Yesterday, Sens. Chuck Grassley, Max Baucus, Orrin Hatch, and John D. (JayRockefeller) asked the Inspector General for the Department of Health and HumanServices for guidance to address the legal concerns of drug makers who participate inpatient assistance programs. The Inspector General issued an opinion today.Comments from individual senators follow here.
“It's good to finally have this advisory opinion from the Inspector General. Thecompany who made the request now knows that its program to help Medicarebeneficiaries meets federal rules and requirements. I urge the Inspector General toprovide similar assurance to other companies quickly as the May 15 deadline is fastapproaching. Those companies also need to provide any additional information requested by the Inspector General in a timely way." -- Senator Chuck Grassley
“I'm glad the HHS Inspector General was able to advise one drug manufactureron how to continue its patient assistance program properly in conjunction with theMedicare drug benefit. I trust that other companies seeking advice and assistance willget timely help from the IG, so they can keep their programs going. It's good that thepharmaceutical manufacturer involved has found a way to continue providing thismuch-needed assistance, and I hope that others in the industry can do the same so thatfinancially needy Medicare beneficiaries can get the drugs they need." -- Senator MaxBaucus
“The Inspector General's office made a good start today by clarifying for onecompany the legal parameters for operating a PAP. But more needs to be done. In thecoming days, the Inspector General must give clear guidance to other drugmanufacturers and to the free clinics also awaiting a decision. Hundreds of thousandsof Medicare recipients are scared that they will not be able to afford the prescriptiondrugs they need. We must make sure that these programs are still there to help our seniors." -- Senator John D. (Jay) Rockefeller IV
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Monday, April 17, 2006
Senators seek continued assistance from drug companies for Medicare beneficiaries
WASHINGTON - Top health care policy makers in the U.S. Senate have askedfor prompt and definitive guidance from the government to help ensure that Medicarebeneficiaries with extraordinary needs can continue to access additional assistancefrom pharmaceutical drug makers even after signing up for the new Medicareprescription drug benefit.
At issue is the continued availability of pharmaceutical manufacturer patientassistance programs, known as PAPs. Sens. Chuck Grassley, Max Baucus, Orrin Hatchand John D. (Jay) Rockefeller IV have urged the Inspector General for the Departmentof Health and Human Services to make a clear statement as soon as possible addressingthe legal concerns of drug manufacturers so that the additional drug assistance thathelps so many individuals through these PAPs is not discontinued after May 15, thedeadline for Medicare beneficiaries to sign up for the new Medicare drug benefit.
“Clear-cut guidance is needed to help maintain the drug assistance that manyolder Americans rely on, and we've been working to get that guidance for several months," Grassley said. “These Medicare beneficiaries have extraordinary health careneeds."
“Many seniors simply wouldn't get the drugs they need without patientassistance programs, so it's important that the government quickly provide appropriateadvice on how these programs can mesh with the new Medicare drug benefit," said Baucus. “I believe it's possible to discourage Medicare fraud without discouraging drugmanufacturers from providing these vital programs, and I know the Inspector Generalwill seek to strike a balance that works."
“We have been pushing for a resolution on this issue since November," saidRockefeller. “We are less than a month away from having some drug companiesterminate these vital programs, and yet our seniors still have no assurance that they willbe able to get the prescription drugs they need from these programs. Nothing short ofan immediate and complete clarification of these rules is acceptable."
The text of the Senators' letter to the Inspector General follows here.
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April 17, 2006
Mr. Daniel R. Levinson, Inspector General Department of Health and Human Services Room 5541 Cohen Building
330 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Inspector General Levinson,
We are writing to express our support for the continued availability ofpharmaceutical manufacturer patient assistance programs (PAPs). As you know,manufacturer PAPs provide free or subsidized medications to thousands of individuals,including Medicare beneficiaries, who might not otherwise be able to afford theirprescription drugs. Many seniors and individuals with disabilities who participate inmanufacturer PAPs have chronic conditions. These beneficiaries must take veryexpensive prescription drugs - which often do not have generic drug equivalents - tomanage those conditions and to maintain their quality of life. Without assistance from aPAP, some Medicare beneficiaries may not otherwise be able to afford theirprescription drugs, even if they are enrolled in the new Medicare prescription drugbenefit.
We appreciate that your office issued the Special Advisory Bulletin on PatientAssistance Programs last November. The goal of this Bulletin was to clarify theapplicability of the federal anti-kickback statute to all PAPs, including those offered bypharmaceutical manufacturers. Unfortunately, it is our understanding that the Bulletinmay have had the opposite effect. As a result, several pharmaceutical manufacturershave indicated that they will discontinue their prescription assistance to Medicarebeneficiaries as of May 15.
Your office has achieved significant accomplishments in reducing waste, fraudand abuse in the Medicare Part A and Part B programs. We applaud the OIG's efforts inassisting, developing and implementing a comprehensive strategy to identify andprevent fraud, waste and abuse under Medicare Part D. Working with the Centers forMedicare and Medicaid Services (CMS), the Federal Bureau of Investigation (FBI) andprosecuting attorneys at the Department of Justice (DOJ), the OIG has recognized theimportance of protecting Medicare beneficiaries and taxpayers' dollars. That said, weare troubled that the OIG's Guidance may limit-albeit unintentionally-beneficiaryaccess to necessary medications. We are particularly concerned about the ongoingavailability of manufacturer PAPs for three groups of Medicare beneficiaries: 1)low-income beneficiaries of limited means who do not qualify for the low-incomesubsidy; 2) low-income beneficiaries between 135 percent and 150 percent of povertywho qualify for the low-income subsidy, but pay 15 percent coinsurance for theirprescriptions; and 3) higher-income beneficiaries with catastrophic prescription drugneeds who currently derive a significant benefit from participation in pharmaceuticalmanufacturer PAPs.
It is our understanding that some companies have requested advisory opinionsfrom the OIG regarding the legality of the specific design of their PAPs. Weunderstand that this process is iterative and that the OIG often must ask the requesterfor additional information. We hope, though, that the OIG will continue to work asexpeditiously as possible in responding to these requests, which may help mitigate thissituation. Again, we urge you to work to further clarify the legal guidance on themanufacturer PAPs as expeditiously as possible. We believe a resolution can beachieved that allows pharmaceutical manufacturers to continue providing much neededassistance to certain groups of Medicare beneficiaries in a manner that does not violatethe integrity of the Medicare program.
We thank you for your prompt attention to and consideration of this request.Because of the seriousness of this matter, we are instructing our staff to contact youroffice Monday to discuss this issue further.
Sincerely,
Charles E. Grassley Chairman
Max Baucus Ranking Minority Member
Orrin G. Hatch Chairman Health Care Subcommittee
John D. Rockefeller IV Ranking Minority Member Health Care Subcommittee
cc: Michael Leavitt, Secretary, Health & Human Services
Source: Ranking Member’s News
