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Bloodletting: a good reason to discard disproven therapies

Bloodletting: a good reason to discard disproven therapies

All of us at SBM have repeatedly expressed frustration at the continuing influx of pseudoscience into the health care system. Judging from comments posted on this site and private communications we receive, our readers share this frustration but are at a loss to figure out how to get through to legislators and other policy makers. Unlike naturopaths and chiropractors, we don’t have the money to hire professional lobbyists. Fortunately, an opportunity to sound off against SCAMs has presented itself, completely free of charge.

How?

Now that the Affordable Care Act enrollment debacle is dying down, the Department of Health and Human Services (HHS) is turning its attention to divining just what the heck Section 2706 of the ACA, the non-discrimination provision, means. (Actually there are other federal agencies involved; to simplify things, here we’ll refer to them collectively as “HHS.”) HHS has opened the issue to public comment, but only until June 10. Let’s take a look at why this is important and what you can do about it.

(There are providers other than chiropractors, naturopaths and acupuncturists involved in this fight. For example, you’ll see public comments from nurse anesthetists and nurse practitioners. But I’m not worried about providers who stick to science.)

I’ve discussed Section 2706 before, but a brief review is in order. Here’s what it says:

(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 was inserted into the ACA under the stewardship of Sen. Tom Harkin, whose CAM-friendly inclinations are well known. It was not in the original ACA bill but became part of the Senate’s version without the benefit of any sort of committee hearing. Perhaps that was by design.

Via a set of “FAQs,” HHS issued its interpretation of Section 2706’s requirements for the guidance of insurance companies devising ACA-compliant health care benefits:

to the extent an item or service is a covered benefit under the plan or coverage, and consistent with reasonable medical management techniques specified under the plan with respect to the frequency, method, treatment or setting for an item or service, a plan or issuer shall not discriminate based on a provider’s license or certification, to the extent the provider is acting within the scope of the provider’s license or certification under applicable state law. The FAQ also states that section 2706(a) of the PHS Act [that is, the ACA] does not require plans or issuers to accept all types of providers into a network and also does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.

Sen. Harkin was not pleased. Here’s what HHS was told by a Senate Committee:

The goal of this provision is to ensure that patients have the right to access covered health services from the full range of providers licensed and certified in their State. The Committee is therefore concerned that the FAQ document issued by HHS … advises insurers that this nondiscrimination provision allows them to exclude from participation whole categories of providers operating under a State license or certification. In addition, the FAQ advises insurers that section 2706 allows discrimination in the reimbursement rates based on broad ‘market considerations’ rather than the more limited exception cited in the law for performance and quality measures. Section 2706 was intended to prohibit exactly these types of discrimination.

HHS is asking for your help in resolving this dilemma:

Pursuant to this [Senate] report, the Departments are requesting comments on all aspects of the interpretation of section 2706(a) of the [the ACA]. This includes but is not limited to comments on access, costs, other federal and state laws, and feasibility.

But, again, you have to comment by June 10, so get going.

How the state legislators got us into this mess

First, I suggest that HHS and the public be made aware of the extent of damage Section 2706 might do as it has been interpreted by Sen. Harkin’s committee. They need background, and you are just the person to give it to them.

Of course, CAM providers have always depended on government largesse to survive, whether it be NCCAM-funded studies (none of which CAM practitioners apparently paid the least bit of attention to), state licensing, Medicare coverage (of chiropractic, for the detection and correction of subluxations), state insurance coverage mandates and Medicaid coverage. (Washington just became the third state to include naturopaths in Medicaid. Naturopaths are also lobbying for Medicare coverage, a subject I’ll return to in a later post.) There are also government-backed student loans, as well as DSHEA and the legalization of fraudulent homeopathic remedies. Section 2706 is just another example of substituting political clout for the rational application of science to health care practices. Or, put another way, it pours the public’s money into the coffers of practitioners of pseudoscience.

As we’ve talked about before, chiropractors, naturopaths and acupuncturists are all claiming, to some degree or another, that they are primary care physicians. (Both Harriet Hall and I have discussed the deficiencies of chiropractors as PCPs, and Mark Crislip took on the naturopaths.) Acupuncturists seem sort of half-hearted about it, but DCs and NDs are dead serious, especially the latter. And it is here that the profligacy of the state legislatures in defining DC, ND and acupuncturists‘ scope of practice comes home to roost.

In para materia

First and foremost, Section 2706 must be read as one part in a larger whole. (Or, as the lawyers would say, in para materia with the entire ACA.)

In interpreting Section 2706, HHS must keep in mind the overarching purpose of the ACA, as well as the fact that it is but one paragraph in nearly 1,000 pages of text. As the U.S. Supreme Court said in National Federation of Independent Business v. Sebelius:

The Act aims to increase the number of Americans covered by health insurance and decrease the cost of health care. The Act’s 10 titles stretch over 900 pages and contain hundreds of provisions.

Obviously, Section 2706 does nothing to fulfill the Act’s intent of increasing the number of covered Americans. But its provisions can be judged against the goal of decreasing the cost of health care. Of course, decreasing costs must be measured against outcomes. As Harriet Hall has pointed out, eliminating health care altogether would reduce costs to zero. What we are really seeking here is cost effectiveness.

For example, the Patient-Center Outcomes Research Institute (PCORI)’s purpose is (as described by the Urban Institute Health Policy Center, citations omitted):

There are a number of other provisions in the ACA that have the potential to contain costs. The ACA authorizes the establishment of a nonprofit corporation, the Patient-Centered Outcomes Research Institute, to conduct and broadly disseminate comparative-effectiveness research. This research effort is intended to inform “patients, clinicians, purchasers, and policy-makers in making informed health decisions” regarding relative health outcomes, clinical effectiveness, and appropriateness of medical treatments and services.

A mechanical application of Section 2706 without considering cost effectiveness sacrifices the larger goals of the Act for the private gain of individual practitioners and political ideology. Which brings up an interesting possibility. What if there is no evidence that chiropractors, naturopaths or acupuncturists can deliver cost-effective care? What happens then?

In one sense, forcing inclusion of CAM providers is already undermining the market-oriented managed competition strategy employed by the ACA. Insurers are already offering ACA-compliant plans, as required by law, under the assumption that CAM providers need not be included. To the extent these plans do not include chiropractors, naturopaths and acupuncturists, it reflects a decision by insurers that these practitioners are not able to offer health care services required by the Act at the best price for the result achieved. Obviously, were that not the case, CAM practitioners would have been included in provider panels. Mandating inclusion will send insurers scrambling to recalibrate plan benefits and costs, another glitch in the system we don’t need.

Essential health benefits

The ACA’s tying cost reduction, in part, to improved health outcomes, is based on the theory that healthier people will utilize fewer health resources and that catching a problem early reduces the need for more expensive treatment down the line. In order to achieve these goals, the ACA requires coverage of “essential health benefits:”

  1. Ambulatory patient services
  2. Emergency services
  3. Hospitalization
  4. Maternity and newborn care
  5. Mental health and substance use disorder services
  6. Prescription drugs
  7. Rehabilitative and habilitative services and devices
  8. Laboratory services
  9. Preventive and wellness services and chronic disease management
  10. Pediatric services, including oral and vision care

The ACA centers the delivery of these services on the patient’s “medical home,” which is headed by a primary care physician, who coordinates the patient’s care. Chiropractors and acupuncturists, despite claims to the contrary, cannot provide the full scope of primary care required by the ACA. Naturopaths claim, falsely, that they have the education and training to practice as PCPs and they are, in fact, licensed as primary care practitioners in a handful of states, although they do not have hospital privileges. They are covered Medicaid providers in three states but are not covered by Medicare.

The fact that naturopaths are licensed as PCPs in a few states does not override the ACA’s primary concern with reduced costs and improved outcomes. The truth of the matter is that naturopaths do not practice evidence-based medicine and the majority of their treatments are not supported by an acceptable level of evidence or, for that matter, any evidence at all. In fact, some of the mainstays of naturopathic practice are thoroughly discredited, such as colonic irrigation homeopathy, the use of dietary supplements to manage many diseases, and the like. There is evidence, however, that naturopathic care results in worse outcomes. Most disturbing is the naturopaths’ opposition to vaccination, an opposition that sees its logical outcome in the association between naturopathic care and undervaccination, as well as an increased risk of acquiring a vaccine-preventable disease.

In short, despite their claims otherwise, there is simply no evidence that naturopaths can safely and effectively (much less cost-effectively) diagnose and treat the undifferentiated patient, a basic skill necessary for all primary care practitioners. (Basically, the undifferentiated patient is any person of any age with any condition who might walk in the door.) In fact, there is only one study in all of the medical literature which purports to show a benefit to naturopathic care. Even there, patients were under the care of a medical doctor and naturopathic care was in addition to usual care, and, in fact, there was nothing in their care that was uniquely naturopathic or could not have been provided by any other medical professional.

Even where specialty care is concerned, chiropractors and acupuncturists suffer from a similar dearth of evidence and the risk that patients will be exposed to unproven and disproven diagnoses and treatments. For example, some chiropractors continue to diagnose and treat “subluxations”, a thoroughly discredited prescientific notion that the human spine requires “adjustments” to “misaligned” vertebrae to maintain health. (This has been a huge cost burden on Medicare.) To be fair, other chiropractors limit themselves to evidence-based treatment of musculoskeletal problems. However, insurers would do well to institute a detailed vetting process to choose only those willing to stick to the evidence.

There is simply no reliable evidence that acupuncture is effective for any condition. Even the National Center for Complementary and Alternative Medicine admits acupuncture may be no more than an elaborate placebo. (Actually, that is exactly what it is.) Yet, given their full range of options under state practice acts, acupuncturists subject their patients to all sorts of prescientific practices like moxibustion and “Kirlian photography.”

Harkin’s folly

Thus the folly of Section 2706’s premise – that simply because a state has given a particular type of practitioner a broad scope of practice, those practitioners can deliver safe and cost-effective health care commensurate with their practice act – is fully revealed. We already have a substantial body of evidence (some of it from the federal government itself, via NCCAM) that the services CAM providers offer do not improve health outcomes, yet Section 2706 forces insurers to include these practitioners. Given this, insurers must be given wide latitude to exclude practices that do not benefit, and may in fact harm, the insured. Yet, this remedy itself poses its own problems.

Another cost control measure imposed by the ACA is a limitation on the percentage of administrative costs an insurer can include in premiums. When contracting with medical doctors and allied health professions such as nurses and physical therapists, insurers can rely on a body of medical literature that either includes or excludes diagnoses and treatments based on the current evidence. Chiropractors, naturopaths and acupuncturists, however, have the liberty of simply creating new diagnoses and treatments out of whole cloth, unhindered by basic scientific plausibility, much less published literature supporting or rejecting it. It is thus that CAM providers have come up with such novel diagnoses and treatments as IV vitamins for flu prevention and other IV “cocktails”, functional endocrinology, chronic yeast overgrowth, adrenal fatigue, green tea suppositories for cervical dysplasia, treatment of disease with homeopathy, organ repositioning, applied kinesiology, food “intolerance” testing, cranial sacral therapy and moxibustion to name just a few.

If all insurers are forced to include CAM practitioners in their provider panels, they will have to be eternally vigilant in excluding these exotic creations, thereby simply adding to administrative costs. They must already do this to a certain extent due to state insurance mandates, but Section 2706 simply compounds the problem by increasing the number of CAM providers which must be included. (While chiropractors often have insurance mandates in their favor, naturopaths and acupuncturists generally do not. There are exceptions, however, such as Washington state.)

Given all of this, it is clear that Section 2706 undermines the very purposes of the ACA and should be repealed. But we don’t get to decide that, nor does HHS. The best we can go for at this point is damage control. Here’s what I recommend:

  • Issue a report setting forth the dilemma caused by Section 2706 (see above) and use this as a basis for stringent limitations on coverage of CAM provider services.
  • Allow insurers to require that all providers sign an agreement that they will employ evidence-based practices. Breach of the agreement is grounds for exclusion from the provider panel.
  • Further allow insurers to require that all providers advise patients to follow CDC-recommended schedules for vaccination and prohibit them from advising patients not to vaccinate based on discredited reasons. Again, failure to follow the rules should be grounds for exclusion from the panel.
  • Make it clear that chiropractors, naturopaths and acupuncturists cannot advise patients to ignore their medical doctors’ advice unless there is an evidence-based reason for doing so.
  • Make it clear that no medical doctor is ever required to compromise his or her judgment by referring to a practitioner when he or she feels that doing so is not in the best interest of the patient. For example, medical doctors should be free to refer to physical therapists instead of chiropractors.
  • Allow insurers to institute preventive measures to combat the bundling of unproven treatments with covered services. For example, make it clear that treatment of a cold by a naturopath will not be covered if the naturopath uses that time to advise patients to use (or sells) unproven treatments like homeopathy, dietary supplements and herbs.

Feel free to comment on the HHS’s website by using any, all or none of this post. (You can certainly add your own reasons.) Even if you don’t think HHS will pay a bit of attention, you’ll feel so much better afterwards. Click here to proceed.

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  • Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.    

Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the Society for Science-Based Medicine (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She tracks state and federal bills that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived here.