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Thursday
Jun062013

A very special issue of Medical Acupuncture

Every so often, our “friends” on the other side of the science aisle (i.e., the supporters of “complementary and alternative medicine”—otherwise known as CAM or “integrative medicine”) give me a present when I’m looking for a topic for my weekly bit of brain droppings about medicine, science, and/or why CAM is neither. It’s also been a while since I’ve written about this particular subject; so it’s a win-win for all sides! I get a topic. A certain CAM journal gets extra traffic. And you get the benefit of my usually brilliant deconstruction of dubious science. What could go wrong? I mean, I might not be Mark Crislip, but I do enjoy a good dive into a pile of pseudoscience every now and then. It’s just a weird trait of mine.

In any case, there is a journal called Medical Acupuncture. Sadly, it’s published by a real scientific publisher, Mary Ann Liebert, Inc., a publisher that has a stable of decent, if not top tier, journals. Unfortunately, it also has a stable of CAM journals, including, of course, the aforementioned journal Medical Acupuncture. Because I happen to be on the mailing list for Mary Ann Liebert, Inc., I recently got an e-mail with an announcement:

How Does Acupuncture Work?
The Science behind the Therapy Is Explored in a Special Issue of Medical Acupuncture

New Rochelle, NY, April 16, 2013—Even as medical acupuncture is increasingly being validated as an effective treatment for a broad range of medical conditions, what has been missing is an understanding of the basic science and mechanisms of action of this age-old method of healing. A special issue of Medical Acupuncture, a peer-reviewed journal published by Mary Ann Liebert, Inc., publishers presents a series of articles by authors from around the world who provide diverse and insightful perspectives on the science and physiologic responses underlying medical acupuncture. The issue is available free on the Medical Acupuncture website.

“Understanding acupuncture in the same manner that we understand the mechanism of action and pharmacokinetics of a particular drug will, similarly, enable us to match treatments better with conditions,” states Guest Editor Richard F. Hobbs, III, MD. “The net effect will be improved outcomes,” he writes in his editorial “Basic Science Matters.”


The beauty of this gift to me is that not only can I write about the contents of this issue, but the articles are available for free; so you can read them too. No paywalls! One wonders what possessed the editors of this particular journal to provide such an awesome gift to both me and you, our readers.

In any case, I would certainly agree that basic science matters. After all, that’s the whole point of science-based medicine (SBM), isn’t it? That evidence-based medicine (EBM) in its current incarnation relegates basic science considerations to the lowest rung of evidence on its hierarchy of clinical evidence. Indeed, I spent quite some time talking about just that in my talk to the National Capital Area Skeptics a month and a half ago. Basically, EBM suffers from what I like to refer to as “methodolatry,” which an epidemiologist fellow blogger defined as the “profane worship of the randomized clinical trial as the only valid method of investigation. Indeed, the gods of EBM, namely the reviewers for the Cochrane Collaborative, are particularly prone to methodolatry. Indeed, one of the key points we at SBM try to make is that this sort of methodolatry provides and opening for pseudoscientific treatment modalities like acupuncture to gain the appearance of efficacy in some parts of the medical literature. Basic science considerations are, in essence, ignored in determining whether there is sufficient prior scientific plausibility of acupuncture to treat, for instance, infertility or depression, and equivocal, bias-prone clinical trials are ranked much higher than the basic science considerations that make the hypothesis that acupuncture can do anything for infertility so implausible as to border on impossible, barring new evidence speaking to its plausibility.

Of course, in a way acupuncture is a special case. I’ve said it before, and I’ll say it again (at the risk of boring my readers): I actually used to think that maybe there was something to acupuncture, for the simple reason that it involves an actual physical act on the human body, namely sticking needles into it. On a strictly conceptual level, one can speculate that maybe sticking needles into the skin does something. However, the more I read about acupuncture, the more I delved into the actual scientific literature purporting to support acupuncture, the more I realized that there’s no “there” there, even from studies done by advocates, in which negative or equivocal results are almost uniformly spun to be supportive of acupuncture, and mechanisms that probably have little to do with any purported effects of acupuncture. The “adenosine” mechanism I wrote about three years ago comes to mind. The bottom line when it comes to acupuncture is that it’s almost certainly all placebo. It doesn’t matter where you stick the needles. In other words, acupuncture “meridians” are nonsense, which is not surprising, given that attempts to associate any real anatomical structures to meridians have uniformly failed. It doesn’t even matter if the needles are stuck in; twirling toothpicks against the skin does just as well, dubious systematic reviews of acupuncture not withstanding.

So let’s see what Dr. Hobbes, who is based at Plum Blossom Acupuncture and Integrative Medicine, a clinic that offers woo ranging from acupuncture to cupping to moxibustion has to say about how “basic science matters“:

Medical acupuncture is a part of medicine and is being validated, increasingly, as an effective treatment for a wide range of conditions.1 However, for the most part, we are missing the foundation, the basic science piece. This is a deficiency which, in my view, we must correct. Understanding acupuncture in the same manner that we understand the mechanism of action and pharmacokinetics of a particular drug will, similarly, enable us to match treatments better with conditions. The net effect will be improved outcomes.

How does one define “basic science” in the field of acupuncture? There are traditional paradigms that many of us use every day in treating patients, and then there are views that are informed by those subjects we studied in medical school. So far, efforts to “connect the dots” have not been completely successful. However, progress is being made, and once that goal is achieved, the sharp lines of demarcation between Western and Oriental medicine will disappear.

For this special issue, we encouraged the submission of exemplary studies or comprehensive review articles dealing with research methodologies, physical properties of points and channels, signaling mechanisms, and mechanisms of acupuncture effects.

Apparently, Dr. Hobbes has a different definition of what constitutes “exemplary studies” or “comprehensive review articles” than I do. For instance, the article he cites to support his claim that acupuncture is being increasingly “validated as an effective treatment” for a wide range of (I note, unrelated) conditions is Vickers et al, a systematic review that has been a chew toy of various SBM bloggers, including Steve NovellaMark Crislip, and myself. Basically, Vickers et al was an article that found a “statistically significant” but clearly clinically insignificant difference between pain scores in sham control versus acupuncture-treated patients with chronic pain syndromes, as I discussed in inordinate detail. If this is “clinical validation,” then we should cease all acupuncture studies right now as a pointless waste of money that unethically subject patients to risk with no likelihood of benefit! Amusingly, just a month and a half ago, Andrew J. Vickers, the first author of the review, published a followup rebuttal in (of course!) a CAM journal in which he whined about how those nasty, nasty “skeptics” (he even used the term “sceptics movement” in full U.K. spelling) were so unfair in their criticisms, singling out Steve Novella, a blogger who also wrote about the study under the ‘nym askeptic, and my alter-ego for particular opprobrium.

But let’s look at the rest of what Dr. Hobbes wrote. Truly, it could very well have qualified for Kimball Atwood’s much missed feature, the Weekly Waluation of the Weasel Words of Woo. I particularly like the part where he contrasts the “traditional paradigms that many of us use every day in treating patients” versus the “views that are informed by those subjects we studied in medical school.” Notice how he refers to his beliefs about “acupuncture” as “paradigms” and what he was taught in medical school about the science that says that acupuncture is pseudoscience as “views.” It’s a simultaneously subtle (if you’re not familiar with CAM weasel words) and not-so-subtle (if you are) denigration of scientific medicine. I also like how he uses what I consider to be the racist distinction between “Western” medicine (i.e., evidence- and science-based medicine) and “Oriental” medicine (i.e., traditional Chinese medicine). Seriously, does he even realize the implication he’s making, namely that “Western” medicine is scientific and “Oriental medicine” is touchy-feeling and “holistic”? Doesn’t he realize that there are some damned good “Oriental scientists,” every bit on par with “Western” scientists, and that they have come to the same conclusion, namely that acupuncture is placebo?

So let’s take a look at some of these studies and review articles. The first one that caught my eye was one by John Longhurst, MD, PhD of the Samueli Center for Integrative Medicine at the University of California, Irvine, entitled Acupuncture’s Cardiovascular Actions: A Mechanistic Perspective. Dr. Longhurst begins:

The practice of acupuncture began 2000–3000 years ago. Until the last 50 years, acupuncture developed empirically and its art was passed on from teacher to student through practical application. More recently, practitioners began to find that acupuncture had a rightful place in mainstream medicine and could be used to treat a number of conditions and symptoms. The public outside the Orient has accepted acupuncture because of a perception that it reduces pain effectively and successfully reverses a number of other medical problems. Western medical and scientific communities have been more reluctant to accept this practice because of the absence of controlled clinical trials and scant scientific evidence for its mechanisms of action. However, there may be reason for this skepticism to change. The number of articles published on acupuncture research (451 articles worldwide in 2009) has been increasing almost exponentially over the last several decades, with the United States and China both taking lead roles in advancing understanding of this ancient therapy.1

Don’t you just love the argumentum ad populum (appeal to popularity)? The point is that, because there are now lots of articles on acupuncture and the number has been increasing, it must mean there is something to acupuncture. Never mind that the vast majority of articles are of low quality and that the higher the quality of the research the more likely the findings are to be negative, just like homeopathy.

One thing I noticed about this review article right away is that nearly all the studies it discussed were about electroacupuncture (EA). This is, in my mind, a classic “bait and switch,” in which therapy is described as acupuncture but is in reality nothing more than electrical nerve stimulation clumsily grafted onto acupuncture. One might reasonably expect that electrical stimulation of certain nerves might have physiological effects. For instance, anyone who’s ever undergone a nerve conduction study, as I have, know this. (It’s a study that could easily be used as torture, let me tell you.) The very basis of nerve conduction is electrochemical, and it can be influenced by electrical currents. That doesn’t make it acupuncture. Worse, the insistence of using acupuncture points, instead of nerves that might actually have physiological relevance, only muddies the waters, making it less likely that an actual, useful therapy might be derived from the mix of electricity and the vitalism of traditional Chinese medicine that is “electroacupuncture.” Basically, it’s nothing more than a “rebranding” of acupuncture, which doesn’t work, by disguising something that might work (electrical nerve stimulation) as somehow being acupuncture. After all, the Chinese of hundreds (or thousands) of years ago who supposedly invented acupuncture did not have knowledge of electricity, nor did they have the technology to construct batteries or generators. Personally, I think that it’s telling that in many places I saw references to “acupuncture,” but when I clicked on the citations to support the claim I found papers on EA. Indeed, the authors even point out that they focus on EA because “this form of acupuncture is easy to standardize.” No kidding. And they should stop calling EA “acupuncture,” because it’s not.

Next up is an amusing little study from the New England School of Acupuncture, led by a naturopath named Keith Spaulding, entitled Acupuncture Needle Stimulation Induces Changes in Bioelectric Potential. It’s a study of 14 healthy volunteers from ages 24 to 52 in which the investigators tried to tell if there were differences in electrical potential attributable to acupuncture based on needle positioning on “real” acupuncture sites and “sham” acupuncture sites:

Randomized clinical trials (RCTs) of acupuncture often include stimulating verum acupoints and nearby so-called “sham” acupoints. Clinical effectiveness has been reported with both verum and sham stimulation. The verum acupuncture is often only marginally better than the sham acupuncture.6–8 This leads researchers to question if sham acupuncture is indeed a physiologically inactive control placebo.9 An electrophysiological correlate of these clinical findings would be eliciting from the sham acupuncture at a nonacupoint a bioelectrical response that is nearly as strong as the bioelectrical response from stimulating a verum acupoint.

The aim of this study was to document changes in the bioelectric potential that occur in response to needling Pericardium 4 (PC 4) and PC 4cont (control) at four sites on the forearm PC 4, a nearby nonacupuncture point (PC4cont) and two distal points (PC 6 and a nearby nonacupoint (PC 6cont) It was hypothesized that a greater bioelectric potential amplitude was induced distal to the point of stimulation only when the needling site was on the acupuncture point and the distal measured site was on the meridian.

One notes that this was not a blinded study, which pretty much sinks it right there. The acupuncturists knew who was getting what, and they decided the depth of insertion of the needles. They could easily have unconsciously inserted needles into the “true” sites in a systematically different way than they did for the “control” sites. Moreover, the placement of the reference electrode in the umbilicus, by the authors’ own admission, produced a “noise floor” acting as an artifact. Even with the lack of blinding, the results of this study are completely underwhelming. Basically, the investigators found that when the PC4 site was stimulated there was a greater response compared to when a control site (a non-accupoint) was stimulated, leading the authors to observe, “A translation phenomenon (an induced polarization) was seen at the distal site when the proximal site was stimulated. At PC 6 with PC 4 stimulated there was a larger amplitude (p<0.05), compared to the control response.” One notes that out of three sets of comparisons, only one was statistically significantly different, and then only with p=0.02. Also, since multiple comparisons were being made (in reality, six sets, rather than three sets of two) one could argue that an adjustment for multiple comparisons should have been made, which might have made the single result obtained no longer statistically significant. Be that as it may, this is hardly a “highly rigorous” study and basically demonstrates nothing.

The remaining studies were even less “interesting.” For instance, there was a study of “laser acupuncture” in depression. (Whenever I hear the term “laser” attached to acupuncture, I can’t help but think of Dr. Evil demanding to have “sharks with frickin’ laser beams attached to their heads,” but that’s just me.) This study looked at functional MRI imaging of patients with and without depression subjected to laser acupuncture on four putative antidepressant acupoints, and concluded:

Laser acupuncture on LR 8, LR 14, and CV 14 stimulated both the anterior and posterior DMN in both the nondepressed and depressed participants. However, in the nondepressed participants, there was consistently outstanding modulation of the anterior DMN at the medial frontal gyrus across all three acupoints. In the depressed participants, there was wider posterior DMN modulation at the parieto–temporal–limbic cortices. This is part of the antidepressant effect of laser acupuncture.

There’s one problem. (Well, there are a lot of problems, but this is the most glaring.) Nowhere could I find out whether the analysis of the fMRI images was blinded; i.e., nowhere does it say whether the radiologists analyzing the images knew which patients were depressed or not or which image series represented patients receiving “real” acupuncture versus sham. Given how finicky interpreting fMRI studies can be and how easily they can show something where there is nothing, blinding of the radiologists analyzing an fMRI study is essential. That’s at a minimum, not even including whether the patients or the practitioners were blinded or not. One would think that if the fMRIs were analyzed in a blinded fashion that the investigators would have mentioned it; so I have to assume that they were not.

Perhaps the most hilariously pointless study in the group was done by a group in Germany and entitled Transcontinental High-Tech Teleacupuncture Studies and Integrative Laser Medicine. Wow. That sure sounds science-y, doesn’t it. Very impressive. But what the heck does it mean? Basically, the investigators studied subjects in China undergoing laser acupuncture therapy and “integrative laser therapy” (whatever that means), as well as EA and regular acupunture, and had the subjects’ electrocardiogram readings transmitted to their facility in Germany at the Medical University of Graz, where they were analyzed. Quite honestly, this is about as pointless a use of telemedicine as I can imagine, and it’s not even that sophisticated. I mean, really. We’re doing telesurgery over thousands of miles now, and all these investigators could do is to transmit ECG data from China to Germany?

I’m not impressed.

There are other articles, of course, all of about the same level of scientific rigor or less. None of them validate acupuncture in any way or provide any compelling evidence for a physiologically plausible mechanism, all of which makes the introduction by Richard C. Niemtzow, MD, PhD, MPH (yes, that Richard C. Niemtzow, the one who has promoted “battlefield acupuncture” for our troops in combat), entitled Basic Science: Mysteries and Mechanisms of Acupuncture, all the more cringe-inducing. First of all, it’s quite telling that Niemtzow begins with a quote from Hamlet (Act 1, Scene V), “There are more things in heaven and earth, Horatio,than are dreamt of in your philosophy.” It’s a Shakespeare quote that quacks love as a means of claiming that science can’t study their quackery. Ironically enough, Niemtzow uses it to introduce a short article in which he tries to paint himself as a hopeless dinosaur dedicated to science:

Every day, acupuncturists insert tiny metal needles into acupuncture points located on meridians, hoping to combat a myriad of clinical pathologies. For the most part, we practitioners are witness to a clinical benefit. Otherwise, physicians would have stopped performing this technique several thousand years ago, and we would not be using it today. However, while we witness healing, none of us has ever seen an acupuncture point let alone a meridian. Modern investigational technology, at its best, fails to provide evidence of these two very basic structures.

One notes that the obvious conclusion from this summary of the existing evidence regarding acupuncture meridians and points is that they do not exist. Somehow, Niemtzow fails to take the logical next step to that conclusion. Instead, he writes:

With this in mind, I know that many of us have asked: “How does acupuncture work?” Perhaps we depended, somewhat, on mythical explanations influenced by the classic readings. When I hypothesized Western mechanisms that might offer an explanation, I was told, by one of my esteemed colleagues, that acupuncture does not follow Newtonian physics. I thought, perhaps, that was an excuse to avoid “drilling” deeper to uncover the same mechanisms that enriched our understanding of allopathic medicine. My wife, who was trained in acupuncture in China, told me that exploring acupuncture on a molecular level to seek an explanation as to “how it works” is, somewhat, a fallacy. She posited that, to understand acupuncture, one most explore its relationships to the environment, animal and plant life, weather, seasons, and the universe. However, I have to admit that I am an “old die hard”; for me, natural events do have scientific explanations and placing a needle in an acupuncture point on a meridian and producing a physiological effect could be understood by using the scientific technology used to understand allopathic medicine.

Good for you, Dr. Niemtzow! Maybe there’s hope for you yet! Or maybe not. In a way, Dr. Niemtzow reminds me of one of the past presidents of the American Association of Naturopathic Physicians, Carl Hangee-Bauer, ND, LAc (note that he’s an acupuncturist as well) taking umbrage at criticisms of naturopathy as unscientific and then declaring his allegiance to rigorous science, even though his practice is rife with what I consider to be pseudoscience, such as traditional Chinese medicine, “biotherapeutic drainage,” detoxification, and others, as well as unproven modalities such as breast thermography. “Science,” Dr. Niemtzow. You keep using that word. I do not think it means what you think it means. (Hint: It does not mean acupuncture.)

Amusingly, in that same editorial, Dr. Niemtzow admits that “a collection of high-quality basic science articles is very difficult to obtain, given the fact that, over the years, we have received and only published a few articles on this topic.” One wonders why not. Could it be because we’re dealing with acupuncture. Sure it could. In any case, it’s hard not to feel a little bit sorry for Dr. Niemtzow. He thinks he’s scientific, while his wife in reality provides a closer approximation of what real acupuncturists think. He also thinks he’s scientifically studying acupuncture, when in fact what he is doing is curating articles designed to validate the treatment rather than to see if there really is anything to it from a scientific standpoint. That fundamental tension makes me wonder when he’ll just give up and let his true proclivities rule.

Original Page: http://www.sciencebasedmedicine.org/index.php/a-very-special-issue-of-medical-acupuncture/

Thursday
Jun062013

89 charged in Medicare fraud busts in 8 cities

Nearly 100 people, including 14 doctors and nurses, were charged for their roles in separate Medicare scams that collectively billed the taxpayer-funded program for roughly $223 million in bogus charges in a massive bust spanning eight cities, federal authorities said Tuesday.

 

It was the latest in a string of similar announcements by Health and Human Services Secretary Kathleen Sebelius and Attorney General Eric Holder as federal authorities crack down on fraud that's believed to cost the program between $60 billion and $90 billion each year. Stopping Medicare's budget from hemorrhaging that money will be key to paying for President Barack Obama's health care overhaul. Sebelius and Holder partnered in 2009 to increase enforcement by allocating more money and staff and creating strike forces in fraud hot spots around the country.

 

Miami, long known as ground zero for the complex scams, was again at the center of Tuesday's busts with 25 people charged for their role in various schemes. Authorities allege five defendants in one scheme bribed Medicare patients for their ID numbers, allowing them to bill for $51 million in home health services that were never given or were not medically necessary.

 

Nearly 20 people, including two doctors, a physician's assistant and two therapists, were charged in various scams in Detroit. In one case, three posed as licensed physicians and wrote bogus prescriptions for drugs and psychotherapy services totaling $12 million, the Health and Human Services and Justice departments said in a statement.

 

In Los Angeles, 13 people were charged in various scams totaling $23 million. In one case, authorities said three people hired workers to recruit Medicare patients. Once the defendants received the patient's Medicare ID numbers, they worked with doctors and medical clinics to get prescriptions for power wheelchairs, which they sold for kickbacks, authorities said in a statement.

 

Roughly 400 agents fanned out across the country as part of Tuesday's arrests raiding businesses, seizing documents and charging 89 suspects in Miami, Los Angeles, Houston, Brooklyn, Detroit, Chicago, Tampa, Fla., and Baton Rouge, La.

 

Four doctors were charged in various scams in Chicago and Brooklyn.

 

Sebelius hailed the Affordable Care Act as one of the best tools we have to "preserve Medicare and protect the tens of millions of Americans who rely on it each day."

 

The law makes it harder for criminals to submit fraudulent Medicare claims and allows the government to suspend payments once they're caught.

 

Medicare fraud has adapted into complex schemes over the years, moving from medical equipment and HIV infusion fraud to ambulance scams, as crooks try to stay one step ahead of authorities. The scams have also grown more sophisticated using recruiters who are paid kickbacks for finding patients, while doctors, nurses and company owners coordinate to appear to deliver medical services that they are not.

 

For decades, Medicare has operated under a pay-and-chase system, paying providers first and investigating suspicious claims later. The system worked when the agency was paying hospitals and institutions that couldn't close up shop and flee the country if they'd been overpaid. Federal authorities are using new technology designed to flag suspicious claims before they are paid, but the system is still in its infancy.

 

Tuesday's bust marks the sixth national Medicare fraud takedown under the strike force teams. Nearly 600 individuals have been charged in schemes involving almost $2 billion, the Health and Human Services and Justice department said.

 

"Taxpayers expect us to work harder and smarter, and that is exactly what happened across the nation today," said Health and Human Services inspector general Daniel R. Levinson.

 

Thursday
Jun062013

Clinical Manager - In Home Rehab Detroit

May 30, 2013

I'd like to invite you to contact us to discuss the newly created position of Clinical Manager for In Home Rehab Detroit.

In this position, you will be responsible for all clinical operations - Physical Therapy and Occupational Therapy - in our 8 Metro Detroit area In Home Rehab Practice locations.

This position will offer you an amazing opportunity to make a difference in the practice and in our professions as you will be very actively involved in setting the strategic and operational direction of our practice.

This is a new position for us at In Home Rehab.  Up until now, we have had supervisory positions in both PT and OT that reported directly to one of our 2 therapist owners.  We are moving to a different leadership model with a Clinical Manager, Business Manager and lead therapist positions in each of the therapy disciplines.

This position has virtually unlimited potential for professional growth and will be strongly supported by our owners. As owners, we plan to continue to be very actively involved in our practice but to focus less on the day to day operations and more on business development = both locally and nationally.

For over ten years, In Home Rehab has been a national leader in geriatric rehabilitative care.  We are active in practice in multiple Metro Detroit locations. Our focus locally is in providing outpatient services within the comfort and convenience of patient homes.  Typically, we set up small but well equipped clinics in Independent Living Centers so our staff and patients have the advantages of outpatient care without the inconvenience of having to travel to a typical outpatient therapy location.  When needed, to insure a continuum of care, we also contract with quality home health care agencies to provide therapy services to our patients while they are under a HHA plan of care. Additionally we have national practices throughout the country that are supported by our headquarters right here in Southeastern Michigan. 

The successful candidate for this position will need to be an experienced Physical or Occupational Therapist with a proven track record of leadership and management. Clinical expertise in Geriatrics and previous experience in Home Care and/or Outpatient services will be needed as this position will also be approximately 50-60% clinical care. Please refer to the enclosed Position Description and In Home Rehab Philosophy for more information.

We are seeking a highly motivated professional who will support and lead our therapy team.  If this sounds like a good job match for you and you would like to discuss this opportunity further, please contact us immediately.  

All the Best

 

Peter R Kovacek, PT, DPT, MSA

voice: (586) 774-5774

fax: (586) 774-5884

www.InHomeRehab.com

 

 

Thursday
May162013

Business Skllls in Physical Therapy: Strategic Marketing, 2nd Edition

Now in the APTA Book Store - Business Skllls in Physical Therapy: Strategic Marketing, 2nd Edition by Peter R. Kovacek, PT, DPT, MSA

http://iweb.apta.org/Purchase/ProductDetail.aspx?Product_code=BS-3-13

I think you will like it.
Wednesday
Apr172013

Jimmo v. Sebelius Settlement Agreement Fact Sheet - CMS

Overview:

Jimmo v. Sebelius Settlement Agreement Fact Sheet

On January 24, 2013, the U. S. District Court for the District of Vermont approved a settlement agreement in the case of Jimmo v. Sebelius, in which the plaintiffs alleged that Medicare contractors were inappropriately applying an “Improvement Standard” in making claims determinations for Medicare coverage involving skilled care (e.g., the skilled nursing facility (SNF), home health (HH), and outpatient therapy (OPT) benefits). The settlement agreement sets forth a series of specific steps for the Centers for Medicare & Medicaid Services (CMS) to undertake, including issuing clarifications to existing program guidance and new educational material on this subject. The goal of this settlement agreement is to ensure that claims are correctly adjudicated in accordance with existing Medicare policy, so that Medicare beneficiaries receive the full coverage to which they are entitled.

Background:

In the case of Jimmo v. Sebelius, the Center for Medicare Advocacy (CMA) alleged that Medicare claims involving skilled care were being inappropriately denied by contractors based on a rule-of- thumb “Improvement Standard”—under which a claim would be summarily denied due to a beneficiary’s lack of restoration potential, even though the beneficiary did in fact require a covered level of skilled care in order to prevent or slow further deterioration in his or her clinical condition. In the Jimmo lawsuit, CMS denied establishing an improper rule-of-thumb “Improvement Standard.” The Court never ruled on the validity of the Jimmo plaintiffs’ allegations.

While an expectation of improvement would be a reasonable criterion to consider when evaluating, for example, a claim in which the goal of treatment is restoring a prior capability, Medicare policy has long recognized that there may also be specific instances where no improvement is expected but skilled care is, nevertheless, required in order to prevent or slow deterioration and maintain a beneficiary at the maximum practicable level of function. For example, in the regulations at 42 CFR 409.32(c), the level of care criteria for SNF coverage specify that the “. . . restoration potential of a patient is not the deciding factor in determining whether skilled services are needed. Even if full recovery or medical improvement is not possible, a patient may need skilled services to prevent further deterioration or preserve current capabilities.”

The Medicare statute and regulations have never supported the imposition of an “Improvement Standard” rule-of-thumb in determining whether skilled care is required to prevent or slow deterioration in a patient’s condition. A beneficiary’s lack of restoration potential cannot, in itself, serve as the basis for denying coverage, without regard to an individualized assessment of the beneficiary’s medical condition and the reasonableness and necessity of the treatment, care, or services in question. Conversely, coverage in this context would not be available in a situation where the beneficiary’s care needs can be addressed safely and effectively through the use of nonskilled personnel.

Thus, such coverage depends not on the beneficiary’s restoration potential, but on whether skilled care is required, along with the underlying reasonableness and necessity of the services themselves. Any Medicare coverage or appeals decisions concerning skilled care coverage must reflect this basic principle. In this context, it is also essential and has always been required that claims for skilled care coverage include sufficient documentation to substantiate clearly that skilled care is required, that it is in fact provided, and that the services themselves are reasonable and necessary, thereby facilitating accurate and appropriate claims adjudication.

The Settlement Agreement - No Expansion of Medicare Coverage:
The Jimmo v. Sebelius settlement agreement itself includes language specifying that “Nothing in this Settlement Agreement modifies, contracts, or expands the existing eligibility requirements for receiving Medicare coverage.”

The settlement agreement is intended to clarify that when skilled services are required in order to provide care that is reasonable and necessary to prevent or slow further deterioration, coverage cannot be denied based on the absence of potential for improvement or restoration. As such, any actions undertaken in connection with this settlement do not represent an expansion of coverage, but rather, serve to clarify existing policy so that Medicare claims will be adjudicated consistently and appropriately.

Forthcoming Activities:

CMS plans to conduct the following activities under the terms of the settlement agreement:

Clarifying Policy – Updating Program Manuals

The first action CMS will undertake as specified in the settlement agreement will be revising the relevant program manuals used by Medicare contractors. The Medicare program manuals will be reworded for clarity, so as to reinforce the intent of the policy. Specifically, in accordance with the settlement agreement, manual revisions will clarify that coverage of therapy “...does not turn on the presence or absence of a beneficiary’s potential for improvement from the therapy, but rather on the beneficiary’s need for skilled care.”

Educational Campaign – Informing Stakeholders

The next step CMS will take will be an educational campaign for contractors, adjudicators, and providers and suppliers. CMS will disseminate to these recipients a variety of written materials, including:

Program Transmittal;
Medicare Learning Network (MLN) Matters article; Updated 1-800 MEDICARE scripts.

CMS will also conduct national conference calls with providers and suppliers as well as Medicare contractors, Administrative Law Judges, medical reviewers, and agency staff, to communicate the policy clarifications described herein and answer questions.

Claims Review

In addition, to ensure beneficiaries receive the care to which they are entitled, CMS will engage in accountability measures, including review of a random sample of SNF, HH, and OPT coverage decisions to determine overall trends and identify any problems, as well as a review of individual claims determinations that may not have been made in accordance with the principles set forth in the settlement agreement.

According to the terms of the settlement agreement, CMS will complete the manual revisions and educational campaign by January 23, 2014, which is within one year of the approval date of the settlement agreement.