Surgery News - December 2008 - (Page 4) S U R G E R Y NEWS • D E C E M B E R 2 0 0 8 THE 20/20 T Steep Costs Likely for ICD-10 Transition bucks, according to a cost analysis commissioned by the Medical Group Management Association and other provider groups. The cost analysis, which was conducted by Nachimson Advisors, puts the total cost of implementation for a typical small practice with three physicians at $83,290. A typical medium practice with 10 providers would end up spending $285,195, and a typical large practice with 100 providers would spend about $2.7 million, according to the estimate. The estimate includes costs associated with education, process analysis, changes to superbills, information technology changes, increased documentation costs, and cash flow disruption. For example, because of the greatly expanded number of codes, a one-page superbill would no longer be sufficient to capture all the necessary codes and a longer superbill would likely be impractical. Instead, practices may need to consider using automated tools to help with coding, according to the analysis. In a letter to the Health and Human Services Department, groups including the MGMA, the American Medical Association, and more than 100 other provider organizations and state medical societies urged the agency to provide more time to implement both the ICD-10 coding sets and the X12 Version 5010 technical standard for electronic transactions that is also being required by HHS. The department should provide at least 36 months to adopt and implement the 5010 standard in order to accommodate testing at all levels. And physicians and other health care providers will need at least another 60 months after the industry has demonstrated readiness with the 5010 standard before adopting ICD10, the letter said. “Physicians are deeply concerned that a hasty transition to a new, complex coding system will result in chaos for all involved, especially if the transition is done in tandem with the implementation of HIPAA’s new electronic claim standard (5010),” Dr. Joseph M. Heyman, AMA board chair, said in a statement. “Costs, training, and impact of the new rule have been underestimated by HHS, and must be readdressed before going forward.” The move to a National Provider Identifier was one of the simplest changes called for under HIPAA, said Robert Tennant, senior policy advisor at MGMA, and it still took 4 years to complete. The idea that physicians, hospitals, laboratories, and health plans will be able to implement a much more complex transition to ICD-10 in the next 3 years is unrealistic, he said. “History tells us that time frame simply won’t work,” he said. While MGMA supports the move to ICD-10, a rushed transition to the new system could affect patient care and financially squeeze already struggling physicians, Mr. Tennant said. There’s no question that even if the time frame for adoption is extended by HHS, physicians will face significant implementation costs, Mr. Tennant said. However, if physicians and the rest of the industry don’t have adequate time to prepare, the price tag could be even higher, forcing some physicians to put off needed investments such as the adoption of electronic health records, he said. ■ The cost estimate is available online at http://nachimsonadvisors.com/ products.aspx. VISION B Y M A RY E L L E N S C H N E I D E R Else vier Global Medical Ne ws he federal government’s plan to transition from the ICD-9-CM diagnosis and procedure code set to the ICD10 by 2011 could cost physicians big BRIEF SUMMARY ENTEREG® (alvimopan) Capsules The following is a brief summary only; see full prescribing information for complete product information. WARNING: FOR SHORT-TERM HOSPITAL USE ONLY ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. [see Warnings and Precautions (5.1 and 5.2)] 4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. 5 5.1 Pain WARNINGS AND PRECAUTIONS Myocardial Infarction in a 12-Month Study in Patients treated with Opioids for Chronic Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan. 8 8.1 There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies in patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established. 5.2 Distribution Program for ENTEREG ENTEREG is available only to hospitals that enroll in the E.A.S.E. program. To enroll in the E.A.S.E. program, the hospital must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of alvimopan; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital. Contact the E.A.S.E. program at 1-866-4ADOLOR (1-866-423-6567). 5.3 Opioid Tolerance and Gastrointestinal-Related Adverse Effects Patients recently exposed to opioids are expected to be more sensitive to the effects of -opioid receptor antagonists. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would likely be limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials; therefore, ENTEREG 12 mg capsules should be administered with caution to these patients. 5.4 Severe Hepatic Impairment In patients with severe hepatic impairment, there is a potential for 10-fold higher plasma levels of drug [see Clinical Pharmacology (12.3) of full prescribing information]. There are no studies of ENTEREG in patients with severe hepatic impairment undergoing bowel resection. Because of the limited data available, ENTEREG is not recommended for use in patients with severe hepatic impairment. 5.5 End-Stage Renal Disease No studies have been conducted with end-stage renal disease. ENTEREG is not recommended for use in these patients. 5.6 Bowel Obstruction Use of ENTEREG in patients undergoing surgery for correction of complete bowel obstruction is not recommended. 6 6.1 ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The data described below reflect exposure to ENTEREG in 1,650 patients in 9 placebo-controlled studies worldwide. The population was 19 to 97 years old, 68% were female, and 83% were Caucasian; 61% were undergoing bowel resection surgery. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment). Table 1 presents treatment-emergent adverse reactions reported in 3% patients treated with ENTEREG and for which the rate for ENTEREG was 1% than placebo. Treatment-emergent adverse reactions are those events occurring after the first dose of study medication treatment and within 7 days of the last dose of study medication or those events present at baseline that increased in severity after the start of study medication treatment. Table 1. Treatment-Emergent Adverse Reactions That Were Reported in 3% of Either Bowel Resection Patients Treated With ENTEREG or All Surgical Patients Treated With ENTEREG and for Which the Rate for ENTEREG Was 1% Than Placebo Bowel Resection Patients Placebo (n = 986) % 4.2 3.9 4.6 4.5 8.5 1.7 2.1 ENTEREG (n = 999) % 5.2 4.0 7.0 3.1 9.5 3.3 3.2 All Surgical Patients Placebo (n = 1,365) % 5.4 7.6 4.8 7.7 7.5 2.6 2.3 ENTEREG (n = 1,650) % 5.4 9.7 5.9 8.7 6.9 3.4 3.5 USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in pregnant rats at about 68 to 136 times the recommended human oral dose based on the body surface area and intravenous doses of about 3.4 to 6.8 times the recommended human oral dose based on the body surface area and in pregnant rabbits at intravenous doses at about 5 to 10 times the recommended human oral dose based on the body surface area and have revealed no evidence of impaired fertility or harm to the fetus due to alvimopan. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8.2 Nursing Mothers Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. It is not known whether alvimopan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ENTEREG is administered to a nurs http://nachimsonadvisors.com/products.aspx
Table of Contents Feed for the Digital Edition of Surgery News - December 2008 Surgery News - December 2008 Contents The 20/20 Vision: Health Reform News From the College: Nominations Thoracic: Breathing Easier Postop Management: Renal Failure Surgery News - December 2008 Surgery News - December 2008 - Contents (Page 1) Surgery News - December 2008 - Contents (Page 2) Surgery News - December 2008 - Contents (Page 3) Surgery News - December 2008 - Contents (Page 4) Surgery News - December 2008 - Contents (Page 5) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 6) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 7) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 8) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 9) Surgery News - December 2008 - News From the College: Nominations (Page 10) Surgery News - December 2008 - News From the College: Nominations (Page 11) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 12) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 13) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 14) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 15) Surgery News - December 2008 - Postop Management: Renal Failure (Page 16) Surgery News - December 2008 - Postop Management: Renal Failure (Page 17) Surgery News - December 2008 - Postop Management: Renal Failure (Page 18) Surgery News - December 2008 - Postop Management: Renal Failure (Page 19) Surgery News - December 2008 - Postop Management: Renal Failure (Page 20)
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