In the News for the Week of 8-7-07
- New final rules for inpatient reimbursement from CMS
- Annals of Internal Medicine:
- Geriatric conditions are common but often overlooked
- Expert group: Evidence on benefits of counseling patients about preventing car accident injury is inconclusive
- Rosiglitazone should stay on the market but get warnings, FDA advisors say
- Advisors want to ease restrictions on acne drug
- Constipation treatment available again to some patients
Health information technology
- Small practices to benefit from new standard for lab test reporting
- Master represents College in developing new accreditation program
Last week both houses of Congress passed legislation expanding the State Children’s Health Insurance Program (SCHIP), earmarking federal tobacco taxes to fund the expanded budget.
On Wednesday the House of Representatives passed the Children’s Health and Medicare Protection (CHAMP) Act (H.R. 3162), which will expand the SCHIP budget by $47.4 billion over five years and add an additional 5 million uninsured children to the program. On Friday the Senate passed a less expensive version of the legislation, voting to add $35 billion to the budget over the next five years and extend coverage to an additional 3.2 million uninsured.
In a letter to House leadership expressing support for the CHAMP Act, ACP President David C. Dale, FACP, praised legislators for using increases in federal taxes on tobacco products to fund the expanded SCHIP budget. The added benefit of using this method of funding, he said, is that higher taxes have been shown to reduce smoking rates.
In addition to reauthorizing and expanding SCHIP, the House legislation also includes provisions to fix Medicare payments to physicians. Physician payments are scheduled to be cut by 10% in 2008 and reduced further in subsequent years due to a flaw in the formula used to calculate physician payments. Under the CHAMP Act, physician payments would increase in 2008 and 2009, although further legislation will be needed to avert payment cuts after 2009. The Senate version of the bill does not include any provisions to fix Medicare payments.
In his letter to House leadership, Dr. Dale expressed support for the CHAMP Act's method of funding the SCHIP expansion and fixing Medicare payments. In addition to the tobacco tax, the House bill stipulates a reduction in payments to Medicare Advantage plans. According to the Congressional Budget Office, Medicare Advantage plans are paid an average of 12% more than traditional Medicare, despite being available to only a limited number of beneficiaries.
Dr. Dale's letter to House leadership is online.
The CMS set new restrictions last week on payments for erythropoietin drugs, which are used to treat anemia in cancer patients. The new restrictions were less stringent than those originally proposed, but still drew protest from a manufacturer of the drugs.
Under the new national coverage determination, Medicare will cover the drugs for patients with anemia caused by chemotherapy, but not for those with anemia due to cancer alone. Patients with a hemoglobin level of 10 grams per deciliter or less will be eligible for coverage. In May, CMS had proposed limiting the drugs to patients with hemoglobin levels of 9 or less, but the agency modified the regulations based on negative response from physician and patient groups, the July 31 New York Times reported.
The new regulations also limit the drug use to a maximum of eight weeks after a chemotherapy session ends and limit dose escalation levels. The rules do not address use of the drugs for myelodysplastic syndrome (a premalignant syndrome that can transform into acute myeloid leukemia) and CMS officials said that coverage determination would be left to local Medicare contractors.
Amgen, which manufactures the drugs under the brand names Aranesp and Epogen, challenged the policy, suggesting that the hemoglobin limit would require more patients to receive blood transfusions and negatively impact quality of care. They also argued that the new rule is contrary to the FDA approval and labeling of synthetic erythropoietin, said the Aug. 2 New York Times. Last March, the FDA added a black-box warning to the drugs which urged physicians to use the lowest dose necessary to raise hemoglobin to the lowest level that will avoid the need for a blood transfusion.
The CMS press release is online.
CMS recently issued final rules on payment for inpatient hospital services and inpatient rehabilitation facilities.
In a rule issued Aug. 1, CMS announced that payments to hospitals in fiscal year 2008 would increase by approximately 3.5%. CMS would also begin to adjust payments by illness severity, with 745 new diagnosis-related groups (DRGs) replacing the 538 current ones. As a result, hospitals that care for sicker patients will receive higher payments than those whose patients are less sick. The changes in DRGs will be phased in over two years.
Under the new rule, CMS will now require hospitals to report "secondary diagnoses," or diagnoses that develop after hospital admission, of eight specific conditions, including hospital-acquired infections. CMS will stop paying hospitals a higher rate for secondary diagnoses of these conditions as of fiscal year 2009. The rule also requires that physician-owners of specialty hospitals inform referred patients of their ownership. Hospitals also must notify patients in writing if a medical doctor is not on site at all times, as well as provide a plan for dealing with emergencies that occur while a doctor is unavailable.
CMS also announced on July 31 that payments to inpatient rehabilitation facilities would increase by 3.2% in fiscal year 2008 and that the high-cost outlier threshold would increase from $5,534 to $7,362. CMS will also keep in place the "75% rule," the method by which it currently determines whether a facility can be classified as an inpatient rehabilitation facility. In addition, as of July 1, 2008, facilities will no longer be permitted to include patients' comorbid conditions when calculating adherence to the 75% rule.
The following articles will appear in the Aug. 7, 2007 online issue of Annals of Internal Medicine. The full text is available to College members and subscribers online.
Geriatric conditions are common but often overlooked. A study of data from a large national survey found that geriatric conditions, such as cognitive impairment, falls and incontinence, were common among adults age 65 years and older and increased in frequency with age. At aged 65, almost half (49.9%) had one or more geriatric conditions. Some conditions were as prevalent as common chronic diseases, such as heart disease and diabetes, and presence of geriatric conditions was strongly associated with disability. Most geriatric conditions can be treated or at least alleviated. Authors note that current models of care that focus on a single disease, or the care management model directed toward patients with multiple illnesses and disability, do not recognize the importance of geriatric conditions on quality of life and as markers for decline and disability.
Expert group: Evidence on benefits of counseling patients about preventing car accident injury is inconclusive. Motor vehicle accident injuries are the leading cause of death among Americans between the ages of 3 and 33. Counseling during regular physician visits about the proper use of child safety seats, seat belts and the dangers of drunk driving might reduce death and injury from car accidents. After a review of published research on the effects of such counseling, the U.S. Preventive Services Task Force (USPSTF) concluded that office-based counseling did not provide any more benefit than other programs that promote driving safety. And most studies were done before the enactment of child safety seat legislation.
Diabetes drug rosiglitazone (brand name Avandia) should not be pulled from the market although it does raise patients’ risk of heart attack, an FDA advisory committee concluded last week. The expert advisors voted almost unanimously in both decisions and also recommended that the drug carry a strict warning label.
The panel reviewed analyses of the drug by inside and outside experts, and received differing recommendations from drug manufacturer representatives, agency scientists and outside experts. The meeting highlighted the unusual level of disagreement on this issue among experts within the FDA, said the July 31 New York Times.
Among experts testifying before the committee were the authors of a new analysis of rosiglitazone published in the Annals of Internal Medicine. The researchers reanalyzed the data used in the New England Journal of Medicine article which first raised public concern about side effects of the drug. The authors pointed out flaws in the original analysis and concluded that the evidence was uncertain, with neither increased nor decreased risk of heart attack and death from cardiovascular disease established. The study was released early online and will appear in the Aug. 7 print edition of Annals.
The Annals of Internal Medicine article is online.
The New York Times is online.
A panel of FDA advisors recommended last week that the agency ease limits on women’s access to isotretinoin (brand name Accutane), an acne drug known to cause birth defects.
Data reviewed by the panel and reported in the Aug. 1 Washington Post showed that at least 159 women became pregnant while taking the drug in the past 16 months, despite their enrollment in a drug manufacturer program which required them to pledge not to become pregnant. Under the current FDA regulations, women are also required to fill their prescriptions within seven days of seeing their doctor, pass pregnancy tests before each refill, and either use two forms of birth control or pledge abstinence.
The panel recommended that women should be required to fill the prescription within seven days of a pregnancy test, rather than a doctor visit, and if they miss that deadline, they should be permitted to take another pregnancy test. The 18 panel members unanimously approved the recommendation, which now goes to the FDA for review.
The Washington Post is online.
The FDA last week loosened restrictions on tegaserod maleate (brand name Zelnorm), a drug used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation. Women younger than age 55 who do not have heart problems will be eligible to take the drug under the FDA’s treatment investigational new drug protocol.
The FDA asked manufacturer Novartis to suspend sales and marketing of the drug in March after trials found that it increased patients’ risk of heart attack, stroke and unstable angina. The drug will remain off the market to the general public. Only patients who meet the FDA criteria and whose physicians deem the drug medically necessary will be permitted to take it after signing a consent form warning of the potential risks and benefits.
The FDA release is online.
Health information technology
Health Level Seven, a national standards body for clinical information systems, is completing a new data standard for reporting laboratory test results to electronic health record (EHR) systems. The standard, called “ELINCS”, was developed in collaboration with the California HealthCare Foundation at the request of the federal government.
The goal of ELINCS is to do away with the myriad of ad hoc data formats used by different laboratories and EHR products. Currently, electronic streaming of lab results requires customized software, or interfaces, between each lab and EHR.
The ELINCS standard will be especially helpful to practices that deal with more than one lab, and small physician practices that have or plan to have EHRs, said Sophia Chang, ACP member and director of the Better Chronic Disease Care program at the California HealthCare Foundation. To date, the absence of a single data standard has meant that physician practices often must build and maintain or purchase custom data interfaces so their systems can electronically receive lab results, something that small practices often cannot afford.
Surveys have shown that smaller practices with EHRs (specifically, practices with 10 or fewer physicians) are less likely than larger practices to enjoy the benefits of electronic lab reporting, which hinders the EHR’s ability to provide clinical decision support, calculate and report quality measures and promote patient safety, said Dr. Chang. Four pilot projects tested the ELINCS standard in 2006 and were considered successful. A number of EHR vendors and major laboratories (including Quest Diagnostics and LabCorp) have already implemented ELINCS interfaces.
More information about ELINCS is on the California Healthcare Foundation's Web site.
N. Thomas Connally, MACP, recently represented ACP on the standards committee for URAC’s new Pharmacy Benefit Management Accreditation program. The new program will be available to health plans and stand alone pharmacy benefit management companies (PBMs) in the commercial market.
The standards for accreditation include minimum requirements relating to appeals rights for physicians and patients when denied prescribed medications, changes in formularies, standards for composition of pharmacy and benefits committees that create the formularies, how a PBM communicates information to plan subscribers, and availability of customer call centers for patients to get information from the PBM.
The standards are voluntary and PBMs will choose whether or not to participate in the program. PBMs are companies that administer drug benefit programs for employers and health insurance carriers. According to URAC, an independent, non-profit organization that promotes health care quality through accreditation and certification programs, approximately 70% of Americans receive their prescription medications through PBMs.
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Copyright 2007 by the American College of Physicians.
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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