Thursday, September 21, 2023
Senate Nixes 1099 Requirement
The Senate voted in April to eliminate an onerous tax-reporting duty in the new healthcare reform law. The Affordable Care Act (ACA) requires all businesses, beginning in 2012, to file federal tax form 1099 if they buy $600 or more worth of goods or services in a given year from any vendor. A medical practice would have had to file the form for a $600 printer from Office Depot, for example. The business community, as well as organized medicine, had vehemently objected to the new requirement, saying it would cost them too much in time and money.
Healthcare Reform Goes to Court
Although a slower year for healthcare reform than 2010, when the landmark ACA legislation was passed, 2011 has seen a variety of judicial decisions as lawsuits against it have moved through the courts. In January, a federal judge in Florida struck down the entire ACA because it requires individuals to buy health insurance or else pay a penalty, a provision the judge ruled both unconstitutional and inseparable from the rest of the law. More federal courts, though, have upheld the law than struck it down. The judicial disagreement led ultimately to the Supreme Court in November deciding to take up the issue. One state decided to take matters in its own hands. In May, Vermont voted to create a publicly financed universal healthcare system.
Medicare Pay Cut
Physicians know the holidays have arrived when Congress makes its usual last-minute, December stab at averting a giant cut in Medicare reimbursement on January 1. Medicare's sustainable growth rate (SGR) formula has triggered these reductions each year since 2002, but only that year's cut took effect — Congress has delayed all the others. Every postponement makes the next cut even deeper. In 2012, physicians face a 27.4% reduction, which could drive many out of the Medicare program. Organized medicine wants the SGR repealed, but it probably will have to settle for another short-term postponement — a dubious holiday gift from lawmakers.
FDA Drug Warnings
A variety of drug warnings made news in 2011: The FDA recommended in June that physicians should refrain from using the 80-mg dose of simvastatin unless the patient has already been taking the drug for 12 months and there is no evidence of myopathy. Also in June the FDA warned of an increased risk of being diagnosed with a high-grade prostate cancer while taking 5-alpha reductase inhibitors. In July the FDA warned that clinicians generally should avoid prescribing either methylene blue or linezolid in combination with serotonergic agents to avoid a potential drug interaction causing serotonin syndrome. And in August, the FDA said the antidepressant citalopram should not be used in doses higher than 40 mg per day because of concerns that it can cause potentially fatal changes in heart rhythm.
Ban on Prescription Data Mining Overturned
The US Supreme Court in June overturned a Vermont law that banned the use of physician prescription drug records for marketing purposes, ruling for free-speech rights over medical privacy concerns. The nation's high court struck down a 2007 law that prohibited the practice of data mining: the sale, transmission, or use of prescriber-identifiable information for marketing a prescription drug without the prescribing physician's consent. Data-mining companies that collect and sell such information — IMS Health, Verispan, and Source Healthcare Analytics — had challenged the law.
Cell Phones and Potential Cancer Risks
Use of a cell phone for as little as 50 minutes at a time appears to affect brain glucose metabolism in the region closest to the phone's antenna, a study released in February showed. And in May the World Health Organization (WHO) announced that radiation from cell phones can possibly cause cancer. This announcement was based on an extensive review of studies on cell phone safety by a working group of 31 scientists from 14 countries. However, in July a study found that children and adolescents who use cell phones do not appear to be at a higher risk for brain cancer, further adding to the debate.
Good Riddance to Propoxyphene
In the wake of the market withdrawal of propoxyphene in November 2010, prescribers this year had to decide which analgesics were the best alternatives to the "worst drug in history."
Updated Influenza Vaccine Recommendations
The CDC's updated guidance for influenza vaccination in the United States for the upcoming 2011-2012 flu season held few surprises, resulting in the CDC's decision to publish it in a shortened format in August. The new guidelines include recommendations for people with egg allergy, and the updated recommendations make note of the new intradermally administered trivalent inactivated vaccine preparation (Fluzone Intradermal, Sanofi Pasteur) licensed in May 2011.
New Top Hospital Rankings
Top hospital rankings are hugely popular with physicians and other healthcare professionals, allowing them to see whether and where their institutions appear in the lists. In January, HealthGrades released its first-ever ranking of the nation's top 50 hospitals based on a comprehensive study of patient mortality and complication rates at nearly 5000 hospitals. And in March, US News & World Report released its first-ever ranking of hospitals within 52 metropolitan areas.
AIM-HIGH Fell Down
In May, a trial of niacin to improve triglyceride and HDL levels was halted prematurely, 18 months ahead of schedule, because it showed no benefit. In the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL Cholesterol/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) trial, high-dose extended-release niacin (Niaspan, Abbott) was given in addition to statin therapy in patients with a history of cardiovascular disease, high triglycerides, and low levels of HDL cholesterol. There was also a small, unexplained increase in ischemic stroke in the niacin group. However, later results suggested the stroke finding was due to chance, and some experts blasted the study as being far too short and underpowered to change practice.
'Very, Very Important Paper' on Prostate Cancer Surveillance
Radical prostatectomy appears to be a wise choice for men with early-stage prostate cancer who are younger than 65 years, according to new data from a Swedish randomized clinical trial that compared surgery with "watchful waiting." The study, published May 5 in the New England Journal of Medicine, showed that, at 15 years, the cumulative incidence of death from prostate cancer was 14.6% among 347 men randomized to prostatectomy vs 20.7% among 348 men being observed without treatment. However, the survival benefit was confined to men younger than 65 years of age.
Vitamin Supplements Linked to Increased Risk for Death
In women aged 55 to 69 years, several widely used dietary vitamin and mineral supplements, especially supplemental iron, may be associated with increased risk for death, according to new findings from the Iowa Women's Health Study. Although many vitamin supplements did not appear to be associated with a higher risk for total mortality, several were, including multivitamins, vitamins B6, and folic acid, as well as the minerals iron, magnesium, zinc, and copper. The findings were reported in the October 10 issue of the Archives of Internal Medicine.
Donald Berwick Resigns as Head of CMS
On November 23, Donald Berwick, MD, announced his resignation as administrator of the Centers for Medicare and Medicaid Services (CMS), effective December 2, after a tumultuous term of only 17 months. In July 2010, President Barack Obama installed Dr. Berwick as CMS administrator through a "pocket" appointment while the Senate was in recess. The special appointment would have expired by law at the end of 2011. Dr. Berwick was renominated in January 2011, but he faced granite opposition from Senate Republicans, who viewed the patient-safety advocate as Obama' s point-person for socialized medicine. His resignation, therefore, came as no surprise.
MMR- Autism Vaccine Study an 'Elaborate Fraud'
In January, the BMJ published a series of 3 articles and editorials charging that the study published in the Lancet in 1998 by Andrew Wakefield (pictured above) and colleagues linking the childhood measles-mumps-rubella (MMR) vaccine to a "new syndrome" of regressive autism and bowel disease was not just bad science but "an elaborate fraud."
Wakefield was planning to market a diagnostic testing kit with expected yearly sales of 28 million pounds (US $43 million) as well as immunotherapeutics and a "safer single measles shot," for which he held a patent. And finally, the third article in the series claimed, the medical establishment "closed ranks" to protect Wakefield.
'Bath Salt' Street Drugs Temporarily Banned
The US Drug Enforcement Administration (DEA) in October temporarily banned 3 synthetic stimulants marketed as "bath salts" and "plant food" that mimic cocaine, LSD, MDMA, and/or methamphetamine when ingested. The move followed a September 8 letter to the editor in the New England Journal of Medicine reporting that people who overdose on the bath salts are showing up in emergency departments with increasing frequency.
Natural Disasters in 2011
The devastating magnitude 9.0 earthquake and tsunami that occurred in Japan's Miyagi prefecture on March 11 caused a cascade of health and safety problems for survivors, including exposure to radiation from the region's damaged Fukushima Daiichi nuclear plant. The disaster strained medical resources on the ground and potential adverse effects are ongoing even now, with recent reports of radioactive water possibly leaking into the Pacific Ocean.
In comparison, the health effects of Hurricane Irene in August were relatively mild, although hospitals and clinicians still had to prepare for the worst.
Medicine and Politics
GOP presidential candidate and US Representative Michele Bachmann (R-MN) made medical news twice this year. On the Today Show in September, Bachmann said that after the recent Republican presidential candidate debate in Tampa, Florida, a woman said that her daughter received the human papillomavirus (HPV) vaccine and developed "mental retardation" thereafter. Two bioethicists then challenged Bachmann to provide proof that HPV vaccination causes mental retardation and offered money for the evidence. And back in July, discussion of Bachmann's migraines stirred debate about whether migraines could hinder one's ability to lead the country.
First New Lupus Drug in 50 Years
The FDA approved belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline), the first new treatment for systemic lupus erythematosus in a half-century, in March. It was approved in Europe in July. One expert suggested that it should mainly be used in patients with moderately severe disease; mild disease is relatively well controlled with nonsteroidal anti-inflammatory drugs, short courses of steroids, and antimalarial drugs.
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