October 13,2005

Chairman Grassley says project to help cancer patients falls short, must be fixed

WASHINGTON — Sen. Chuck Grassley said a government-sponsored project that issupposed to help cancer patients by collecting information about the side effects of chemotherapyhas failed to benefit patients, even while directly charging patients whose physicians participatein the program and depleting Medicare program dollars.

Grassley said Medicare officials need to find a more effective way to improve the quality of care available to cancer patients.

Grassley said he based his call to revamp this particular effort on an evaluation herecently requested from the Inspector General for the Department of Health and Human Services.In preliminary findings the Inspector General reported, “it appears that assessing chemotherapypatients’ levels of nausea and/or vomiting, pain, and fatigue was already part of the routine careof chemotherapy patients prior to the demonstration.” The Inspector General also found that theproject’s haphazard data collection process produced unreliable or incomplete results.

The project, “Demonstration of Improved Quality of Care for Cancer Patients UndergoingChemotherapy,” cost cancer patients $22 million out-of-pocket during the first six months of thisyear. It is estimated that total costs in 2005 to patients and the Medicare program will be $300million.

Grassley spelled out his concerns and urged the demonstration project to be fixed orresources to be redirected in a letter sent today to President Bush. Grassley also shared the newfindings of the Inspector General with other senators in a Dear Colleague letter. The text of bothletters follows this news release. The Inspector General’s report to Grassley is attached in a pdffile. Also attached is a June 2005 letter from 39 senators to President Bush in support of thedemonstration project as currently designed.

Grassley is Chairman of the Senate Committee on Finance, which is responsible foroversight of the Medicare program, in addition to Medicare legislation.

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October 13, 2005

President Bush
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500

Dear Mr. President:

I am writing to express great concern about the cost of a Centers for Medicare andMedicaid Services' (CMS) demonstration, "Demonstration of Improved Quality of Care forCancer Patients Undergoing Chemotherapy, " to the Medicare program and, more importantly, toits beneficiaries. CMS's demonstration may be failing the patients it was intended to serve. Itappears that additional money is coming out of the Medicare program and cancer patients'pockets without any new benefit to the patients.

Under this demonstration, CMS provides a $130 allowance each time a chemotherapyprovider reports on a Medicare patient's levels of nausea and/or vomiting, pain, and fatigue-threeconditions commonly experienced as symptoms of cancer or side effects of cancer treatment.This demonstration project is open to all office-based chemotherapy providers and requires noformal enrollment. Medicare beneficiaries are liable for a co-payment of $26 each time theirprovider bills the demonstration codes in conjunction with their chemotherapy. Beneficiaryliability for the demonstration during the first 6 months of 2005 was $22 million. CMS estimatesthat Medicare and its beneficiaries will spend $300 million under this demonstration project in2005.

On August 12, 2005, I requested the Office of Inspector General (OIG), Department ofHealth and Human Services to evaluate the economy and effectiveness of this demonstration.Attached is the OIG's response for your consideration. See Attachment 1. I am extremelytroubled by the OIG's preliminary findings regarding the project. According to the OIG, "itappears that assessing chemotherapy patients' levels of nausea and/or vomiting, pain, and fatiguewas already part of the routine care of chemotherapy patients prior to the demonstration." It'sunnecessary and fiscally irresponsible to require patients to pay for services that are alreadycovered as part of their routine care.

In addition, the oncologists and researchers interviewed by the OIG stated that thepurpose of the assessments is to determine suitable interventions for the patients' symptoms ofnausea and/or vomiting, pain, or fatigue. Yet, the OIG found that the demonstration does notcollect data on the interventions used by oncologists to treat the symptoms, thereby limiting theusefulness of the demonstration data. Furthermore, because CMS is not mandating a specificapproach to data collection, the OIG found that oncology practices have used different methodsfor conducting the demonstration assessments, raising questions about the reliability of the datasubmitted to CMS.

On June 29, 2005, 39 Senators signed a letter to you supporting an extension of CMS'sdemonstration through December 2006. In that letter, they stated, "Our shared goal should be towork together to ensure that all Americans have access to high-quality, affordable, and accessiblecancer care." See Attachment 2. I believe that is an important goal, but we will not reach it byextending the status quo. It is critical that problems with the current demonstration be addressedquickly to ensure that public funds and patients' out-of-pocket expenses are spent effectively andefficiently. In particular, I ask that CMS work with the cancer community and other relevantstakeholders to identify ways to use money from the Medicare program and its beneficiaries toimprove both quality and outcomes of care for cancer patients and achieve value for moneyspent.

Sincerely,

Charles E. Grassley
United States Senator
Chairman, Committee on Finance

cc: The Honorable Michael O. Leavitt
The Honorable Daniel R. Levinson
The Honorable Mark McClellan

Attachments - 2

October 13, 2005

Dear Colleague:

I am bringing to your attention issues and concerns that have been identified by the Officeof Inspector General (OIG), Department of Health and Human Services regarding a one-yeardemonstration that was implemented by the Centers for Medicare and Medicaid Services (CMS)on January 1, 2005. Under this demonstration, chemotherapy providers are reimbursed $130each time they report on a Medicare patient's chemotherapy symptoms. Medicare beneficiariesare liable for a 20 percent co-payment of $26 every time their provider bills the demonstrationcodes. According to the OIG, beneficiary liability during the first 6 months of the demonstrationwas $22 million. CMS estimates that Medicare and its beneficiaries will spend $300 million in2005.

In August, I requested that the OIG conduct an evaluation of this demonstration. OnSeptember 8, 2005, the OIG responded with its preliminary findings, which I have attached foryour consideration. I believe you will be as troubled as I am by these findings, which include thefollowing:

Prior to the implementation of CMS's demonstration, chemotherapy providers were alreadyassessing their patients' levels of nausea and/or vomiting, pain, and fatigue as part of routine care.Thus, these providers are being paid $130 to simply forward the data that is already collectedduring a routine office visit.

The purpose of assessing patients' levels of nausea and/or vomiting, pain, and fatigue is todetermine suitable treatments for these symptoms; however, data on what treatments providersare using to address the symptoms are not being collected by CMS. Thus, the usefulness of thedemonstration data may be limited.

Oncology practices are using different methods to assess patients' symptoms, which putsthe reliability of the data they are collecting in question.

Attached is my letter to the President requesting that problems with the demonstration beaddressed quickly. I am also asking CMS to find ways to use the money from Medicare and itsbeneficiary to improve the quality of care for cancer patients.

Sincerely,

Charles E. Grassley
Chairman, Committee on Finance

Attachments - 2