440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700

Date: Tue, 02 Oct 2007 08:44:34 -0700

05 00430 61 07100201

Ms. Lee Faleafine
Customer Representative
Division of Medicare Health Plans Operations
CMS Region 9
Centers for Medicare & Medicaid Services
90 7th Street Suite 5-300 (5W)
San Francisco, CA 94103 6706
Subject:   Statute Clinical Trial Self-referral

Dear Lee,

Last week on September 27, we received a call from Cathy Windfield-Jones with CMS. She suggested calling your office at 415 744 3617 to assist in resolving a payment issue with Kaiser. Millie has been treated for breast cancer at Kaiser in Walnut Creek, CA since 2002, and was referred for treatment at UCSF on a clinical trial beginning on 070130 (2007, January, 30).
Though not presented when the doctor made the referral on 070105 in August Millie began getting a lot of invoices, now over 100, from UCSF backdated for treatment in January that total over $4K for treatments prescribed by Kaiser and performed by UCSF. Annualized amount is $10K, nearly 10 times the amount of insurance premiums.
I met with UCSF's accounting rep, Bob Schwartz, on 070830. Bob indicated UCSF does not know the basis for their charges, except that Kaiser's Medicare unit calculates the amount UCSF bills Millie, and justification is based on Kaiser's determination that Millie can "self-refer" for participation in a clinical trial.
Our question to CMS is whether Medicare support for patients to "self-refer" to clinical trials, prohibits Kaiser from referring patients for treatment in clinical trials, as Kaiser has been doing in this case since 2002, shown by the study on 070830.

Please call me at 925 680 8947.

Rod Welch