Mr. Terrence Kay
Division of Practitioner and Ambulatory Care
Health Care Financing Administration
7500 Security Boulevard
Central Building
Baltimore, MD 21244-1850

Re: Ambulatory Surgery Center Rate for ESWL

Dear Mr. Kay:

The American Lithotripsy Society ("ALS") is the primary spokesman for the lithotripsy industry in the United States. We are writing concerning the letter dated July 24, 2000 just sent by the American Urological Association ("AUA") concerning Medicare reimbursement for lithotripsy under proposed APC 524 and the impending Stark regulations. We have no doubt as to the good faith of the AUA and share deeply their concern as to the access problems Medicare beneficiaries may face if the Health Care Financing Administration ("HCFA") finalizes the Stark II regulations in a manner which adversely affects the ability of urologists to treat their own patients on their own lithotripsy machines. However, the AUA's unfortunate linkage of the Stark issue with the Ambulatory Surgery Center ("ASC") payment rate is misguided and should be rejected.
First, as we stated in our comments to the proposed Stark II regulations, Stark II was never intended to apply to lithotripsy provided "under arrangement" with a hospital [See Attachment A]. Lithotripsy is not a designated health service under the Stark law, and would not be an issue, but for the current method in which HCFA pays for lithotripsy (i.e., only to or through a hospital).
Second, as we addressed in our comments to the ASC proposed regulations, the payment rate for lithotripsy of $2,107 is inadequate to cover the costs of the procedure [See Attachment B]. The AUA itself recognized the inadequacy of the rate and of HCFA's failure to base its rate on an adequate cost study [See Attachment C]. If this insufficient rate were implemented, it would further threaten beneficiary access as many facilities will not be able to afford to offer lithotripsy to Medicare beneficiaries at a rate below cost.
In addition, the proposed ASC rate, in our judgment, would be unlawful if adopted as proposed and especially if adopted prior to publication of the final regulations including a detailed discussion and explanation of the process and data used to set a payment rate for lithotripsy.
We can only wonder at the AUA's suggestion that the 1991 proposed rule be used as a basis for implementing the 1998 proposed rate. The 1991 proposal is still the subject of a federal court injunction and will remain so pending HCFA's final adoption of a rate, which comports with the ASC statute and the Administrative Procedure Act.
The ALS would welcome any opportunity to work with HCFA constructively to avoid any interruption of access to lithotripsy. Well over half of the access now broadly enjoyed by the Medicare population is supplied by physician-owned lithotripsy facilities. The ALS will continue its unwavering support of the right of Medicare beneficiaries to be treated by the best doctors, at the best facilities. ALS will also continue to defend what it believes is the unquestioned right of urologists to treat their patients at their own facilities.
The obvious solution is to finalize the Stark II regulations in a manner consistent with congressional intent and separately adopt an ASC final regulation, which provides an adequate reimbursement rate in full compliance with the standards Congress has set forth. We urge HCFA not to link two unrelated proposed regulations which, if finalized as proposed, would result in an insufficient payment rate, further jeopardizing access to this invaluable procedure, and an agency action inconsistent with Congress' statutory mandates and the Administrative Procedure Act.

Very truly yours,

Paul W. F. Coughlin, M.D.

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For additional information contact, Wesley E. Harrington, CAE, Executive Director of ALS at American Lithotripsy Society, 305 Second Avenue, Suite 200
Waltham, Massachusetts 02451
Telephone: (781) 895-9098
Fax: (781) 895-9088


American Lithotripsy Society
305 Second Avenue, Suite 200
Waltham, Massachusetts 02451
Telephone: (781) 895-9098
Fax: (781) 895-9088

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