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Consumer Health Digest #20-09
March 8, 2020
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.htmlIt summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.
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Medicare acupuncture coverage for chronic low back pain criticizedThe Centers for Medicare & Medicaid Services (CMS) has announced that it will cover acupuncture for chronic low back pain for up to 12 visits in 90 days and no more than 20 visits annually for Medicare beneficiaries.
[Decision memo for acupuncture for chronic low back pain (CAG-00452N)
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=295. CMS. Jan 21, 2020]
The coverage applies to acupuncture furnished by: (a) physicians in accordance with applicable state requirements and (b) physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel (under the appropriate level of supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist) if they meet all applicable state requirements and have:
* a masters or doctoral level degree in acupuncture or Oriental medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); and
* a current, full, active, and unrestricted license to practice acupuncture in a State, Territory, or Commonwealth (i.e. Puerto Rico) of the United States, or District of Columbia
Dr. Edzard Ernst noted that the decision to cover acupuncture for chronic low back pain is not based on solid randomized clinical trial (RCT) evidence.
A recent synthesis of systematic reviews of relevant clinical trials concluded: "Evidence suggests that there are insufficient high‐quality CRTs to judge the efficacy of acupuncture for low back pain."
[Paley CA. Johnson MI. Acupuncture for the relief of chronic pain: a synthesis of systematic reviews
https://www.mdpi.com/1010-660X/56/1/6/htm. Medicinal. 56(1), 6, 2020]
Commenting on the report, Dr. Ernst wrote: "Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management."
[Ernst E. Acupuncture for the relief of chronic pain? A new, thorough synthesis fails to produce strong evidence that acupuncture works
https://edzardernst.com/2020/01/acupuncture-for-the-relief-of-chronic-pain-a-new-thorough-synthesis-fails-to-produce-strong-evidence-that-acupuncture-works/. EdzartErnst.com
http://edzarternst.com/. Jan 3, 2020]
Last year, he opined that Medicare reimbursement for low back pain was unjustified and noted that the UK's National Institute for Health Care Excellence concluded
https://www.nice.org.uk/news/article/nice-publishes-updated-advice-on-treating-low-back-pain in 2016 that it was no better than sham treatment.
[Ernst E. Acupuncture is effective for chronic back pain!!! If you disagree, tell the CMS
https://edzardernst.com/2019/01/acupuncture-is-effective-for-chronic-back-pain-if-you-disagree-tell-the-cms/. EdzardErnst.com
http://edzardernst.com/. Jan 26, 2019]
Last year, CMS said that additional research would be needed in order to make a favorable coverage determination. However, attorney Jann Bellamy has noted that the recent decision was not based on additional evidence. She also bemoaned recent scope-of-practice expansions for acupuncturists in Oklahoma, West Virginia, Maine, Massachusetts, Michigan, and Washington as well as new bills to expand practice in Rhode Island and Washington.
[Bellamy J. Legislative alchemy 2019: acupuncturists score Medicare coverage and scope of practice expansion
https://sciencebasedmedicine.org/legislative-alchemy-2019-acupuncturists-score-medicare-coverage-and-scope-of-practice-expansion/. Feb 13, 2020]
Dr. Stephen Barrett and Professor William M. London have criticized the teachings in "oriental medical schools"
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/1681259 of fanciful traditional Chinese medicine concepts that conflict with scientific knowledge of anatomy, physiology, and pathology. In 2018, retired family practice physician Dr. Harriet Hall criticized the American Academy of Family Physicians
https://sciencebasedmedicine.org/aafp-promotes-acupuncture/ for violating its own continuing medical education (CME) standard for evidence-based, objective, and balanced content by promoting a CME monograph on musculoskeletal therapies that recommends acupuncture as first-line therapy for chronic back pain and other pain conditions, and also promotes dry needling
https://sciencebasedmedicine.org/dry-needling/ and cupping
https://sciencebasedmedicine.org/cupping-olympic-pseudoscience/. Acupuncture Watch
https://quackwatch.org/acupuncture/ has additional criticisms of acupuncture.
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Comments needed about FDA homeopathy policyIn October 2019, the Food and Drug Administration (FDA) called for public comments about its revised draft guidance document for FDA staff and industry titled "Drug Products Labeled as Homeopathic."
https://www.fda.gov/media/131978/download The revised document indicates that FDA intends to give regulatory priority to unapproved homeopathic
https://www.homeowatch.org/ products that raise safety concerns, are intended to prevent or treat serious health problems, or are intended for use by vulnerable populations.
The proposed policy fails to clearly indicate that:
(a) homeopathic principles make no sense in light of scientific progress since homeopathy was proposed in the late 1700s,
(b) there is no evidence that homeopathic products can prevent or treat any medical condition, and
(c) there is no justification for exempting homeopathic products from premarket approval.
However, a complete ban is probably not politically feasible because Congress might overturn it. Dr. Barrett would like the FDA to:
* limit the marketing of homeopathic products to single-ingredient products that strictly comply with the Homeopathic Pharmacopeia
* permit no health claims without approval through the FDA's standard drug approval process
* require premarket approval for products that combine a homeopathic ingredient with any other ingredient (homeopathic or not)
for unapproved products,
* limit the information in labeling or advertising to the monograph (chemical) name, the dilution, and that fact that the product is homeopathic
advise consumers not to buy homeopathic products
* give high priority to ridding the marketplace of "electrodermal screening" devices that are used to misdiagnose disease and sell products
[Barrett S. FDA homeopathic product regulation
https://quackwatch.org/homeopathy/reg/fda_hearing_2015/comment. Homeowatch, April 17, 2015]
So far, more than 50,000 comments have been received
https://www.regulations.gov/docket?D=FDA-2017-D-6580, most of them generated by Homeopathy for Choice and other homeopathic groups that claim that access to homeopathic products is at risk. This claim is false because the FDA has expressed no interest in a ban.
Dr. Barrett believes it would be useful for the FDA to receive comments that support his suggestions. Comments can be submitted electronically until March 23, 2020
https://www.regulations.gov/document?D=FDA-2017-D-6580-4828###
Commutation for Medicare fraudster blastedAmong President Donald Trump's much-publicized recent clemency actions was the commutation of the 35-year sentence of Judith Negron, a Miami mental health care business co-owner who turned down a plea deal in 2011 and was convicted by a jury on 24 counts of defrauding Medicare. The counts included conspiracy to commit health-care fraud, health-care fraud, conspiracy to pay and receive illegal health-care kickbacks, conspiracy to commit money laundering, money laundering, and structuring to avoid reporting requirements. Her co-owners Lawrence Duran and Marianella Valera, who made plea deals, were sentenced to 50 years and 35 years, respectively, for their roles in the scheme, but their sentences were not commuted. Negron's conviction came amid a 13-year effort by the Justice Department's and Department of Health and Human Service's Medicare Fraud Strike Force to combat serious health-care fraud. Matthew J. Smith, executive director of the Coalition Against Insurance Fraud said that letting Negron "walk out the door after a judicial trial, after a judicial sentence, runs entirely counter to the hard work, dedication and effort that DOJ and state fraud fighters have devoted to cracking down on Medicare fraud."
[Clemency for Medicare fraudster belies justice enforcement push
https://news.bloomberglaw.com/health-law-and-business/clemency-for-medicare-fraudster-belies-justice-enforcement-push. Bloomberg Law. Feb 20, 2020]
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Quackwatch joins Center for Inquiry.The Center for Inquiry is now maintaining the Quackwatch network of Web sites and will receive Dr. Stephen Barrett's research library later this year.
[Quackwatch joins the Center for Inquiry
https://centerforinquiry.org/press_releases/quackwatch-joins-the-center-for-inquiry/. Center for Inquiry news release. Feb 26, 2020]
The Center for Inquiry (CFI
https://centerforinquiry.org/) is a nonprofit educational, advocacy, and research organization headquartered in Amherst, New York, with executive offices in Washington, D.C. It is also home to the Richard Dawkins Foundation for Reason & Science, the Committee for Skeptical Inquiry, and the Council for Secular Humanism.
The Center for Inquiry strives to foster a secular society based on reason, science, freedom of inquiry, and humanist values.
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Refunds announced for consumers defrauded by brain-boosting claimsThe Federal Trade Commission (FTC) has announced that it is mailing 27,174 refund checks totaling over $551,000 to consumers who purchased deceptively marketed "cognitive improvement" supplements.
[FTC refunding consumers defrauded by cognitive improvement claims
https://www.ftc.gov/news-events/press-releases/2020/02/ftc-refunding-consumers-defrauded-cognitive-improvement-claims. FTC press release. Feb 25, 2020]
According to the FTC's April 2019 complaint
https://www.ftc.gov/news-events/press-releases/2019/04/geniux-dietary-supplement-sellers-barred-unsupported-cognitive, between August 2012 and January 2017, twelve corporate and four individual defendants deceptively marketed "cognitive improvement" supplements using sham news websites containing false and unsubstantiated efficacy claims, references to non-existent clinical studies, and fraudulent consumer and celebrity endorsements.
The FTC approved two separate settlement orders in this case.
The first order
https://www.ftc.gov/system/files/documents/cases/proposed_stip_j_and_order_gci_ds_4-10-19.pdfresolved the allegations against three individual defendants and ten corporate defendants.
The second order
https://www.ftc.gov/system/files/documents/cases/proposed_stip_j_and_order_phs_ds_4-10-19.pdfresolved the allegations against the remaining defendants. Both orders bar the defendants from making certain disease claims and several cognitive performance claims related to the covered products, including Xcel, EVO, Geniux, and Ion-Z, unless they have competent and reliable scientific evidence to support the claims when they are made.
The orders also imposed a combined $623,000 monetary judgment, which the FTC is using to provide refunds to defrauded consumers.
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===========================
Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312
Telephone: (919) 533-6009
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Consumer Health Digest
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