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By most accounts, the Medicare Part D drug benefi t has been a smashing success.
The Centers for Medicare and Medicaid Services (CMS) reports that close to 23.9 million people had enrolled in Medicare prescription drug plans as of January, up from 22.5 million in June 2006.
Meanwhile, costs have been lower than expected. In January 2005, the Congressional Budget Offi ce estimated the net cost of the benefi t to the federal government to be $32.1 billion in 2006. By late last year, the 2006 cost projection had fallen to $31 billion. Monthly premiums for enrollees in 2007 are averaging $22, according to CMS, down about a dollar from last year and sharply below the initial forecasts of $37.
But what of the clinical benefi t of this new coverage for so many older Americans? "It probably has improved adherence and compliance," says David Nash, MD, chairman of the Department of Health Policy at Jefferson Medical College of Thomas Jefferson University in Philadelphia. "But I can't cite you any studies."
Indeed, CMS and private Medicare Advantage health plans are busy collecting data and crunching the numbers, but no reliable clinical results yet exist from the program, which went into effect Jan. 1, 2006. "It's really too early to start making analytic judgments," says Jim Turpin, Medicare Part D specialist for TMF Health Quality Institute, the Medicare quality-improvement organization (QIO) for Texas.
The QIO in each state is responsible for obtaining and analyzing data on adherence and persistence of patients on medications. TMF's investigation of 2006 data is due by the beginning of the fourth quarter of 2007, Turpin says.
IMPROVED ACCESS, ADHERENCE ENHANCED
"Clearly, Part D has done a couple of good things. It increased access, especially for lower-income people," says Nash. He adds that the benefit also has brought attention to the importance of medication adherence. "We're probably going to see greater intensity of drug therapy for Medicare patients," Nash says. "That's the access." However, he cautions that results are preliminary and that research is lacking.
As for compliance, just having coverage for drug spending ought to help individuals. "Historically, the assumption will be that compliance is better," says Joseph Addiego, MD, chief medical officer for Ovations, the senior division of UnitedHealth Group, and for Prescription Solutions, the health plan's pharmacy benefit manager (PBM).
Thomas Barsanti, MD, senior medical director for pharmaceutical manufacturer Pfizer, concurs, based on his experience with various state Medicaid programs, in which the mere existence of a prescription benefit has helped limit product switching by reining in patient out-of-pocket costs. "When there is forced switching going on, adherence goes down," Barsanti says.
But compliance and adherence are not the same as utilization. Ovations will be examining filling patterns to determine compliance. "If somebody's taking an anticoagulant after surgery, they should be taking it for four to five months. We look at how many fills they have to determine compliance," Addiego says.
That type of measurement works well for acute and short-term conditions, but Medicare Part D is an entirely different ballgame for patients with chronic diseases such as diabetes, obesity, and cardiovascular disease. For starters, Medicare Part A has long covered inpatient medications and Part B continues to pay for many infusion therapies delivered in ambulatory settings. In those cases, patients often do not have much choice regarding what drug they take.
Part D, however, requires physicians and patients to work within the confines of health plans' formularies. Medicare beneficiaries—particularly older ones who have not had private drug coverage for a number of years—may not be all that familiar with how tiered formularies work.
"The communication process to the beneficiary is a complicated one that we try to make as simple as possible," says UnitedHealth spokesman Dominick Washington. Health plans and QIOs also are providing resources for physicians to help their Medicare patients understand formularies, but that is something practitioners often don't have time to do.
"Most primary care docs don't really care what formularies patients are on," says Nash, a board-certified internist who is on the physician advisory committee of Cigna and a board member of the Disease Management Association of America. "And most don't know what drugs cost."
Pfizer's Barsanti recommends that physicians pay attention to factors such as cost, patient medication history, and comorbidities. "That discussion is best achieved between the physician and patient," Barsanti says. He further advises that physicians ask their patients to report back on how a particular drug is working and if costs suddenly change. (Costs may fluctuate quite a bit if Congress gives CMS the authority to negotiate with drug suppliers.)
If this sounds like disease management, that's because it is. CMS requires Medicare QIOs to plan quality-improvement projects around the Part D benefit. In Texas, TMF Health Quality Institute chose to focus on hyperlipidemia and schizophrenia among dual Medicare-Medicaid eligibles.
In this program, the QIO will analyze claims data to identify patients taking both statins and what Turpin calls "atypical antipsychotics." It will then offer educational materials to help patients stay on their drug therapies.
UnitedHealth's Ovations profiles beneficiaries based on medication history and spending on prescriptions, looking for higher-risk patients. "We focus on disease states," Addiego says. Since patients taking insulin likely have diabetes, the health plan will look to see if the same individuals also are on ACE inhibitors, as medical evidence recommends. If not, the Prescription Solutions PBM will raise the issue. "We intervene both proactively and reactively," Addiego says.
In some cases, Medicare Part D benefit providers require prior authorization before certain drugs are covered. That means that the patient must fail on an over-the-counter or lower-cost prescription treatment before the health plan will pay for a more expensive drug—a process CMS calls step therapy.
Each health plan, including CMS itself, sets pharmacotherapy algorithms that physicians must work through in prescribing drugs to Medicare beneficiaries. "This is difficult because it adds a significant administrative cost to their practice," Barsanti says. "It's almost impossible for [physicians] to keep track of all the algorithms."
Barsanti says that CMS is working to improve this process on a disease level so patients won't have to go through a progression of drug therapies before getting the right medication. In the meantime, he advises clinicians to take advantage of resources that QIOs and medical specialty societies offer and to work through such organizations to advocate for change in areas where algorithms are not working.
Office staff also can help streamline the authorization process. "I
would request the algorithm for a specific insurance plan," Barsanti
says. "That would help them kind of check off the boxes, knowing what a
specific insurer is going to request up front." 
Part D Plan Changes for 2007
A comparison of Part D plan formularies from 2006 to 2007 found the following results:
Stand-alone prescription drug plans (PDPs)
Medicare Advantage prescription drug plans (MA-PDPs)
Top Drugs for Seniors
Medicare compared the top 100 drugs in the 2007 and 2006 formularies that
seniors use in the top 10 enrollment plans in each PDP region. The
conclusions:
Source: Medicare Part D 2007 Formulary Changes Tip Sheet, CMS Pub. No. 11224-P, October 2006
Footnotes
Education materials from CMS are available for health care professionals in a PowerPoint and audio replay format. To view and hear the "Working With Plan Formularies: Transition Supplies, Prior Authorization, Quantity Limits, Step Therapy, and Exceptions" training session, go to www.cms.hhs.gov/MLNProducts/23_DrugCoverage.asp.
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