In the News for the Week of 1-9-07
- Drug trade group prohibits gifts to physicians
- Study finds quality-related compensation on the rise
- Medicare extends physician enrollment deadline to Feb. 14
- FDA working on additional labeling for rituximab
- Strengthened labeling proposed for OTC pain relievers
- Updated NIH guide gives clinicians new tools for patients with alcohol problems
- ACP Journal Club: Atorvastatin reduces stroke, CV events in patients with no known CHD
- Study finds intervention reduces catheter-related infections in ICUs
- Evidence finds post heart failure guidelines do not relate to early outcomes
- Medicare to pay for Part D vaccine administration in 2007
- Second Medicare provider satisfaction survey underway
- ACP Observer Web supplement: Managing the post-MI patient
- Entries sought for best adult immunization practices
The trade group that represents some of the world's largest drug manufacturers issued its first revised code of ethics in a decade, prohibiting its members from giving money or personal gifts to physicians.
The new code, issued Jan. 1 by the International Federation of Pharmaceutical Manufacturers & Assns. (IFPMA), allows for free drug samples but restricts any gifts to physicians to items that are medically useful and of small value. These might include relevant promotional aids or items of “modest value” that help in providing patient care, according to the code, which has been posted on the group's Web site.
Scientific conferences and meetings should be held in appropriate—not extravagant—locations, with hospitality limited to what physicians would normally pay for themselves. Companies shouldn’t pay any costs incurred by a physician’s guests, the code said.
The code applies to 26 direct member companies such as Merck & Co., GlaxoSmithKline, Pfizer and AstraZeneca, as well as the companies that belong to the IFPMA’s 46 member associations.
The federation also has a network of industry sources who will function as watchdogs, as well as a panel of compliance experts to field appeals and complaints, said the Jan. 4 Los Angeles Times. The article added that large pharmaceutical companies spend about one-third of their revenue on sales and marketing, which heavily target doctors.
The IFPMA code is online.
The Los Angeles Times is online.
Quality measurements are playing a larger role in physicians' compensation, according to a newly released study, but individual productivity is still the basis for most physicians' financial incentives.
The national study by the Center for Studying Health System Change found that compensation based partly on quality measures rose to 20.2% in 2004-05 compared with 17.6% in 2000-01, a statistically significant difference. However, about 70% of non-solo practice doctors reported financial incentives tied to individual productivity, a figure that has remained steady since 1996-97.
In a statement on its Web site, HSC researchers noted that the heavy reliance on productivity-based compensation is a reflection of the dominant fee-for-service payment system, which likely increases the overall cost of care.
Nearly all physicians with quality incentives also face productivity incentives, the study found. About 75% of those physicians viewed productivity incentives as a very important factor in determining their compensation, while 44% of doctors said that quality incentives were very important.
Quality-related compensation is more common among primary care physicians—particularly those treating adults—than specialists, the study found. It is also more common among doctors in large group practices than those in small or medium-sized practices. About 24% of doctors in non-solo practice don’t have their compensation tied to any explicit incentives, according to the survey, which included responses from more than 6,600 physicians.
The Center for Studying Health System Change issue brief is online.
Physicians now have until Feb. 14—an extra 45 days—to enroll as participating providers in the Medicare program for 2007.
Doctors typically must decide by Dec. 31 whether they want to enroll for the following year, but last-minute legislative changes to doctor reimbursements led to postponing the deadline this year, CMS said in a Dec. 22 background paper. The Tax Relief and Health Care Act of 2006, signed by the President on Dec. 20, halted an expected 5% cut by Medicare in physicians’ payments.
Physicians need only let their Medicare carrier or contractor know if they want to change their Medicare participation status. Any change in status made prior to Feb. 14 will be made retroactive to Jan. 1, 2007.
A provider participating with Medicare agrees to accept Medicare fees for services by filing a claim with the Medicare carrier. Medicare typically pays 80% of the services it allows directly to the physician, and the physician bills the patient for the remaining 20%, up to the Medicare “allowable amount.”
Non-participating physicians can still see Medicare patients, but different rules apply. They may bill the patient for as much as 115% of Medicare’s approved amount and Medicare reimburses the beneficiary directly. The physician is then responsible for collecting the entire approved amount from the beneficiary.
CMS is online.
The FDA has received reports of two patients who developed progressive multifocal leukoencephalopathy (PML), a fatal viral infection of the central nervous system, after taking the drug rituximab (Genentech's Rituxan) for systemic lupus erythematosus.
The FDA advised physicians to be alert to the risk of PML, especially since rituximab is often used off-label. Patients taking the drug should report any major changes in vision, balance or coordination to their doctor.
The FDA noted that PML has been reported in patients as late as 12 months after their last dose of rituximab. There have been 23 confirmed cases of PML in patients with lymphoid malignancies either during or after completion of treatment with the drug, said the FDA. The majority of these patients also had received other drugs known to affect the immune system. Additionally, cases of PML have occurred in patients who have not received rituximab.
The drug's label was last updated in February 2006 to include postmarketing reports of cases of serious viral illnesses, including PML, in patients being treated for lymphoma. The FDA is working with the drug manufacturer to add this recent information on PML to the drug label. Any serious adverse events possibly associated with the use of rituximab should be reported to FDA's MedWatch Adverse Event Reporting program online.
The FDA release is available online.
Rituxan manufacturer Genentech has posted information for healthcare providers online.
The Lupus Foundation of America also has posted updated information.
The FDA is proposing labeling changes to over-the-counter acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) to include safety information on the potential for stomach bleeding and liver damage, as well as when to contact a doctor.
The warnings would affect all internal analgesic, antipyretic and antirheumatic (IAAA) drug products, including aspirin, ibuprofen, naproxen and ketoprofen.
The FDA has proposed the following changes to product labels:
- warnings about the potential for liver toxicity, particularly when using high doses, when taking other products simultaneously or when taken with moderate amounts of alcohol.
- acetaminophen must be prominently identified on the product's principal display panel and outer carton (if applicable).
- highlight the potential for stomach bleeding in persons over age 60 and those who have had prior ulcers or bleeding or who take a blood thinner. Also includes those who take more than one NSAID, use it for longer periods than directed, or take it with moderate amounts of alcohol.
- the name of the NSAID ingredient and the term "NSAID" must be prominently identified on the product's container.
The new labeling would be required for all OTC drug products that contain an IAAA ingredient, whether alone or in combination with other ingredients, such as cold symptom relievers. Physicians should also alert patients that their prescription medications may contain IAAA ingredients.
Some manufacturers have already voluntarily added the safety information to their products.
The FDA release is online.
"Helping Patients Who Drink Too Much: A Clinician's Guide," produced by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is now available online.
The updated Guide includes a new medications management program that consists of brief, structured outpatient sessions designed for easy use in nonspecialty outpatient settings by physicians, nurses and other health care professionals.
In addition to the guide, clinicians can download screening instruments in English and Spanish, wallet cards, and an animated slide show that takes viewers step-by-step through the Guide's process for alcohol screening and brief intervention.
The NIAAA is offering the Guide's medication management approach to nonspecialty settings in order to expand access to effective treatment. Many patients with alcohol dependence either don't have access to specialty treatment or refuse referrals to specialists.
Other Guide updates include: a new handout with strategies to help patients cut down on drinking or quit, supporting resources for clinicians and patients; and information about a newly approved injectable drug to treat alcohol dependence.
The guide is online.
A recent trial found that atorvastatin reduced fatal or nonfatal stroke as well as seven secondary outcomes in patients with no known coronary heart disease and recent stroke or transient ischemic attack (TIA).
In the randomized controlled trial, researchers studied 4,731 patients who had ischemic or hemorrhagic stroke (69%) or TIA one to six months before randomization, were ambulatory, had a modified Rankin score < 3, and LDL cholesterol level 100 to 190 mg/dL (2.6 to 4.9 mmol/L). Patients received either 80 mg/day atorvastatin or placebo.
Patients in the atorvastatin group had a 2.2% absolute risk reduction in stroke and 3.5% absolute risk reduction in vascular events after five years compared with those who received placebo. The study is abstracted in the January/February ACP Journal Club.
The results indicate that statins modestly reduce the risk for both stroke and vascular events in patients with recent stroke without known CHD, said Journal Club reviewer Eric Cheng, ACP Member, of the Veterans Affairs Greater Los Angeles Healthcare System and University of California, Los Angeles. Patients taking statins did have a higher absolute risk for hemorrhagic stroke over the duration of the study, Dr. Cheng noted.
Along with antithrombotic and antihypertensive therapy, statins should be given to most patients with a recent cerebrovascular event to prevent further vascular events, Dr. Cheng concluded.
Peer ratings for this review: Internists, Neurologists: 6/7 stars. Primary Care Physicians, Geriatricians: 5/7 stars.
ACP Journal Club is online.
Five evidence-based interventions reduced rates of catheter-related bloodstream infection in ICUs by up to 66% over an 18-month period, a new study found.
The interventional cohort study involved 103 ICUs in 67 hospitals with more than 375,000 catheter-days of observation. Five strongly recommended CDC interventions were championed by local team leaders at the ICU: hand washing, using chlorhexidine for skin preparation, using full-barrier precautions during insertion of central venous catheters, using the subclavian vein as the preferred site of insertion of the catheter, and removing unnecessary central venous catheters. Clinicians were educated and reminded about the practices throughout the study period.
After three months, the median rate of catheter-related bloodstream infection per 1,000 catheter-days fell from 2.7 infections at baseline to 0, while the mean rate per 1,000 catheter-days decreased from 7.7 at baseline to 1.4 after 16-18 months, the study found. The study was published online Dec. 28 by the New England Journal of Medicine.
Randomized assignment of the intervention was not feasible, which reduces the ability to make causal connections between the intervention and catheter-related bloodstream infections, the authors noted. However, said an accompanying editorial, the costs and efforts to implement the five interventions are so relatively minor that they should be widely adopted.
Currently, central venous catheters may cause an estimated 80,000 catheter-related bloodstream infections and up to 28,000 deaths in ICU patients in the U.S. each year, the study’s authors said.
The New England Journal of Medicine abstract is online.
Of five published guidelines for treating patients after heart failure, only one—using ACE inhibitors and angiotensin receptor blockers—improved patient mortality and rehospitalization rates, according to a study published in the Jan. 3 Journal of the American Medical Association.
Numerous government agencies, health quality organizations and pay-for-performance measures rely on the five guidelines, which were developed by the American College of Cardiology and the American Heart Association. They are:
- written discharge instructions addressing activity, diet, medications, follow-up appointments and weight
- evaluation of left ventricular function
- ACE inhibitors or ARBs for left ventricular systolic dysfunction
- smoking cessation advice
- anticoagulants at discharge
Researchers prospectively collected 60- and 90-day post-discharge data from 5,791 patients at 91 U.S. hospitals between March 2003 and December 2004. They found that only ACE inhibitor/ARB use at discharge was associated with 60- to 90-day post-discharge mortality or rehospitalization. Also, beta-blockers, although not one of the ACC/AHA guidelines, were associated with the most significant improvements in heart failure patient outcomes.
The JAMA abstract is online.
Physicians can now be reimbursed for administering the new herpes zoster vaccine for older adults, as well as any other vaccines covered by a patient’s Medicare Part D plan, by using the newly created HCPCS code G0377.
The national payment for the code will be $19.44, which is based on the value assigned to CPT code 90471, immunization administration.
While the herpes zoster vaccine itself was covered by some Medicare Part D plans in 2006, there was no way for a physician to be paid for administering it. Under the Tax Relief and Health Care Act of 2006, however, Medicare is allowed to pay for the administration of any vaccines that are covered under Medicare Part D.
It is likely that coding for Part D vaccine administration will change again in 2008, due to requirements of the law.
CMS is online.
CMS is conducting its second annual provider satisfaction survey of Medicare fee-for-service contractors who process and pay more than $280 billion in Medicare claims each year, the agency said last week.
The survey was sent to 35,000 randomly-selected Medicare providers, including physicians, during the first week of January. It focuses on seven major parts of the provider-contractor relationship: communications, inquiries, enrollment, claims processing, appeals, medical review, and audit and reimbursement. It is designed to be completed in about 15 minutes, and responses can be submitted via a secure Web site, mail, fax or by phone.
CMS is asking providers to respond by February and survey results are expected to be available in July. Results from the first survey, released in September 2006, showed that the majority of Medicare health care providers were satisfied with the customer service, claims processing and educational activities provided by contractors.
Information about the survey will be disseminated to providers through a variety of channels, including Open Door Forum conference calls and Medicare Learning Network (MLN) Matters articles posted on the CMS Web site throughout the survey process.
Further information is online.
Members can now go online to access ACP Observer's latest Web-based supplement, on post- myocardial infarction. This special issue guides physicians through the process of caring for post-MI patients, from evaluation and management to the most current evidence-based treatment options and appropriate follow-up care.
The primary care physician plays a crucial role in guiding patients through the MI recovery period and reinforcing the message that targeted prescription regimens and lifestyle changes can greatly reduce the risk of recurrence. The supplement is online.
The Morehouse School of Medicine is seeking entries for its Best Practices in Eliminating Adult Immunization Disparities contest.
Adult immunization rates have not risen as high as childhood immunization rates, and there are significant disparities in adult immunization rates based on race, ethnicity, poverty and insurance.
Contest organizers seek models for best practices in reducing these disparities in adult influenza and pneumococcal vaccinations to create a toolkit resource guide based on the winning model. Each entry should be from an adult immunization program or initiative that is currently running or recently completed. The practice should be adaptable to other organizations and must have specific, measurable results.
Submissions are due Jan. 19. The winning organization will receive $1,000 in gift cards, and two runners-up will receive $500 apiece in gift cards.
Contest entry information is available online.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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