Specialty Pharmacy

Transplant Experts Address Problems Related to Part D Versus Part B

Reprinted from the September 2006 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

More than mid-way through 2006, confusion still reigns regarding Medicare Part B versus Part D coverage as it applies to transplant patients. Four experts offered opinions on what is happening in that area this year, what the future may hold and what people can do about current and future issues in an Aug. 17 audioconference sponsored by Transplant News titled "The Impact of Medicare Part D on Transplant Recipients."

Brad Kile, Ph.D., senior associate of consultant Dumbarton Group & Associates, LLC, started by mentioning some areas of the 2003 Medicare reform law that he thinks will change either later this year or in 2007, such as the late-enrollment penalty, the "donut hole" coverage gap and numerous "misaligned incentives" involving plans, pharmacies and states.

Serena Vlaicu, M.D., senior associate for Dumbarton Group & Associates, broke down Parts A, B and D when it comes to Medicare drug coverage. With immunosuppressants, she said, determining coverage is not as easy as it may be for other drugs. "These drugs are covered under Part B, for beneficiaries who received a Medicare-covered transplant, or they're covered under Part D for all other uses, which makes it confusing because the plan is often rejecting the coverage, saying that this should be B without even asking if the transplant was a Medicare-covered transplant," she said.

Vlaicu also noted:

• Oral anti-cancer drugs are covered under B when used for cancer treatment only if the active substance is the same as the one in injectables that would be covered under B.
• Oral anti-emetics are covered under B when used as a full replacement for IV anti-emetics and when used within 48 hours of chemotherapy.
• Erythropoietin is covered under B when used to treat anemia in people undergoing dialysis and "may also be covered under B for conditions other than dialysis if it's furnished incident to a physician's services," she said.
• Vaccines such as flu and hepatitis B are covered under B for high-risk beneficiaries.

"These are really confusing cases," said Vlaicu. "Although there is specific guidance out there, Part D plans are not always forthcoming, and most of them have not put systems in place that would allow for an easier understanding of either coverage being B or D, and they're just refusing coverage on the basis that a drug could be Part B." She noted that CMS encourages plans to use prior authorization (PA). And pursuant to March guidance by CMS, stand-alone Prescription Drug Plans (PDPs) can rely on information that physicians write on prescriptions that indicates B or D coverage. Based on discussions with CMS, she said, at least one large health plan is now taking phone diagnoses from retail pharmacists that specify whether the coverage is B or D. She did not identify the plan. Beneficiaries and providers can also request formulary exceptions, and then plans can offer coverage determinations on particular medications, she noted.

Beth Witten, who is the Medicare modernization program manager for the National Kidney Foundation, spoke about the Kidney Medicare Drugs Awareness and Education Initiative. The program has 35 member organizations and educates patients and professionals on Part D through a variety of methods, with information for kidney transplant recipients. The foundation's Web site is www.kidneydrugcoverage.org.

Witten cited United States Renal Data System information showing approximately 128,000 people have functioning transplants; of those, approximately 74,000 were Part D eligible. She said that although her organization had asked CMS, she did not know how many of these have actually signed up for the drug benefit. According to the American Society of Nephrology, 70% of end-stage renal disease patients in Part D will reach the donut hole (which in 2005 is between $2,250 and $5,100 of total drug expenses), and 39% could get to the catastrophic coverage that starts after $5,100.

Immunosuppressants under Part D are in a category, said Witten, that is supposed to include substantially all of the drugs available. However, not every brand-name drug is covered, and not every dose is covered. She added that a little-known fact is "Part D plans do not have to pay for Part B drugs if the person could have had Part B coverage but chose not to." Also, if a transplant patient was enrolled in Part A at the beginning of the month of the transplant (this can be backdated for 12 months to meet that criterion) and had the transplant in a Medicare-approved facility, the immunosuppressants would be covered under Part B. If they were not eligible for Part A at the time, the immunosuppressants would be covered under Part D, according to Witten.

A Part D plan can require PA or step therapy only for new transplant recipients, not those already stabilized on a formulary drug, said Witten. Plans cannot ask those patients to get PA. According to Witten, plans that stop covering a drug must give a 90-day notice or 90-day supply of the drug unless the coverage is halted because FDA stops sales of the drug for safety reasons.

Although there are still some issues with people getting drugs, she said that they seem to be lessening. The biggest issue, asserted Witten, is the confusion over Parts B and D.

Another issue that Witten addressed in the question-and-answer period was that of patient costs and how to deal with reimbursement. She contended that Medicaid should count Part D expenses toward patient spend-downs. She added that in Kansas, using the Freedom of Information Act, she got the composite rates for all of that state's clinics and forwarded the information to Medicaid, which then allowed dialysis patients to count the cost of the composite rate toward the spend-down. Most people are going to have the same deductible, she said, so the industry should push to start counting this so that transplant patients can continue receiving services.

Professor Terms System 'Catastrophe'

Amy Friedman, M.D., associate professor of surgery at Yale University School of Medicine, admitted that she is "extraordinarily confused" about how to get her patients' medications, and that she believes the "system is a catastrophe."

She noted that kidney transplant patients are on an average of 10 medications that cannot be interrupted without risk to the patient. Also, even without the financial considerations, medication adherence is an enormous problem. If you add in the financial aspects, there is an "enormous amount of confusion resulting in problems," she maintained.

Before Part D, she said, "52 patients came to us with problems getting medications." Problems ranged from lost medications and pharmacies denying prescriptions. To solve these problems took her facility an average of 25 days. Based on those experiences, she said, "it gives me great fear in wondering what's happening to the majority of transplant patients out there who aren't fortunate enough to be working with a local transplant center and don't feel necessarily comfortable enough to come forward saying that they have these problems and really don't know what to do. Patients can't handle this system on their own. It's far too confusing," she contended.

Beyond that, Friedman said that she doesn't have time to solve these problems, as she must be taking care of patients and performing operations. And her facility, she noted, isn't being reimbursed for the work done to solve these problems.

Since the implementation of Part D, Friedman said, the problems "have only gotten worse. We really are in a crisis."

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