In the News for the Week of 6-29-04
- CMS project will offer early chronic disease drug benefit
- Medicare ups pressure for HIPAA compliance after July 1
- House defeats bill with health care spending restrictions
- Study finds gap in subspecialty care for poor and uninsured
- Free toolkit focuses on preventing heart disease in women
Clinical news in the headlines
- Cancer, not chemotherapy, may cause some "chemobrain" symptoms
- Women with hysterectomies getting unnecessary Pap tests
- Number of cancer survivors rising steadily
- Experts debate how aggressively to treat DCIS
- Highlights of ACP Journal Club
- College calls for changes in Stark II interim rule
- ACP backs bill to improve geriatric chronic care
- College makes recommendations for CMS' chronic care pilot
Up to 50,000 seniors with serious and chronic diseases will participate this year in a new Medicare demonstration project, which will run through 2005. Designed to cover self-administered medications, the project will provide drug coverage for selected beneficiaries more than one year before the full Medicare drug benefit takes effect.
Mandated as part of last year's Medicare reform, the Medicare demonstration project will be open to seniors with diseases such as cancer, multiple sclerosis and rheumatoid arthritis. If more than 50,000 beneficiaries apply, Medicare will select participants through a lottery that will include both cancer and non-cancer patients, according to a June 24 HHS press release. The government has set aside $500 million to pay for the project, with up to 40% of funds slated to cover oral anti-cancer medications.
The project is designed to cover drugs self-administered by patients, replacing medications currently administered in a physician's office. Participants' co-pays will be the same as the standard Part D drug benefit slated to take effect in 2006, with special provisions available for low-income participants.
To participate, beneficiaries must be enrolled in Medicare Part A and Part B and have Medicare as their primary payer, In addition, patients may not have other comprehensive drug coverage to be eligible. Patients must also have signed authorization from their physician.
The CMS will be giving information to physicians, patient advocacy groups and drug manufacturers to help them assist beneficiaries applying for the project. Applications will be accepted through Sept. 30, but those who apply by Aug. 16 will be in an early selection process that could provide coverage by Sept. 1.
More information is available by calling CMS customer service at 1-866-563-5386.
The HHS press release is online.
A project application is available on the CMS Web site.
On July 1, the CME intends to begin delaying payments on non-HIPAA compliant electronic claims.
After that date, physicians who file non-compliant claims, as well as physicians who submit paper claims, will have to wait 27 days for payment. Physicians submitting compliant electronic claims will be paid in 13 days.
CMS' intent is to put added pressure on providers to ensure that they, or their billing agency or clearinghouse, are HIPAA compliant.
The HIPAA transactions rule implementation deadline was October 16, 2003. The CMS and many payers, however, created contingency plans to allow extra time for providers who were making a good faith effort to comply.
As of June 11, more than 87% of claims received by Medicare were HIPAA compliant. Eventually, however, CMS--as well as private payers--will stop paying non-compliant claims.
According to CMS requirements, all claims submitted electronically must comply with the HIPAA transactions rule national standards, and all practices with more than 10 employees must submit claims electronically.
The House of Representatives last week defeated a budget reform proposal that would have cut funds for medical training and research and capped spending on Medicare, Medicaid and other health programs.
The College was part of a coalition that strongly opposed the proposal. The coalition, which consisted of 18 other medical, academic, trade and advocacy associations, expressed that opposition in letters sent earlier this month to House members.
In a press release, ACP pointed out that the proposed budget reform would have forced significant cuts in domestic health programs. The proposal also included a "pay as you go" measure that would have mandated offsetting any increases in Medicare or Medicaid spending with funding cuts within those same programs.
The coalition also opposed provisions in the bill that would have restricted funding for emerging medical technologies and coordination of care methods.
The College press release is online.
While access to primary care has improved for some low-income and uninsured patients, many patients face serious problems getting subspecialty care, as well as mental health and dental services.
Those findings were part of a study released this month by the nonpartisan Center for Studying Health System Change (HSC), which drew on visits to 12 U.S. metropolitan areas in 2002-03. In the communities studied, subspecialists limited the number of patients they treated who were uninsured or covered by Medicaid or SCHIP.
Low Medicaid and SCHIP payments rates were identified as a major factor in that restriction. Other problems included state cutbacks in Medicaid funding and growing demand triggered by increased immigration and unemployment.
In several communities, primary care had improved due to a growing number of community clinics. But primary care clinics reported major difficulties in referring patients for five different subspecialty services, including gastroenterology, cardiology and endocrinology, as well as orthopedics and dermatology.
The study's authors noted that charity care pools created by cities and states to treat low-income patients are typically designed to pay hospitals, not individual physicians or medical groups. Strategies to solve these problems include expanding community clinics and creating financial and other incentives--such as liability protection--to attract volunteer physicians.
The HSC press release is online.
The complete "Health Care Access for Low-Income People: Significant Safety Net Gaps Remain" report is online.
As part of its "Go Red for Women" campaign, the American Heart Association (AHA) is offering ACP members a free "toolkit" of materials to help implement new AHA guidelines on preventing heart disease in women.
The kit includes a digest version of the new AHA treatment guidelines, personalized appointment reminder cards, four educational posters, 50 copies of a patient education brochure on women and heart disease, and instructions on how to access a PDF patient tracking file and download the new guidelines to a handheld computer.
Toolkit quantities are limited. Order the toolkit by phone at 800-203-8607 or online.
Clinical news in the headlines
Some of the cognitive problems experienced by cancer patients undergoing chemotherapy may be caused by the disease, not the treatment.
A new study, published last week in the online edition of Cancer, assessed 84 breast cancer patients before and after chemotherapy. Researchers found that 35% of those patients had significant cognitive impairment before treatment, higher than what would be expected in the general population. After chemotherapy, 61% of patients experienced cognitive problems, with about half recovering within a year.
While the study does not establish whether cancer causes impairment, it was the first to discover cognitive problems in patients prior to chemotherapy, according to the June 21 Associated Press. Doctors had previously assumed that all cognitive impairment was caused by drug treatment.
The findings are important, authors said, because some patients are reluctant to undergo chemotherapy because they fear developing "chemobrain" and other side effects, the Associated Press said. The findings also underscore the importance of doing pre-chemotherapy baseline neurological assessments to see if treatment impairs cognitive function.
The Cancer abstract is online.
The Associated Press is online.
A new study has found that up to 10 million women who had their cervix removed during hysterectomies are still getting Pap tests, confounding the problem of false positives and wasting health care dollars.
The 10 million women make up about 12% of the 85 million women currently being screened for cervical cancer, said the author of a study in the June 23 Journal of the American Medical Association. The study analyzed national data over 10 years.
The unnecessary testing stems from engrained habit on the part of physicians, as well as from patients' expectations that they will continue to be screened, according to the June 23 New York Times. Experts speculated that physicians are reluctant to advise against the relatively cheap and easy procedure because of fears over possible liability if patients turn out to have vaginal cancer.
In fact, the New York Times reported, vaginal cancer is very rare, and testing vaginal cells is more likely to result in false positives. As a result, women may end up having biopsies and removal of vaginal tissue when no cancer is present.
The JAMA study also found that the proportion of women with hysterectomies having Pap tests stayed at 68% from 1992-2002, even though no professional group recommends testing women without a cervix.
The JAMA abstract is online.
The New York Times is online.
A new report has found that the number of cancer survivors in the United States has increased significantly over the last three years and should continue to rise due to improvements in cancer detection, treatment and care.
According to the report, 64% of adults whose cancer is diagnosed today can expect to be living in five years, while more than 60% of cancer survivors are age 65 and older. The report was compiled by the National Cancer Institute and the CDC.
According to the report, breast cancer survivors make up the largest group among survivors (22%), followed by patients surviving prostate cancer (17%) and colorectal cancer (11%).
The findings, published in the CDC's June 25 Morbidity and Mortality Weekly Report, have important health care implications, according to a CDC press release. Previously, public health programs concentrated on early detection and cancer prevention.
Now, however, more programs must focus on cancer survivorship, while guidelines for follow-up and health promotion need to be developed.
The MWMR is online.
The CDC press release is online.
Amid a nearly tenfold increase of ductal carcinoma in situ (DCIS) diagnoses over the past 20 years, physicians are changing treatment approaches as specialists debate how aggressively to treat the condition.
While 4,800 women were diagnosed with DCIS in 1983 that number had soared to 50,000 by 2003, the June 22 New York Times reported.
The article cited a review study published in the March 17, 2004, Journal of the National Cancer Institute (JNCI) that found a trend toward less aggressive DCIS treatment from 1992 through 1999. The review, which looked at data from more than 25,000 DCIS patients, found that mastectomy rates had dropped from 43% to 28% over that period, while fewer patients undergoing lumpectomy also underwent radiation.
The JNCI review also found significant geographic variations in DCIS treatment. According to the New York Times, many experts agree that mastectomy is not warranted for DCIS unless the lesions are diffuse and that lymph node biopsy is unnecessary except in cases of aggressive DCIS.
Experts disagree, however, over whether radiation should accompany lumpectomy. Those that advocate radiation with lumpectomy say it reduces the 10-year risk of invasive breast cancer from 15% to 7%. Others say that blanket radiation treatment with lumpectomy is unnecessary.
The JNCI abstract is online.
The New York Times is online.
Antitumor necrosis factor-alpha agents are effective in treating patients with spondyloarthritis who have not responded to nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate.
This systematic review and consensus report, abstracted in the May-June ACP Journal Club, analyzed a number of clinical trials evaluating antitumor necrosis factor-alpha agents (infliximab and etanercept) in patients with spondyloarthritis. The collective data show that these agents relieve symptoms such as pain, stiffness and swelling; improve physical function and quality of life; delay progression of structural damage; and prevent disability.
While the review addressed important issues, two points should be considered, according to ACP Journal Club reviewers. First, only case-report evidence was available on the role of anti-TNF-alpha therapy in reactive arthritis, undifferentiated spondyloarthropathy or arthropathy in inflammatory bowel disease.
Second, drug regulatory agencies have not approved switching between different anti-TNF-alpha agents. In addition, there is no long-term safety data on anti-TNF-alpha therapy in spondyloarthritis.
Reviewers concluded that anti-TNF-alpha therapies have proven effective in the short term, but more studies are needed to determine their long-term efficacy and safety.
The ACP Journal Club review is online.
In comments sent last week to the CMS, ACP made several recommendations that would make the Stark II interim final rule more flexible for physicians, particularly in matters related to recruitment and incentives for information technology.
In a June 24 letter, the College applauded the new flexibility written into the interim rule on in-office ancillary services and on granting a grace period to help physicians not in compliance with rule exceptions.
However, the College called for modifications in several areas of the interim rule. Specifically the College urged the CMS to include the following:
Work with the Office of the Inspector General to create a new safe harbor under the anti-kickback statute related to information technology for physicians participating in community-wide health information systems.
Modify the physician recruitment exception to pay recruited physicians--when they are replacing physicians who have retired, relocated or died--a pro rata share of overhead costs attributed to the physician being replaced, to not penalize hospitals in recruitment efforts.
Extend an exception allowing for obstetrical malpractice subsidies to all medical specialties.
The College's comments are online.
The College has endorsed a Senate bill aimed at improving the quality and the coordination of care for seniors with multiple chronic care conditions.
In a June 24 letter to Sen. Blanche Lincoln (D-Ark.), ACP President Charles K. Francis, FACP, thanked her for introducing the "Geriatric and Chronic Care Management Act of 2004." According to a College press release issued last week, the bill would create different financial incentives for strategies to improve geriatric chronic care, including:
- Care management that would include the development of a care plan and multidisciplinary team conferences.
- Coordination with other providers.
- Medication management and patient and family caregiver education
- Round-the-clock telephone consultations.
The ACP press release is online.
The College letter is online.
Voicing support for an upcoming CMS chronic care improvement pilot program, the College has recommended ways to boost physician involvement in that project and enhance the use of decision-support tools in chronic care.
In a June 23 letter to CMS administrator Mark B. McClellan, ACP Member, College President Charles K. Francis, FACP, urged the CMS to adopt a physician-guided model of care in the disease management pilot program mandated by last year's Medicare reform bill.
In the letter, the College called on the CMS to have one or more of its pilot sites test incentives aimed at physicians, instead of limiting incentives to disease management companies or large health plans. Incentives should be structured, the letter pointed out, to give bonus payments to physicians who use health information technology.
The letter noted that the College also supports the project's statutory mandate for using clinical decision support tools, such as ACP's Physicians' Information and Education Resource (PIER) product. The College would support project bids, the letter stated, that include physician incentives, performance goals and the use of effective electronic tools, like PIER.
A copy of the letter is available online.
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A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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