IROs
Independent Review Organizations:
Consumers Gain Needed Care When Unaffiliated
Medical Experts Review Health Plan Denials

A Report on the Texas Independent Review Process
Prepared by Consumers Union Southwest Regional Office
May 2002


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Report (PDF format)

Number of Inpatient Days

A large portion of the cases reviewed by IROs dealt specifically with the number of days a patient spent as an inpatient for a wide variety of physical ailments. In all, there were 60 such disputes: 52 disputes over the number of days needed, and eight where the HMO denied coverage altogether. In about half of the cases, disputed treatment was partially or fully approved by the reviewers. Because the conditions vary considerably, our conclusions are limited.

Of the eight cases denying the need for any hospital care, IROs overturned only two. The reviewers tended to agree that patients did not need to stay in the hospital for physical exams, tests, oral medication, and physical therapy.(34)

When doctors admit a patient with an unknown problem for testing, an HMO will sometimes deny part of the stay if serious conditions are ultimately ruled out. A woman took a stress test for chest pain. Because she experienced serious chest pain during this test, doctors admitted her as an inpatient in order to assess her condition and rule out a heart attack. Her doctors conducted a CT scan, which resulted in two more days of hospitalization. When this test came back negative, the woman underwent a heart catheterization for diagnosis, which required one more hospital day. The HMO later denied coverage for the last days of inpatient care. The IR reviewer disagreed, finding that until she received a conclusive diagnosis, her stay was necessary.(35)

A two-year-old girl was admitted to the hospital because of lethargy, vomiting, and a sudden temperature elevation of 104 degrees. When she arrived on March 7, doctors conducted tests and drew a blood culture. After admission with the preliminary diagnosis of ear infection, she started intravenous antibiotic therapy. The next day, the blood culture came back positive for gram-positive cocci. Hosptial staff drew another blood culture after receiving the first test results. She continued to have low-grade fever, and by March 9, the infection was identified as penicillin-resistant Streptococcus pneumonia. Although the child was completely stable, the physician opted to wait for the second blood culture, which came back negative on March 11, at which time the child was released. The HMO denied coverage for the child's March 10 stay, since she was stable and the infection appeared to have been identified.

The IR reviewer, however, held that the extra stay was necessary to ensure the child received the appropriate care. Because the infection was penicillin-resistant, the physician had reason to be concerned that it may be resistant to other antibiotics. Furthermore, because the child was a daycare attendee, she was at high risk for having drug-resistant pneumonia. The reviewer concluded that the child received "excellent and appropriate medical care" and the HMO should have covered her hospitalization on March 10.(36)

These cases indicate a strong tension between the need to cut unnecessary medical costs and the need to protect patients whose condition may not be fully diagnosed. While many IRO decisions supported an outpatient approach to testing, not every patient can be approached in the same way and some cases support the need for hospital based diagnostic care. They also highlight the most common feature of many utilization review decisions for hospital care-the decision to trim the hospitalization by two days, one day or even a few hours.

In at least 22 other cases, the HMOs denied coverage for two days, one day or even a few hours of inpatient care, and reviewers only overturned seven of these denials. These cases came down to patients, HMOs, physicians, and IROs grappling with how much inpatient care is medically needed almost down to the hour. The reviewers look at the medical records and history of each patient, taking into consideration the seriousness of their illnesses, whether they had been placed on new medication, and if their care could have been appropriately provided on an outpatient basis.

A woman, suffering from severe dizzyness, had been admitted to intensive care, and the doctors found that her diabetes was poorly controlled. The hospital, HMO, and IRO all had different opinions as to when the patient should have been released. The hospital released her on the seventh day, the HMO said she should have left on the fifth day, and the IRO determined that she should have been released on the sixth day.(37)

A managed care plan denied coverage to woman who had undergone a hysterectomy because the HMO believed that her improvement, and ability to eat and take oral medication, indicated that she was well enough to be released after dinner one evening, rather than her actual release the next morning.(38) A man who underwent surgery for sleep apnea stayed in the hospital one full day. Here, the HMO and the reviewer agreed that he should have been released the day of the surgery rather than the next morning because, by the 18th hour after surgery, he could begin drinking water and taking oral medication. In general, if the patient could begin taking oral medication and eating, then the HMO and reviewers would both deny continued inpatient care.(39)

Sometimes the HMO will deny hospital days when hospitals cannot efficiently schedule tests or deliver test results. Aetna and a reviewer agreed that a patient could have been released earlier if the doctor had asked to have test results called in to him instead of waiting for them to appear in the chart.(40) Prudential and TMF concurred that a patient who needed a cardiac catheterization should not get two days of coverage because the procedure should have been done on Saturday, rather than Monday, the day on which the hospital scheduled it.(41) But, in a similar case, when Aetna said a patient's heart catheterization should have been scheduled a day earlier, Independent Review Inc. disagreed and required the company to pay for the full stay.(42) An Aetna patient who needed a CT scan had to wait because the doctors could not immediately obtain the I.V. access needed. According to the reviewer, this is a "recognizable reason" for failing to perform this procedure sooner.(43)

Patients of Aetna US Healthcare asked for 26 reviews related to the number of inpatient days needed for a variety of physical conditions. Reviewers overturned almost three quarters of them (19 cases).

Prescription Drugs

ompared to the average "overturn rate," most HMO denials we reviewed regarding specific prescription drugs were upheld by the independent review system. IROs reviewed 19 appeals concerning prescription drugs and only overturned six (32 percent).

Surprisingly, a small number of drugs were disputed more than once. Of the 19 disputes over specific prescriptions, seven involved Lamisil, a drug that treats foot fungus, and two each concerned Lipitor and a juvenile growth hormone. The remaining seven disputes concerned a wide range of drugs.

In four of the Lamisil disputes, Aetna said that doctors should first obtain proof of the degree of their infection with either a fungal culture or PAS stain. The reviewers agreed.(44)

Lamisil, as well as similar oral fungal medications, has been linked with patients' liver problems. These problems prompted the Food and Drug Administration in June 2001 to issue a health warning, requiring that Lamisil carry stronger warnings about potential liver damage.(45) The new labels now recommend that health-care professionals obtain nail specimens for testing to confirm the diagnosis before prescribing medication for fungal nail infections.(46) Both HMOs and reviewers were strong in their opinions that, before prescribing, doctors should demonstrate, using standard tests for fungal infection, that the patients indeed need this oral medication.

Lipitor treats high cholesterol. During the study period, Aetna removed Lipitor from its formulary and required patients to use Zocor or another drug instead. The formulary change affected Texas patients upon their plans' 2001 renewal date.(47) Given that this formulary change probably affected a large number of people, we saw relatively few appeals to independent review.

One patient was moved to other medications but wanted Lipitor again. The reviewer recommended that the patient try Zocor for at least 30 days first.(48) In the other case, the patient's doctor said she had responded well to Lipitor. She tried Zocor as required by Aetna, then was asked to try two other drugs. "It seems onerous to force a patient to try two agents (Baycol and Lescol) that are well known to be less effective than either Lipitor or Zocor," wrote the reviewer when finally approving the Lipitor.(49) In these two cases, the independent review fullfilled its purpose by providing the patient an individualized (and independent) needs assessment when faced with formulary restrictions.

While Pfizer's Lipitor is one of the best-selling pharmaceutical drugs worldwide, it is newer than Merck's Zocor. Lipitor entered the market in 1997 and quickly became a popular cholesterol-lowering drug.(50) Lipitor and Zocor are both among the top 25 drugs used by state employees and teachers.(51)

The battle of the efficacy studies rages unabated between Lipitor and Zocor. Research on Zocor in 1994 prompted growth in the use of statins (cholesterol-lowering drugs), after a study showed that it could greatly a patient's risk of dying from a second heart attack.(52) A study presented at the 49th 0Scientific Session of the American College of Cardiology in March 2000 found that Zocor increased levels of both "good" cholesterol (HDL) and apolipoprotein more than Lipitor.(53) At the same time, a 1999 European study found Lipitor more effective than Zocor at lowering "bad" cholesterol.(54)

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Footnotes:

35 Independent Review Inc., IRO Decision Letter, Aetna, 7/20/2001.

36 Independent Review Inc., IRO Decision Letter, Aetna, 5/18/2001.

37 Independent Review Inc., IRO Decision Letter, IMS Managed Care, 6/5/2001.

38 Texas Medical Foundation, IRO Decision Letter, Aetna, 5/29/2001.

39 Texas Medical Foundation, IRO Decision Letter, Aetna, 7/10/2001.

40 Independent Review Inc., IRO Decision Letter, Aetna, 7/12/2001.

41 Texas Medical Foundation, IRO Decision Letter, Prudential, 5/31/2001.

42 Independent Review Inc., IRO Decision Letter, Aetna, 5/26/2001.

43 Independent Review Inc., IRO Decision Letter, Aetna, 7/20/2001.

44 Independent Review Inc., IRO Decision Letter, Aetna, 8/3/2001. Independent Review Inc., IRO Decision Letter, Aetna, 8/28/ 2001. Envoy, IRO Decision Letter, Aetna, 9/11/2001. Envoy, IRO Decision Letter, Aetna, 4/16/2001.

45 "FDA Mandates New Labels for Anti-fungals," Dermatology Times, June 1, 2001.

46 "Advisory for fungal drugs," FDA Consumer, July 1, 2001.

47 Aetna Lipitor Policy, www.aetna.com/products/rx/data/lipitorcpb.pdf. Download date, 3/21/2002.

48 Independent Review, IRO Decision Letter, Aetna, 8/27/2001.

49 Envoy, IRO Decision Letter, Aetna, 5/22/2001.

50 "Power play: Pfizer Inc.," Med Ad News, September 1, 2000.

51 Interagency Council on Pharaceuticals Bulk Purchasing, Public Meeting, 2/12/2002.

52 Gorman, Christine, "Are Statins Right for You," November 6, 2000, p. 102.

53 "First Study of Cholesterol Medicines at their Highest Doses Showed Zocor Raised Levels of Good Cholesterol and its Key Protein Significantly More than Lipitor," PR Newswire.

54 European Atheriosclerosis Society, "Lipitor More Effective than Zocor and Baycol for Lowering Cholesterol," May 27, 1999.


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