Topics covered in this issue include: 1) National Managed Care Plans Stop Paying for Anesthetic in Colonoscopy 2) Managed Care Organizations Will not Pay for Care Resulting From Preventable Errors 3) Is Progression-Free Survival a Real Clinical Benefit? 4) Do Practice Patterns Reflect National Recommendations in Gallbladder Cancer? 5) National HMO Bases Chemotherapy Coverage on Guideline Compendium 6) Pap Test Screening: Better Testing Versus More Frequent Office Visits 7) CMS Issues Instructions for EPO Claims Reporting
Click here to view as PDF.National Managed Care Plans Stop Paying for Anesthetic in Colonoscopy
Aetna (Hartford, CT) has announced that it will join Humana (Louisville, KY) and WellPoint (Woodland Hills, CA) in no longer reimbursing for a drug they deem is medically unnecessary for most patients undergoing colonoscopy. The drug in question is propofol, the anesthetic used in many patients, but is not proven to result in better outcomes.
Aetna’s decision was based on its finding that although 77% of patients undergoing colonoscopy in the New York metropolitan area received the drug, other regions demonstrated use rates of 10% or less. The health plan found that outcomes were unrelated to the drug’s use. Additionally, no rescue drug is presently available for propofol, and it is a rapid-acting product. Although the drug is generic and is relatively inexpensive, the health plan pointed out that it seems to be an unnecessary risk, a belief that is supported by major professional gastroenterological associations.
Furthermore, the use of propofol generally requires the services of an anesthesiologist, which can add between $300 and $1,000 to the cost of the colonoscopy. Aetna will continue to pay for the use of propofol in patients over 65 years of age, those who are pregnant, and patients in whom the use of alternative drugs may be risky, but the company believes this may cover only 10% to 20% of colonoscopies performed..
The open question is whether this payment decision will result in greater patient discomfort and subsequent resistance to undergoing routine colonoscopy in the future. Patients will likely be given a combination of a sedative and tranquilizer, but this does not anesthesize the patient during the procedure. Others have experimented with the use of small doses of propofol administered without the use of an anesthetist, while using the sedative-tranquilizer combination, with success. However, under the new policy, the use of propofol will still go uncovered by the three national insurers. For now, UnitedHealthcare has indicated that it does not plan on following suit.
Feder BJ: Aetna to end payment for a drug in colonoscopies.
December 28, 2007.
New York Times
Managed Care Organizations Will Not Pay For Care Resulting From Preventable Errors
In a move widely seen as following Medicare’s lead, large managed care organizations announced recently that they would no longer pay hospitals for the care of treating a list of eight preventable injuries and infections. This may be the precursor to a much larger list of medical errors, however.
In October 2008, the Centers for Medicare and Medicaid Services will implement its new policy that it will not reimburse for services provided to treat complications of the medical errors listed in the Table. Aetna (Hartford, CT) and WellPoint (Woodland Hills, CA) have announced that they will follow suit, and apply this principle to their commercial populations. They will utilize a list of events that should “never occur,” according to work by the National Quality Forum, which includes, maternal death in a low-risk pregnancy, failure to prevent bedsores, or infection through the use of contaminated devices. The insurers also report that in 2009, the list of non-reimbursable services will include treatment for blood clots in the legs and lungs while under hospital care, pneumonia contracted through ventilator use, and nosocomial blood infections. The Table also lists some of the other medical errors that the National Quality Forum indicates as those should never occur.
UnitedHealth Group (Minneapolis, MN), Cigna (Philadelphia, PA), Humana (Louisville, KY), and the Blue Cross Blue Shield Association (Chicago, IL) are also examining similar policies for use in the near future. They hope to force hospitals to improve their safety records and procedures through the one incentive they understand well—payment.
Sample of Nonreimbursable Services to Fix Medical Errors
Surgical tool left in body*
Infections at the site of surgery*
Mismatched blood transfusions*
Catheter-induced urinary tract infections*
Patient falls in hospital*
Development of bedsores*
Allowing patient to wander
Artificial insemination with wrong donor egg or sperm
Operation performed on the wrong limb
Wrong operation performed on patient
Using contaminated devices or pharmaceuticals
Discharging the wrong infant to a mother
Disability of mother after a low-risk delivery
Patient kidnapping or sexual assault
*Centers for Medicare and Medicaid Services measure.
Fuhrmans V: Insurers stop paying for care linked to errors: Health plans say new rules improve safety and cut costs; Hospitals can’t dun patients.
January 15, 2008.
Wall Street Journal
Is Progression-Free Survival a Real Clinical Benefit?
Clinical oncology studies strive to demonstrate how an intervention improves patients’ outcomes, but managed care organizations, in making their coverage decisions, often ask whether the outcomes altered in the study are the outcomes of importance. The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee has now decided to address this question with progression-free survival (PFS).
It has been well accepted that PFS was a surrogate marker for improved overall outcomes, and most clinicians believe that if the patient has significantly improved PFS, this will equate to better overall survival. In 1999, the Committee had ruled that time-to-progression was not a valid primary endpoint for clinical trials conducted by drug manufacturers seeking approval for first-line cytotoxic breast cancer therapy.
Although the patient’s and physician’s psychological state may be improved if the cancer is not progressing, this does not mean that symptoms are not apparent and that the chemotherapy being used does not detract from quality of life. However, the FDA has utilized time-to-progression as the bases for approval in lapatinib, used as second- and third-line therapy in metastatic breast cancer, and it has used PFS in the approval process for ixabepilone, also used after first-line therapy has been attempted.
Measuring variables related to progression is very difficult, according to the FDA, and this is one of the key problems in using PFS as an endpoint: How to tell once progression occurs, particularly if information about disease progress at baseline is incomplete?
The Committee did not officially change its position on the value of PFS; it voted 5—4 in December to not approve bevacizumab’s expanded indication for first-line metastatic breast cancer based on its positive PFS results. However, there does seem to be some wiggle room, as the FDA acknowledges that it may well be of clinical benefit, except that it cannot be reliably measured at this time.
Marson B: Progression-free survival represents clinical benefit, but how much?
The Pink Sheet
Do Practice Patterns Reflect National Recommendations in Gallbladder Cancer?
Survival in patients with localized T2 gallbladder cancer has been poor, and radical cholecystectomy has been recommended by national groups to improve outcomes. Surgical oncologists from Santa Monica, California, sought to determine if this recommendation was being followed by oncologists throughout the country.
Using the Surveillance, Epidemiology and End-Results (SEER) Registry, the researchers evaluated all patients diagnosed with localized T2 gallbladder cancer who were diagnosed between 1988 and 2002. They evaluated a population of 382 patients (280 women, 102 men) who underwent cholecystectomy alone (238 patients), cholescystectomy and lymph node dissection (76), radical cholecystectomy (14), or other treatment. Three hundred twenty-eight patients underwent some form of cholecystectomy. The remaining 54 patients underwent no procedure or a different procedure and were not part of the comparative analysis.
Median survival was 14 months for all patients, and five-year survival was greatest for the patients undergoing radical cholecystectomy. In this study, only 4% of patients were given treatment in line with national recommendations for localized T2 gallbladder cancer.
Wright BE, Lee CC, Iddings DM, et al: Management of T2 gallbladder cancer: Are practice patterns consistent with national recommendations?
Am J Surg
National HMO Bases Chemotherapy Coverage on Guideline Compendium
Drugs and Biologics Compendium
A national managed care organization has decided to base reimbursement of cancer chemotherapy on a unified source of guidelines, which will serve as a reference for all coverage decisions. UnitedHealthcare (Minneapolis, MN) has announced that the National Comprehensive Cancer Network’s (NCCN’s) guidelines will serve as its reference.
An alliance of 21 cancer centers, NCCN (Fort Washington, PA) produces guidelines based on available scientific evidence and expert consensus opinion. Information from NCCN guidelines is currently used by varied organizations, but it had not yet been relied upon solely. Information from multiple sources of medical literature has been typically used to inform coverage practices. The recommends drug and biologic treatment options for various clinical presentations.
“This new policy provides clinicians, patients, and our customers with a respected independent reference source for use in making chemotherapy coverage decisions,” stated Lee Newcomer, MD, Senior Vice President, Oncology, for UnitedHealthcare, in a press release. The policy takes effect March 15, 2008.
UnitedHealthcare becomes first company to base chemotherapy drug coverage on National Comprehensive Cancer Network Compendium (press release). January 16, 2008.
Pap Test Screening: Better Testing Versus More Frequent Office Visits
New genetic tests can detect the presence of the human papilloma virus (HPV), with a false-negative rate of only 5%. This compares with a false-negative rate of three to eight times higher for the Pap test. Yet, although the new test costs only $12 more than the Pap test, why have the HPV tests not been used by 75% of women?
At least part of the problem lies with the physician, according to an article in . The HPV test need only be given every three years, as opposed to annual screening with the Pap smear. It may be possible that physicians fear (1) loss of revenue if women don’t have to see the doctor annually and (2) other routine testing schedules might be disrupted without the regular Pap screen visit.
Kaiser Permanente added the use of the HPV screen along with Pap smears, which has helped to reduce the number of inconclusive and false-positive Pap smear results. Other experts believe that the HPV screen should be used as a full replacement for the Pap smear.
However, it is difficult to decide how much of these arguments are based on commercial interests. The number of manufacturers of HPV screening products has increased steadily, and unsurprisingly, some of the biggest proponents of replacing the Pap screen are manufacturers of the genetic test.
Miller CC: The cancer that shouldn’t be.
January 28, 2008.
CMS Issues Instructions for EPO Claims Reporting
Effective January 1, 2008, providers must begin reporting patients’ most recent hemoglobin or hematocrit concentrations on Medicare claims for patients receiving either erythropoiesis- stimulating agents (ESAs) or part B antianemia drugs (not self-administered) used to treat patients undergoing cancer treatment.
Based on recent safety alerts issued by the Food and Drug Administration and reports of a higher risk of serious adverse events and risks of complications in patients using ESAs, the Centers for Medicare and Medicaid Services (CMS) issued its national coverage determination in July 2007, which ties reimbursement of ESA use in patients who do not have end-stage renal disease (ESRD) to reporting of appropriateness data based on the patient’s hemoglobin and hematocrit blood levels.
The Centers for Medicare and Medicaid Services also announced that if an ESA is being used for a patient who does not have ESRD, one of three new Healthcare Common Procedure Coding System modifiers must be recorded in order to receive reimbursement. These modifiers are listed in the Table. This requirement was also effective January 1, 2008.
HCPCS modifiers for ESA use in patients who do not have ESRD
HCPCS Code Modifier
ESA, anemia, chemotherapy-induced
ESA, anemia, radiotherapy-induced
ESA, anemia, not related to chemo- or radiotherapy
HCPCS = Healthcare Common Procedure Coding System;
ESA = erythropoeisis-stimulating agents; ESRD = end-stafe renal disease.
Reporting of hematocrit or hemoglobin levels on all claims for the administration of erythropoiesisstimulating agents (ESAs), implementation of new modifiers for non-ESRD indications, and reporting of hematocrit or hemoglobin levels on all non-ESRD, non-ESA claims requesting payment for anti-anemia drugs.
MM5699; January 14, 2008.