheat Medicare for the hospice care of patients who weren’t terminally ill. The U.S. is seeking three times the damages and a penalty of $5,500 to $11,000 per claim.

The hospice company is owned by a national company that provides services within LTC. Whistleblowers prompted the government action when the hospice operation recruited Medicare beneficiaries and continued to fraudulently collect payments by inappropriately cycling those patients under the hospice benefit. The process would continue upon initial termination of Medicare payments for those services once the initial LTC services ceased. Multiple referrals for covered services later, the LTC contractor would continue to collect those payments, based upon allegedly fraudulent qualifying practices by the LTC contractor/company.

The case is an interesting one which will, hopefully, provide Medicare reform in yet another overlooked care sector that will only increase in prevalence as the rate of patients diagnosed with chronic disease and disability skyrockets. More here

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Editorial: Innovation without Diligence Negatively Impacts Healthcare Access

[This article posted on January 3, 2012. It is posted within the following categories: Corporate, Knowledge & Medicine, Pharma & Devices, Science & Research, via Michael Douglas, MD, MBA.]

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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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

House GOP Actions Force Senate Showdown on Payroll Tax Cut Extension, Medicare ‘Doc-Fix’

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

Honestly, these “clock-ticking countdowns” are getting a little irksome. The eleventh hour negotiations surrounding the legislative extensions of the payroll tax cuts for the middle class just hit another roadblock, outlets have reported. Cue the Senate showdown between the GOP and Dems. Closely tied into the GOP plan for the extension of the tax cut is the inclusion of the Keystone XL oil pipeline — a controversial project which President Obama had originally hoped to decide upon by 2013 its potential for environmental sustainability.

The Keystone pipeline pawn would force Obama to make a decision on its contruction by the end of this year.

With respect to healthcare, the inclusion of provisions to forestall cuts to Medicare payments for 2 years, preventing incremental threats to physician reimbursements (no permanent overhaul), would be the political gambit. It’s a political mixed bag for some healthcare entities. Hospitals would be better served by more long-term solutions to the so-called doc-fix problem. Providers would be spared more frequently intermittent threats to reimbursement. If passed, this payroll tax cut extension would eliminate the possibility of approximately 27 percent in cuts to Medicare payments.  | 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

Berwick Offers Criticisms on Eve of Departure

[This article posted on December 5, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

He’s leaving his much embattled post, and he is not mincing words. Don Berwick will be stepping down as CMS head in lieu of what was sure to be a highly contentious Senate confirmation procedure next year. Calling much of what Medicare “does” as wasteful, the departing CMS chief sounded more like he was delivering a eulogy than offering up hopeful solutions to be implemented in his absence.

Dr. Donald M. Berwick, listed five reasons for what he described as the “extremely high level of waste.” They are overtreatment of patients, the failure to coordinate care, the administrative complexity of the health care system, burdensome rules and fraud. “Much is done that does not help patients at all,” Berwick said, “and many physicians know it.”

Berwick’s ascension came at a time in which President Obama was looking for a CMS chief who shared the same sense of analytical urgency in efforts to fix the nation’s ailing healthcare delivery system. Berwick sounded the clarion call for reform, but received very little cooperation from the GOP side of the ideological aisle, with those members of congress (and some Dems) essentially putting up a wall between him and any actionable improvements. Perhaps his own words project why he was essentially doomed from the start.

Berwick said he had not sought the job. Indeed, he said, “I did not even know if I was fit for it.” He took the post, he said, because he sensed that immense “tectonic shifts” were occurring in the health care delivery system.“I came with an agenda,” Berwick said. “I wanted to try to change the agency to be a force for improvement, covering one out of three Americans.”

Restating the obvious really does physicians he laments no good unless positive change, outside of obvious hyperbole, does occur. According to many pundits — including this one — his replacement offers more of the same, with true change occuring only if legislative control swings back to the Dems in 2012. | LINK

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Medicare Now Provides Coverage for Obesity Treatment and Prevention

[This article posted on December 2, 2011. It is posted within the following categories: CMS, Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Medicare will now expand its breadth of covered preventive services to include obesity treatment and management. In what could be a sign of the increasing population of beneficiaries who were weaned in the Boomer mentality, treatment coverage for such a hot-button topic among politicians, lobbyists, healthcare advocates, and physicians themselves — will remain, indeed, controversial. According to CMS, obese Medicare beneficiaries (defined as those with a body mass index of 30 or higher) may see their primary care physician for one face-to-face visit every week for the first month. Then, Medicare will pay for one face-to-face visit every other week for the next five months. If the patient loses at least 3 kg (6.6 lbs.) over the first six months, Medicare will pay for an additional six months of once-a-month face-to-face visits with the doctor.

Insurance remains above the fray here. While the feds may explain away this coverage as putting a dent in future healthcare costs associated with the obese patient, the fact remains, that outside of a universally defined pragmatic treatment regimen (ie, dedicated drugs = dedicated reimbursements/payments) — provider acceptance of this latest move by CMS will continue to advance at a trickle. It’s hard to get on board with yet another taxpayer funded government initiative whose intentions really haven’t been proven to lower across-the-board healthcare costs, lower all-cause mortality, and assume that all physicians are competent weight-loss counselors. Also: about 30 percent of beneficiaries are projected to qualify for this latest Medicare preventive care benefit. | LINK

AAMC: Medical College Admissions Testing to Be Overhauled

[This article posted on November 26, 2011. It is posted within the following categories: Diversions, Knowledge & Medicine, via Michael Douglas, MD, MBA.]

The year was 1989. Late summer. The pressure was on to perform. Whether it was due to studying inertia, laziness, or simply hubris — I elected to take the dreaded MCAT (the medical college admissions test) at the latest possible offering. Yes, I was reasonably confident of my standardized test-taking abilities, and I knew that my GPA could definitely hold its own. Still, as I look back on my senior year in college, delaying such an important and redoubtable requirement was pretty foolhardy.

Nineteen eighty-nine was also approximately the period in which the test gurus who formulated the exam took a curious turn and seemed to bend over backwards answering critics’ and educators’ assertions that the exam was too narrowly focused on the left-brain aspect of scholarship. What was needed, the sage designers of the MCAT decided, was a tool to measure the non-scientific literacy of those who were audacious enough to consider a career in medicine. Thus, the maligned essay question was introduced.

The body tasked with reviewing the MCAT’s current state of affairs has made its concerns with the exam’s future known, and it reflects a growing reality in the state of preparing those with an interest in medicine to be able to succeed in medical school. That medicine is constantly changing with respect to rapid advances in basic science research and social and economic healthcare policy trends is a complete understatement, one that is highlighted by the committee’s recommendations.

The new MCAT will preserve the best features of the previous exam, while ineffective sections (e.g.,the writing sample) will be jettisoned. The two natural science sections will be revised to focus on relevance to living systems, emphasis on critical analysis, and reasoning skills will increase in a revised verbal section; and a section on behavioral and social sciences will be added.

Yes, it has taken the testing gods some twenty years to kill the essay section. Well, here’s hoping that future practitioners of medicine will have the intestinal fortitude that successive iterations of the MCAT (starting in 2015) will now require — the quality of endurance. As it stands, testing length will increase by over 40 percent — to 6 hrs and 15 min. Ouch! Guess I’m glad my laziness didn’t get the best of me some 22 years ago! | LINK [PDF]

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Study: Paucity of Drugs Responsible for Nearly 100K Acute Hospitalizations in Elderly

[This article posted on November 26, 2011. It is posted within the following categories: Pharma & Devices, via Michael Douglas, MD, MBA.]

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

Pharma Company to Pay Over $900M from Vioxx Marketing Practices

[This article posted on November 22, 2011. It is posted within the following categories: Corporate, Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

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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Appeals Court Upholds Constitutionality of ACA

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

News comes today from a largely conservative appeals court, no less. (Does the ruling in support of the law by a solid conservative justice on the appeals panel nix the idea that ideology is controlling the judges’ votes on this very politically-charged and polarizing issue?)

The Obama administration prevailed Wednesday in the first appellate review of the 2010 health care law as a three-judge panel from the United States Court of Appeals for the Sixth Circuit held that it was constitutional for Congress to require that Americans buy health insurance.

All of this — as the SCOTUS prepares to consider this week whether to resolve conflicting rulings over the law’s requirement that all Americans buy health care insurance.

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States Continue to Deal with Medicaid Spending Post-Stimulus and Pre-Reform

[This article posted on November 2, 2011. It is posted within the following categories: CMS, via Michael Douglas, MD, MBA.]

Okay, here’s what we do know about the current state of solvency of Medicaid post-stimulus funding: states are grappling with a larger share of Medicaid liabilities than before, and they are immediately reacting with a combination of cuts to providers/hospitals and pulling in the reins on certain services.

Although states are bearing a bigger share of the Medicaid burden this year than they have in the recent past, overall Medicaid spending (state and federal dollars) is projected to grow by only 2.2 percent, the lowest amount since 2006, [a] Kaiser report [shows]. That is because the stimulus funding ended, and program costs are stabilizing as the national economy shows tentative signs of recovery and enrollment growth slows.

The article is a lengthy one, but worth a read. The Kaiser-funded survey trial of states with respect to this question suggests many states are implementing myriad Medicaid spending stopgaps in the short term. All this is on the table as the bipartisan so-called congressional supercommittee gets ready to release its report on trimming the current budgetary deficit.

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Obama to Sign Executive Order Addressing Shortages of Medicines

[This article posted on October 31, 2011. It is posted within the following categories: Corporate, Pharma & Devices, via Michael Douglas, MD, MBA.]

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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