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Closing Loophole in Medicare Drug Coverage
August 9, 2007 • Volume 7, Issue 31Before Congress adjourned for its summer recess last week, the U.S. House of Representatives passed the Children’s Health and Medicare Protection Act, containing the most sweeping changes in the Medicare program since Congress created the prescription drug benefit in 2003. It would increase premium subsidies for people with Medicare whose incomes are low and provide free preventive medical care. The legislation would also expand the State Children’s Health Insurance Program (SCHIP) for millions of children of low-income families. But when the Senate also voted last week to continue SCHIP, its legislation left out any mention of people with Medicare. The two bills must be reconciled into one and then voted on again before it goes to the president for his signature.
The Medicare Rights Center urges Congress to ensure that the final bill includes all the Medicare improvements in the House bill, but there is one more Medicare change Congress should add. Neither bill closes a loophole in how the Bush administration runs the Medicare’s drug benefit. It enables insurance companies to deny coverage for drugs that have been proven to help an individual. As a new report from the Medicare Rights Center shows, this obstacle simply makes no sense.
When the officials running the Medicare program issued rules regulating the drug benefit, they prohibited coverage for drugs used to treat health problems that were not approved by the U.S. Food and Drug Administration (FDA). If the drug was prescribed for treatments not listed on the FDA label, drugs plans cannot cover these so-called “off-label” uses—with one exception. The drugs may be covered if they are used for an off-label treatment included in one of three medical reference guides (referred to as drug compendia) that document uses of medicine supported by several clinical studies and other medical literature.
Over 20 percent of the 500 most commonly prescribed drugs—about 145 million in 2001—are used for off-label treatments for cancer and HIV, pain management, mental health conditions, among other things. The drug compendia do not include all such uses for the drugs and updates are not updated fast enough.
So what does this mean? If you were using a drug for an off-label treatment that is not listed is any of the three compendia before you joined a Medicare private drug plan, it may not be covered by your Medicare private drug plan.
Ms. Q, an MRC client in Oregon, is in this predicament. She has diabetes and digestive problems. After trying several medications to control nausea without success, she was prescribed a drug used by patients after surgery or who receive chemotherapy. It finally worked, but her Medicare private drug plan will not cover it because the drug is not approved by the FDA for Ms. Q’s condition and is not listed in the drug compendia. It does not matter that Ms. Q is living proof that the drug is effective for her and has been for some time.
It also does not seem to matter that Medicare’s very limited coverage for off-label prescriptions under Part D (Medicare’s outpatient prescription drug benefit) does not apply to drugs covered under Medicare Part B rules (Part B covers drugs that are administered in a doctor’s office). It also does not apply to many off-label treatments covered by Medicaid, the government program for low-income families. In addition, the three drug compendia named in the Medicare Part D regulations are different from the compendia referenced in Medicare Part B regulations (medical insurance).
As a result, people who received drugs for off-label treatments while they were in Medicaid or an employer-sponsored drug plan may not be able to get them in a Medicare private drug plan.
Ms. Q’s drug costs more than $7,500 a month. Because she cannot afford to pay for it herself, Oregon’s Medicaid program is providing it while she is appealing her drug plan’s denial of coverage. The state will not continue to cover it if she loses her appeal, which is likely given Medicare’s Part D coverage regulations.
If she cannot take her medicine, she could end up in the hospital. When she gets sick, at least she will not have to worry about who will pay the hospital bill. Medicare will pay for the expensive hospital visits even though they may have been avoided by taking her doctor’s prescription.
That does not make a lot of sense, but those are the rules.
The Medicare Rights Center is urging Congress to require coverage of medically necessary and effective off-label prescription drug treatments. Coverage should not be limited to only those off-label uses included in one of the three medical compendia. A drug’s off-label use should be covered if it has been reviewed in peer-reviewed medical journals or has been effective for the patient.
Medical Record
“Morris Hilton, 42, whose head was crushed when his apartment collapsed around him during a 1997 tornado in Chattanooga, Tenn., is among the patient stories published in the [Medicare Rights Center’s] report. He suffers from traumatic brain syndrome and says he experiences debilitating headaches almost daily. … ‘They're saying to me, “You're going to have pain all the time, and we're not going to pay for your medication, although if you had cancer pain, we would,” ’ Hilton says. ‘What's the difference?’” (“‘Off-label’ Drugs Denied to Patients in Medicare D,” Julie Appleby, USA Today, August 2, 2007).
“Using data from a nationally representative survey of office-based physicians, we found that about 21% of all estimated uses for commonly prescribed medications were off-label. ... Many of the observed off-label drug mentions, particularly among medications frequently used off-label, represent a logical extension of the FDA-approved indication. For example, certain unapproved uses of antibiotics could be justified by laboratory studies demonstrating that the disease-causing organism responds to drug therapy. Albuterol, which is approved to treat asthma, is a clinically accepted off-label therapy for physiologically similar chronic obstructive pulmonary disease” (“Off-label Prescribing Among Office-Based Physicians,” David C. Radley, MPH; Stan N. Finkelstein, MD; Randall S. Stafford, MD, PhD, Archives of Internal Medicine, May 8, 2006).
“Ms. L has been diagnosed with a rare form of ovarian cancer. In order to prevent excessive bleeding and tumor growth, she was being kept alive with a drug that is FDA-approved to treat infertility. Before the start of the Medicare Part D, Ms. L paid $40 a month through her retiree insurance for this drug, which has a retail cost of over $30,000 a year. When Part D was implemented, Ms. L’s retiree insurance eliminated its prescription coverage and required all of its members to enroll in Part D. Ms. L’s Part D plan proceeded to deny coverage for her prescription, deeming it ‘off-label.’ Despite its medical necessity—attested to by her doctor—in ensuring Ms. L’s health, and despite medical literature overwhelmingly supporting Ms. L’s use of the drug, she was unable to obtain coverage through either of her drug plans” (“Off-Base: The Exclusion of Off-label Prescriptions from Medicare Part D Coverage,” Medicare Rights Center, August 2007).
* * * *Medicare Part D Appeals Help for Advocates is here!
MRC’s new “Medicare Part D Appeals: An advocate’s manual to navigating the Medicare private drug plan appeals process” offers an easy-to-understand, comprehensive overview of the entire appeals process, including real-life case examples, a glossary of important appeals terms, a sample protocol for advocates, and links to important resources.
Register for a FREE copy of this great resource.
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Medicare Part D Monitoring Project
The Medicare Rights Center (MRC) would like to hear about your experience, or that of someone you know, enrolled in a Medicare private drug plan. With information about what the issues are with Medicare Part D, we will be able to demand that those problems be fixed.
Submit your story at http://www.medicarerights.org/partdstories.html.
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