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Obamacare and CAM II: Discrimination (or not) against CAM

Supporters of science-based medicine have expressed concern over this provision in the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA.”):

SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.

(a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

Section 2706 (now codified as 42 U.S.C. Sec. 300gg-5) goes into effect in 2014 and covers virtually all individual and group insurance market policies, although it is not clear whether it will apply to existing policies “grandfathered” in 2010 by the ACA.

Section 2706 was not part of the U.S House of Representatives version of the ACA but was included in the Senate version (which ultimately passed) under the guidance of (surprise!) Sen. Tom Harkin (D-Iowa). It was heavily lobbied by the American Chiropractic Association and other “CAM” providers, as well as some “conventional” providers like nurse anesthetists and optometrists. The legislative history (reports, committee minutes, floor debates and the like which precede a vote on a bill) indicates it was specifically included to prevent discrimination against CAM providers.  This is of obvious concern to anyone who supports science-based, or for that matter evidence-based, medicine, as there is nothing to indicate that scientific plausibility or evidence (or the lack thereof) actually affects CAM practices. It should also concern insurers and those who pay for insurance (employers and individuals) to the extent it might require payment for CAM treatments, as ineffective treatments will negatively affect their bottom line. The U.S. Departments of Health and Human Services (HHS) and Labor and the Treasury Department, which are charged with issuing regulations implementing the ACA, have not yet promulgated regulations for Section 2706. The American Medical Association House of Delegates has already passed a resolution seeking its repeal.

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Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

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Physicians and “CAM”

In the last 20 or so years, the popularity of so-called “complementary and alternative medicine” began to lure physicians (M.D.s and D.O.s) into employing CAM treatments, or what is now rebranded as “integrative medicine.” Of course, CAM use by a physician necessarily requires some deviation from the “conventional” standard of care. Because deviation from the standard of care can be grounds for discipline by the state medical board, state legislatures and medical boards in the United States have had to grapple with just how much medical practice acts and regulations should accommodate CAM use by physicians.

As it turns out, less than you might think.

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Posted in: Legal, Politics and Regulation, Science and Medicine

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The DC as PCP? Revisited

There is a disturbing effort afoot to rebrand chiropractors as primary care physicians, a subject both Harriet Hall and I have discussed in previous posts. Part of this effort includes convincing state legislatures to grant prescription privileges to chiropractors, an effort that succeeded in New Mexico, as reported in a post a couple of years ago. Let’s return to New Mexico and see how that is working out for everyone.

By way of background, in 2008, the New Mexico legislature created a new iteration of chiropractor called “certified advanced practice chiropractic physicians” with the authority to

prescribe, administer and dispense herbal medicine, homeopathic medicines, vitamins, minerals, enzymes, glandular products, naturally derived substances, protomorphogens, live cell products, gerovital, amino acids, dietary supplements, foods for special dietary use, bioidentical hormones, sterile water, sterile saline, sarapin or its generic, caffeine, procaine, oxygen, epinephrine and vapocoolants.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Acupuncture practice acts: legalized quackery

As Ben Kavoussi observed recently,

[o]nce considered archaic and obsolete, Oriental Medicine has greatly benefited from the postmodern attitudes towards science and knowledge. This is because postmodernists consider the ‘truth’ as being relative to one’s viewpoint or stance. They do not see science as a superior process of acquiring knowledge, but as a ‘belief system,’ a ‘language game,’ which does not give more access to truth than other conceptual constructs.

This “postmodern fallacy,” he continued,

has allowed the return of mass professional delusions under the label of Chinese, Oriental or Asian Medicine. As an unfortunate byproduct, dangerous and outdated therapies have been legitimized, and quacks and charlatans can overtly defraud those who cannot distinguish scientific medicine from lore and fantasy.

There is probably no better example of this “unfortunate byproduct” than the state acupuncture and oriental medicine practice acts. These laws have indeed legitimized dangerous and outdated therapies, allowing quacks and charlatans to defraud the public.

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Posted in: Acupuncture, Legal, Politics and Regulation, Traditional Chinese Medicine

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Stem cell therapy regulation plays catch up

The burgeoning U.S. stem cell therapy industry was delivered a setback last month in the form of a U.S. District Court injunction against use of the “Regenexx™ Procedure,” which purports to treat joint, muscle, tendon or bone pain due to injury or other conditions. The court agreed with the FDA that the cell product used in the procedure is both a drug and a “biological product” subject to FDA regulation. Because a similar process is used in other stem cell therapies the decision increases the possibility that the FDA will take a like position in other cases.

The general term “stem cell therapy” comprises an array of treatments which range from the clinically proven to quackery. On one end of the spectrum is blood stem cell transplantation to treat diseases and conditions of the blood and immune system. On the other lies the kind of stem cell therapy tourism addressed by both Steve Novella (here and here) and Orac (here and here), which involves the injection of what may, or may not be, stem cells from what may, or may not be, humans. In between fall therapies which are plausible and have promise but have not been adequately tested in clinical trials. There is a concern that these therapies are being oversold by clinics which charge thousands of dollars (not reimbursed by insurance) to treat conditions including multiple sclerosis, musculoskeletal pain, and cardiac disease.

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Posted in: Legal, Medical Ethics, Politics and Regulation, Science and Medicine

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NCCAM manipulates spinal manipulation

“Complementary and alternative medicine,” as pediatrician and fellow blogger John Snyder aptly stated in a recent journal article on CAM and children,

is a term used to describe a disparate, poorly defined set of practices and treatment modalities presumed to be distinct from so-called ‘conventional medicine’.

As we have discussed here at Science-Based Medicine, this amorphous concept facilitates a convenient fluidity in delineating the parameters of CAM. Without a clear definition, CAM (and integrative medicine) proponents are able to rebrand plausible and evidence-based practices such as diet, exercise and relaxation as CAM, a tactic we at SBM call “bait and switch.” This results in inflation in the figures of CAM use (important because CAM is all about popularity) and claims that CAM “works.”

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Posted in: Chiropractic, Politics and Regulation

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Obamacare and CAM

Practitioners of so-called “complementary and alternative medicine” currently enjoy a certain measure of government largesse in the form of state laws mandating coverage of their services by private health insurance plans. The federal Patient Protection and Affordable Care Act (often referred to as the Affordable Care Act, or “ACA,” and sometimes as “Obamacare”) has the potential of putting a significant dent in this forced coverage of pseudoscientific health care.

All states require private health insurers to cover certain health care services by law. These mandates can be in the form of requirements that specific health care services or treatments be covered, that certain providers be covered, or that certain populations be covered.

Mandates are ubiquitous, inconsistent among states and costly. One insurance industry trade group calculates that there are currently 2,262 separate state mandates. Some are supported by clear evidence of benefit, such as immunizations and mammograms. Others, unfortunately, require coverage of “CAM” services, such as acupuncture and chiropractic. (In fact, acupuncture is typically not covered by small group plans unless required by state mandate.) Whether beneficial or not, all agree that these mandates increase premium costs to the consumer, most estimated to be from less than one percent to five percent of premiums, depending on the mandate. Chiropractic coverage, for example, can vary from state to state, from limiting the insured to a specific number of visits per year all the way to requiring chiropractors to be covered on par with medical doctors.

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Posted in: Acupuncture, Chiropractic, Legal, Politics and Regulation, Science and Medicine

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Dept. of Education to Council on Chiropractic Education: “Straighten Up!”

Our last look at the Council on Chiropractic Education (CCE), about 18 months ago, found the CCE deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. Today we offer an update on that situation.

Update: the CCE is deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges.

As you may recall, the CCE, which accredits chiropractic colleges in the U.S., stood accused of removing the subluxation from its standards for accreditation, so that chiropractic students would no longer be required to learn how to “detect” and “correct” the putative vertebral subluxation. Of course, the chiropractic subluxation doesn’t exist, but we’ll get to that in a minute. This brouhaha was raised by the more traditional wing of the chiropractic community, called “straights,” whose practice (and livelihood) is based on convincing patients that their spines need “adjustments” to remove these subluxations under the threat of ill health should they be left unattended. The straights were also upset at the move by another faction of chiropractic seeking to rebrand chiropractors as primary care physicians who diagnose and treat a wide variety of diseases and conditions.

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Posted in: Chiropractic, Legal, Politics and Regulation

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Legislative Alchemy: 2012.5

Legislative alchemy, as faithful SBM readers know, is the process by which state legislatures and Congress take scientifically implausible and unproven treatments and diagnostic methods and turn them into licensed health care practices and legally sold products. Previous posts have explored this phenomenon in naturopathychiropractic and acupuncture.

Our last report on the legislative efforts of CAM providers appeared almost six months ago, the beginning of the legislative year for many states. Now, most legislatures have shuttered the statehouse doors and gone home. So let’s see how the CAM practitioners are doing this year.

Naturopathy

A goal of the American Association of Naturopathic Physicians (AANP) is “full scope of practice” in all 50 U.S. states. They’ve got a ways to go. Naturopaths are currently licensed to practice in only 17 states and the District of Columbia. Bills to expand licensure failed to make it out of committee again during the 2012 legislative sessions of two states, Iowa and Maryland. In Colorado and Virginia, where licensing bills failed to pass in previous years, no new legislation was introduced to license naturopaths in 2012. Bills to license naturopaths are still pending before legislative committees in Illinois, Massachusetts, Michigan, North Carolina, New York and Pennsylvania. However, in North Carolina and Pennsylvania these bills have been languishing in committee since 2011, making passage appear less likely This is especially true in North Carolina, where the legislative session ends soon.

Another strategy of the AANP is “progressive legislation.” This means that while some compromise in initial licensing legislation may be necessary to get a licensing bill passed, successive attempts can cure any initial disappointments through expansion of scope of practice and insurance coverage, for example. Nowhere was this strategy more successful in 2012 than in Vermont, where “naturopathic physicians” (as the Vermont Legislature calls them) were officially defined as “primary care providers” (PCPs) for the purpose of health insurance coverage. The new law means that naturopathic physician practices can qualify as patient “medical homes” under the state’s Blueprint for Health and that they may practice as such independently and without supervision.

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Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation

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POM: Not So Wonderful

“POM Wonderful” is a brand of pomegranate juice. It is manufactured by a company owned by Linda and Stewart Resnick, California billionaires who pretty much single-handedly created a multi-million dollar market for pomegranate juice where none existed before. Or, as LA Times columnist Michael Hilzik wrote,

It has long been clear that the most wonderful thing about Pom Wonderful pomegranate juice is the spectacular marketing skill that persuades consumers to fork over their hard-earned cash for a liquid that sells for five to six times the price of, oh, cranberry juice.

He’s right about the expense: a daily 8 oz. dose of POM Wonderful juice costs about $780 annually according to a recent Federal Trade Commission case, which we’ll get to soon.

The Resnicks parlayed their success selling pomegranate juice into two additional products, both dietary supplements, in the form of POMx pills and POMx liquid. The Resnicks and their companies have shelled out $35 million in sponsored research to determine what health benefits might arise from ingesting pomegranate juice or its components, research they have not been shy about using in touting their products. The couple apparently has a flair for taking the mundane and making it appear, well, wonderful to the consumer – they also own Fiji Water and the Franklin Mint, among other business interests.

In 2010, the Federal Trade Commission (FTC) filed a complaint against Resnicks, one of their business partners, and two of their companies (which I’ll refer to collectively as “POM”), alleging unfair and deceptive trade practices. POM, according to the FTC complaint, made false and misleading claims that its POM products treat, prevent, and reduce the risk of heart disease, prostate cancer and erectile dysfunction.

An Administrative Law Judge (ALJ) agreed with the FTC and on May 17, 2012, issued a 335-page decision and cease and desist order, ruling POM lacked competent and reliable scientific evidence that drinking 8 ounces of POM Wonderful Juice daily, or taking one POMx pill, or one teaspoon of POMx liquid, treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction. In the Matter of POM Wonderful, LLC, et al., F.T.C. No. 9344 (May 17, 2012).

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Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Politics and Regulation

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