Consumer Health Digest #16-13
Your Weekly Update of News and Reviews
April 10, 2016
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It 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.
Another study pans long-term antibiotic therapy for "chronic Lyme disease." Another study has confirmed the futility of long-term antibiotic therapy for people with symptoms attributed to "chronic Lyme disease." This study involved 252 patients who received 2 weeks of standard antibiotic treatment followed by 12 weeks in which they received either doxycycline, another antibiotic, or a placebo. The three groups demonstrated no significant differences in outcome. [Berende A and others. Randomized trial of longer-term therapy for symptoms attributed to Lyme disease. New England Journal of Medicine 374:1209-1220 2016] An accompanying editorial concluded: "Patients with subjective, vexing symptoms attributed to Lyme disease should not anticipate that even longer courses of antibiotics will produce relief, a finding that is in concert with results from previous trials." [Melia TM, Auwaerter PG. Time for a different approach to Lyme disease and long-term symptoms. New England Journal of Medicine 374:1277-1278, 2016]
Another "Lyme literate" doctor disciplined. Despite the lack of evidence that long-term antibiotic therapy is useful against real or suspected Lyme disease, a small network of physicians who are commonly referred to as "Lyme literate" still administer it. Licensing boards generally frown on this practice but are unlikely to act without notification that a problem may exist. In 2015, the Maryland State Board of Physicians charged Daniel A. Jaller, M.D. with failing to meet the standard of care in his management of six patients whom he had treated for Lyme disease, bartoneliosis, and/or babesiosis without adequate evidence that they had these conditions. The statement of charges indicates that in 2013, the board was notified that Jaller had surrendered participation in an insurance program while being investigated for inappropriately treating patients. The board's investigation concluded:
- Jaller's diagnoses were based on negative or indeterminate blood tests and, in some cases, without objective evidence of infection (such as tick bites) in the patient's history.
- Jaller diagnosed multiple chronic infections based mostly on subjective symptoms likely attributable to other diagnoses and consistently failed to consider alternative diagnoses.
- Jaller failed to refer patients to specialists to address severe symptoms of depression, neuropathy and/or chronic fatigue that he had documented.
- Based on his diagnoses of bacterial infections, Jaller prescribed antimicrobial treatment for months and often years, using as many as seven agents at a time and exposing patients to undue risks of complications of central venous catheter usage, adverse drug reactions, and increased resistance to the drugs.
The charges were settled with a consent order under which Jaller was reprimanded, ordered to take a course in medical documentation, and placed on probation for one year, during which he may be subject to chart and/or peer review.
Acupuncture judged ineffective against back pain. The National Institute for Health and Care Excellence (NICE) has concluded that acupuncture is no better than a placebo in treating low back pain and sciatica. Its draft guidance report also said that enough studies had been done to conclude that further research is unlikely to alter this conclusions. NICE's 2009 guideline had recommended considering up to 10 sessions of acupuncture needling over a period of up to 12 weeks. [Davis N. Acupuncture for low back pain no longer recommended for NHS patients. The Guardian, March 24, 2016]
Chiropractor gets prison sentence for "custom orthotics" fraud. Donald Havey, D.C., has been sentenced to 51 months in prison and ordered to pay restitution of $2,276,221 related to a scheme to bill for expensive custom ankle-foot orthotics that were not actually provided to the patients. The criminal information and a sentencing memo in the case indicate:
- From 2009 to 2014, Havey defrauded Medicare, Medicaid, other insurance companies, and patients by submitting false claims for custom orthotic boots for which he collected between $2,200 and $2,400 per pair. The boots that were actually provided did not contain the features described in the claims and should have been sold for about $200.
- Havey recruited chiropractors in twelve states and gave them specific written instructions on how to market themselves to nursing home staff and patients. Among other things, he said to target Medicare patients, promote the program as a fall prevention program, and conceal the fact that the program's true purpose was to sell the boots. Havey also tricked patients and their families into believing that there would be no cost to them, when he knew the co-payment might be as much as $500.
- Many nursing home staff members reported that the boots did not reduce falls, actually increased falls, caused chafing and tears of the skin, were difficult for many patients to wear, and were generally not worn. Relatives stated they would not have consented had they known how much Medicare was paying for the shoes and the amount of their co-payment.
- Knowing that Medicare would scrutinize any company that submitted many claims for very expensive boots, Havey attempted to conceal the volume by creating five companies through which he billed.
In January, Havey's billing assistant, Susan Reno, was sentenced to five years of probation and ordered to pay restitution of $10,571. [Local chiropractor and billing assistant sentenced on health care fraud charges. U.S. Department of Justice press release, March 2, 2016]
This page was posted on April 10, 2016.