WASHINGTON, DC—some veterans advocates are accusing the Department of Veterans Affairs formulary and its administrative system of not being properly transparent, and of making it too difficult for VA physicians to prescribe non-formulary medications when necessary. Legislators and veterans groups report hearing from veterans whose physicians were unable to get access to the drugs they wanted to prescribe, and from physicians who have had to go through an impractically long process in order to get non-formulary drugs.

Formulary Complaints

At a House VA Health Subcommittee hearing on the topic last month, Rep. Michael Michaud (D -ME) said, “I have heard from veterans who have voiced their frustration with the VA national formulary as being too restrictive to the point that accessing appropriate drugs is a barrier. Some veterans have pointed to a flawed, subjective system for securing non-formulary drugs. For example, a veteran who is denied access to a non-formulary drug at one VA medical center may be approved in another medical center, which suggests that the decision may not be based entirely on clinical factors.”

Others have heard similar stories. Rick Weidman, executive policy director for the Vietnam Veterans of America, testified that veterans and physicians have approached his organization relating problematic situations. For example, instances where they were unable to access drugs, it took an inordinate amount of time to get access to non-formulary drugs, and where cost was cited as a factor. Weidman accused VA of practicing a policy of cost avoidance by trying to reduce front-end costs of care such as pharmaceutical expenditures. “We believe it is inappropriate to put cost management above proper clinical care,” Weidman declared. “Lack of proper medication at the proper time because it wasn’t on the formulary can lead to all kinds of health impacts that can cost [more].”

Weidman also noted that the process by which VA chooses drugs to include in its national formulary is a relatively closed one. He proposed that Congress either request the VA Secretary, or put forward legislation, to make the VA formulary process more like DoD’s, which is relatively transparent and includes more input from beneficiaries. DoD, he said, also includes more drugs on its formulary. VA has received complaints from servicemembers moving from DoD care to VA in instances where VA physicians cannot obtain medications those patients had access to previously through DoD.

A System That Works

VA officials, on the other hand, testified that they have heard quite the opposite from patients and physicians, and that the VA formulary process is sound. Just prior to last month’s hearing, J.D. Power and Associates released a report on pharmacy customer satisfaction that ranked VA’s pharmacy service. “We ranked third in J.D. Power’s customer ratio survey,” explained Michael Valentino, VA’s pharmacy chief. “Our physicians seem to be fairly happy with the process and their access to non-formulary drugs. And if we can believe J.D. Power, our patients are very happy as well.”

In response to the accusation that VA’s process is too secretive, Valentino countered that, “We have a fair amount of transparency.” The VA formulary is administered through the Pharmacy Benefits Management Office at the Hines, Illinois VAMC. While the PBM acts as the organizational entity overseeing the formulary, the VA Medical Advisory Panel and the VISN Pharmacist Executives Committee actively manage the formulary. The MAP provides clinical oversight of the process and is comprised of practicing VA physicians, PBM clinical pharmacists, and a physician from the Department of Defense. PBM pharmacists monitor the medical literature and draft evidence-based prescribing guidelines. Those guidelines are sent for peer review throughout VA before being presented to the MAP for and VPE for consideration. “The literature we develop is vetted extensively and sent far and wide for comment, and then posted on our web site,” Valentino explained.

As for the proposal to make VA’s formulary management system more like DoD’s, Valentino said he understood DoD had a beneficiary advisory panel that looks at formulary decisions after the executive advisory panel and that he would be happy to consider such a proposal for VA.

The idea that cost is a major factor in adding drugs to the formulary is untrue, Valentino added. “Cost is not factored in until the very end of the process. Safety and efficacy are our number one considerations.” He cited one example where VA chose a more expensive drug because it had more medical evidence supporting it over the alternatives. Lucentis, an anti-cancer drug approved by FDA for treatment of wet age-related macular degeneration, costs thousands of dollars per injection.Another drug,Avastin, has the same results but costs pennies. However,Avastin is approved only for treating cancer, and notAMD. VAwent with Lucentis because it was backed by FDA-supported evidence—a decision that was made several years ago and still stands today.

Valentino also testified that VA does not leave physicians or patients waiting for decisions on non-formulary medication requests. There is a 96-hour time limit for review of non-formulary requests. And if a non-formulary drug is needed immediately, it is given immediately.

There was some lag time, Valentino acknowledged, with the first wounded veterans being transferred from DoD care to VA care. In those cases, VA had to play catch-up in regards to available treatment and medication. “Early on we had some issues with veterans till on active duty and going to VA, coming to us with very complex [pain medication] requiring tubing [and other equipment]. It took us some time to get that equipment in.”

Problems Keeping Count

One area where Valentino agreed that VA needs improvement is in keeping track of VA medications within its pharmacy system. Arecently released VA Office of the Inspector General report of an audit of VA’s pharmacy inventory showed that many VA medical facilities could not accurately account for non-controlled drug inventories because of inadequate management practices, record keeping, and inaccurate pharmacy data. In an analysis of 2 of VA’s 7 consolidated mail outpatient pharmacies, OIG investigators found pill variances ranging between negative 3,100 and an excess of 192,000 pills.

The OIG recommended enforcing annual wall-to-wall inventories of pharmacy stock, developing better monitoring policies, and enforcing compliance with existing regulations. The VA agreed with all of the OIG’s recommendations. “We concurred with all of their recommendations. We have told people what we want them to do and developed a policy that is under review,” Valentino said. That is what VA is doing in the short-term. They’re also working with local network offices to come up with teams that will go out and review pharmacy inventory management at VA sites. “You really need to monitor everything if you want to have confidence in the process,” Valentino said.

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