In the News for the Week of 10-24-06
- DPP-4 inhibitor approved for type 2 diabetes treatment
- CMS introduces P4P demo for small practices
- Alert warns of counterfeit glucose test strips
- Survey ranks medical boards’ public information
- ACP Journal Club: Prompt revascularization improves survival after STEMI and cardiogenic shock
- Mid-career health policy fellowships available
- North Carolina man pleads guilty to hacking into ACP database
- New ambulatory EMR report offered
- ACP and CMS Web sites answer Medicare Part D questions
- ACP President supports bill to expand ranks of primary care physicians
- ACP President praises legislation to broaden health insurance coverage
- ACP Governor advising Japanese cabinet
Federal regulators last week approved the first DPP-4 inhibitor for treatment of type 2 diabetes. Sitagliptin phosphate (Merck's Januvia) is a once-daily pill for use by itself or in conjunction with metformin or a peroxisome proliferator-activated receptor gamma agonist.
The drug was approved following clinical trials involving 2,719 patients with type 2 diabetes that lasted from 12 weeks to more than a year, said the FDA. The trials found improved blood sugar control when the medication was used alone or in patients who were not satisfactorily managed with metformin or a PPAR agonist. The most common side effects were upper respiratory tract infection, sore throat and diarrhea.
The pills will cost just under $5 a piece, or about $145 a month, according to Merck officials quoted in the Oct. 18 New York Times. The company expects to begin shipping samples and marketing the drug to doctors and patients almost immediately.
FDA approval is also expected later this year for Novartis’s new DPP-4 inhibitor, vildagliptin (Galvus). Together the new drugs are expected to rapidly replace sulfonylureas because of their reduced risk of weight gain and hypoglycemia, said the New York Times.
The FDA release is online.
The New York Times is online.
CMS has announced a new pay-for-performance demonstration aimed at small- to medium-size group practices that care for Medicare beneficiaries with chronic conditions.
The three-year Medicare Care Management Performance (MCMP) demonstration will be implemented next year in Arkansas, California, Massachusetts and Utah, the same states that served as pilots for CMS’ Doctor’s Office Quality-Information Technology project (DOQ-IT). Approximately 800 practices in the four states will take part in the new demonstration.
According to the MCMP project director, there may be slots available for practices not currently participating in the DOQ-IT program. Interested physicians in the participating states, who are willing to work to implement health information technology, care coordination and data reporting features in their practices, should immediately contact their local QIO. In order to participate, physicians must be the main primary care provider for at least 50 fee-for-service Medicare beneficiaries in a medium-sized or smaller practice. Recruiting is scheduled to continue through the early spring, and the demonstration should “kick off” by summer.
In its first year, the program will be a pay-for-reporting initiative to provide baseline information on quality and to help physicians become familiar with the quality measurement process. Participants will submit data on quality measures related to the treatment of diabetes, congestive heart failure and coronary artery disease, as well as the provision of preventive health services. In subsequent years, based on their performance on the quality measures, practices will be eligible to earn an annual incentive of up to $10,000 per physician and $50,000 per practice.
The demonstration is expected to result in Medicare savings by reducing hospital and emergency room admissions and delaying or avoiding complications from chronic illness, CMS officials said in a press release. The success of the program will be determined by an independent evaluation funded by CMS and the Agency for Healthcare Research and Quality.
More information is online.
The FDA has issued a nationwide alert about counterfeit OneTouch Brand Diabetes Test Strips. The counterfeit product and packaging mimic the appearance of genuine blood glucose strips intended for distribution outside of the United States.
LifeScan, Inc., the manufacturer of the strips, recently alerted the FDA to the existence of the counterfeits, which were distributed to stores nationwide, but primarily in Ohio, New York, Florida, Maryland and Missouri. Performance testing of the counterfeit test strips found erratic results that do not meet the manufacturer’s performance specifications. The counterfeits were sold in 50-count packages, labeled as OneTouch (Basic/Profile) and OneTouch Ultra Test Strips. The packaging contains multiple languages, including English, Greek, Portuguese and French. The affected lot numbers are 272894A, 2619932, 2606340, and 2691191.
Consumers of the test strips are advised to check their supplies. If any packages match the counterfeits’ description, the discovery should be reported immediately to LifeScan at 866-247-0264. Patients who have used the counterfeit strips are also advised to discontinue use, obtain replacements and contact a physician. Any adverse reactions or quality problems should be reported to the FDA’s MedWatch Program and health care professionals were asked to inform their diabetic patients about the alert.
More information from the manufacturer is online.
A new survey of the information provided by state medical board Web sites ranked New Jersey’s site as the best of the 50 states and North Dakota as the worst. The report, released by consumer advocacy group Public Citizen, evaluated the content and user-friendliness of online information about physician disciplinary action.
All of the states provide some physician information online, but the quantity of information ranges widely from simply a name and address to detailed explanations of disciplinary actions and malpractice payouts, said the Oct. 18 New York Times. The survey found that very few states provide information on disciplinary actions other than those taken by the medical boards themselves. Five states provide no disciplinary information, and an additional eight states do not allow users to search for disciplinary actions.
After New Jersey, the highest-ranked websites were in Virginia, New York, Vermont and Massachusetts, which in 1996 became the first state to require its medical board to post disciplinary actions online.
Sites were ranked on several different factors including:
- types of physician-identifying information
- disciplinary action taken by the medical board
- disciplinary actions taken by hospitals
- disciplinary actions taken by the federal government
- malpractice information
- criminal conviction information
The report offered suggestions for improving the sites, such as frequent updates and detailed descriptions of all actions taken by the medical boards. It also suggested that state legislatures require the boards to obtain and post criminal, malpractice, hospital and federal disciplinary information on all physicians.
The full report is online.
The New York Times is online.
A recent trial of more than 300 patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS) confirmed that an early invasive strategy improves long-term survival.
In the randomized controlled trial, 302 patients with STEMI who developed CS due to left ventricular failure received early revascularization (within six hours) with either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery, or initial medical stabilization involving thrombolysis, intraortic balloon counterpulsation and revascularization 54 or more hours after randomization.
Patients who received early revascularization had three- and six-year mortality rates of 72% and 80%, respectively, compared with 59% and 67% for patients receiving initial medical stabilization, a relative risk reduction of 17%-19%, and a number needed to treat of 8. The study is abstracted in the November-December ACP Journal Club.
CS complicates acute STEMI in about 8% of patients and is associated with hospital mortality rates of 50% at hospitals with early revascularization capabilities and 80% mortality at hospitals without such capabilities, said Journal Club reviewer Eric R. Bates, FACP, of the University of Michigan in Ann Arbor, Mich. Only revascularization with PCI or CABG surgery and reperfusion of ischemic myocardium have been shown to decrease mortality.
Even with coronary revascularization, other interventions are needed, said Dr. Bates. For example, tilarginine acetate, an agent that inhibits nitric oxide production and helps restore regulation of vascular tone and cardiac contraction, is now being tested in a randomized controlled trial.
ACP Journal Club is online.
The Robert Wood Johnson Foundation is currently accepting applications for its Health Policy Fellowship Program in Washington, D.C. The fellowship provides an opportunity for mid-career health professionals and behavioral and social scientists with an interest in health to experience and participate in the health policy processes at the federal level. Past fellows have used the experience to provide leadership to improve health, health care and health policy at the national, state or local level.
Candidates from academic faculties and nonprofit health care organizations are encouraged to apply. Applicants may have backgrounds in many disciplines, including medicine, public health and health administration. A maximum of 10 fellows will be selected for the program and awarded up to $84,000 for one-year in Washington, D.C. Fellows are able to continue their health policy activities for up to two years after the Washington placement period through pre-approved leadership development activities.
The goal of the fellowship is to prepare individuals to influence the future of health care and accelerate their own career development. Applicants must be citizens or permanent residents of the U.S. and sponsored by an organization or institution. They will be selected based on their achievements, skills and potential for growth and leadership. The deadline for applications is Nov. 17, 2006.
Application information is online.
A businessman who markets databases on doctors and other professionals was convicted after pleading guilty last week to charges that he illegally downloaded physician information from the College’s web site.
William A. Bailey Jr., of Charlotte, N.C., used accounts of legitimate members to access the ACP database between January and May 2005 for “commercial advantage and for private financial gain,” according to the May indictment. Mr. Bailey pleaded guilty on Oct. 13, 2006 to charges of gaining unauthorized access to the database. ACP earlier settled a civil case against Bailey and was awarded damages.
John Mitas, FACP, ACP's chief operating officer, said authorities were able to pinpoint Mr. Bailey after the College notified the FBI about unusual activity tracked on the College's Web site. Dr. Mitas said the College continues to monitor Web security and, since the indictment, both the Member Connection and registration process have been re-launched with additional security features.
“The security of our members is critically important to us,” said Dr. Mitas. “We keep a vigilant watch over Web-site activity, which is why we were able to spot Mr. Bailey. Members should know that we will take every safeguard necessary to ensure the protection of their information.”
Sentencing is scheduled for Jan. 6, 2007.
Which ambulatory electronic health record (EMR) has the highest customer satisfaction? How does an EMR affect physician work flow? How easy is it to customize templates for specialties? How much does an EMR cost? How does an EMR really benefit a small physician practice?
The answers to these questions and more can be found in the “Ambulatory EMR" (1 - 5 physicians) report, written by KLAS Enterprises. The report, which summarizes the feedback received from over 850 physician sites, helps clinicians, administrators and information technology executives distinguish among the vendors in the ambulatory EMR marketplace.
ACP members can gain access to the free “Ambulatory EMR” report and the KLAS database after completing a KLAS online survey about the health information systems currently used in their practices. The KLAS database contains anonymous feedback from over 6,000 healthcare facilities to aid practices in the EMR selection process.
More information is online.
As open enrollment for Medicare Part D nears, the College’s Part D Web site can help physicians better understand the plan options and answer patients’ questions.
The site offers basic, practical information on the Part D benefit for physicians and staff. In addition to College-produced information, it has links to useful CMS forms and documents as well as patient-oriented materials. New additions to the site include an updated short course on the benefit and an FAQ specifically focused on changes for 2007.
CMS also recently updated its Medicare Prescription Drug Plan Finder Web tool, whichh now includes a Monthly Cost Estimator—a personalized chart projecting12 months of expected drug spending for each plan. New features help users compare plans based on price and benefit structure, estimate how their monthly costs may vary over the course of the year, and print clear reports they can refer to later.
With the plan finder, beneficiaries can focus on the plan features that they find most important, such as premiums, formularies or supplemental coverage during the gap in Part D coverage. The tool can sort plans based on estimated annual costs, or narrow the search based on the particular features that consumers find most important, such as premiums, formularies or copays. Open enrollment for the 2007 Part D program begins Nov. 15 and continues until Dec. 31.
ACP's Part D information is online.
The Medicare plan finder is online.
ACP President Lynne M. Kirk, FACP, expressed the College's support for the U.S. Physician Shortage Elimination Act, introduced in the House by Rep. John Conyers Jr. (D-Mich.).
The bill is designed to increase the number of physicians in the areas of primary care, psychiatric care and emergency medicine in federally designated physician shortage areas. The legislation contains several different approaches, including:
- creating of a National Health Service Corps Medical School Scholarship Program;
- giving grants to medical schools to increase their capacity to accept students, develop curriculum, and recruit, train and retain faculty; and
- funding grants to community health centers to increase primary care capabilities through the construction, expansion or renovation of facilities.
The number of medical students and residents choosing to pursue careers in general internal medicine is declining at an alarming rate, said Dr. Kirk in a letter to Rep. Conyers. Any shortage of internists and other primary care physicians will only aggravate the existing crises in health care, she added, because these physicians are critical to coordinating the care of older adults and patients with chronic conditions.
The full text of Dr. Kirk’s letter is online.
In an Oct. 16 letter, ACP President Lynne M. Kirk, FACP thanked Reps. Tammy Baldwin (D-Wisc.) and Tom Price (R-N.M.), for introducing the Health Partnership through Creative Federalism Act.
The bill is designed to promote innovation through state-based initiatives that expand health care coverage. Individual states submit proposals for expanding health care coverage and access in their state. The proposals are reviewed by a committee and then submitted to Congress for approval.
Encouraging innovation through state initiatives can help us move toward better health care, said Dr. Kirk. The Health Partnership through Creative Federalism Act offers the nation an opportunity to institute innovative programs while controlling health care costs and maintaining a safety net of standardized minimum benefits, she added.
The full text of Dr. Kirk’s letter is online.
Kiyoshi Kurokawa, MACP, was appointed Science Advisor to the Prime Minister of Japan and his cabinet on Oct. 3. Dr. Kurokawa has been Governor for the Japan Chapter since its founding in 2003.
Dr. Kurokawa is also president of the Science Council of Japan and a member of the Committee of Science and Technology Policy of the Cabinet Office of the Government of Japan. He is a professor emeritus at the University of Tokyo and commissioner of the World Health Organization Commission for Social Determinants of Health.
Dr. Kurokawa is well known in his professional community, both nationally and internationally, as a leader and advocate for many academic and professional activities in Japan. He received the Order of Purple from the Government of Japan for Excellence in Academic Achievements in 1999.
More information about ACP Japan is online.
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Copyright 2006 by the American College of Physicians.
A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?
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