LETTER FROM THE AUA JULY 24, 2000

AMERICAN UROLOGICAL ASSOCIATION, INC
1120 North Charles Street
Baltimore, Maryland 21201-5559
Phone 410/727/1100
E-mail: aua@auanet.org
Web site: www.auanet.org


July 24, 2000

Mr. Terrence Kay
Director
Division of Practitioner and Ambulatory Care
Health Care Financing Administration
7500 Security Boulevard
Central Building
MS-C4-01 -17
Baltimore, MD 21244-1850

Dear Mr. Kay:

The American Urological Association is concerned that Medicare beneficiaries may have a problem accessing lithotripsy services for the treatment of kidney stones in the very near future. I share this with you in the hopes that the Health Care Financing Administration (HCFA) will take action to prevent this problem, which is related to the imminent release of the final rule implementing the physician self-referral (Stark) law. As you know, if the Stark rules are finalized as proposed, physicians will be prohibited from referring their Medicare patients to a lithotripsy facility in which they have a financial interest.

While we have reason to believe HCFA may write an exception for lithotripsy into the rule, we realize that it is prudent to have a contingency plan in case the exception is not granted. Otherwise, beneficiaries could be lost in the shuffle as physicians scramble to understand the implications of the Stark rules and to determine how to ensure compliance.

Although lithotripsy services were initially performed in a hospital inpatient setting, many hospitals did not have the financial resources required to purchase lithotriptors. They thought it was too risky to invest $1-2 million for this new technology in an unproven market. So, in order to offer this treatment option to their patients, urologists began to pool and risk their own resources to finance the 70 substantial capital costs required to obtain and operate a lithotriptor. In fact, according to the 1999 AUAIGallup survey of practicing urologists, 40 percent of urologists have a financial interest in a free-standing lithotripsy unit.

Therefore, if lithotripsy is not granted an exception in the final rule, and urologists with ownership interests in lithotriptors are not able to treat Medicare patients at that facility, they will be forced to refer these patients to a different facility or to
divest their interest. However, since Medicare patients only make up about ten percent of lithotripsy patients, some urologists may not divest, but will decide to refer their Medicare patients elsewhere. This will almost certainly lead to disruptions in patient access-particularly in rural areas-by forcing patients to travel to the next closest non-urologist owned lithotriptor, which may be quite a distance away. In some states, since there are no lithotriptors not owned by urologists, patients would potentially have to leave the state to receive treatment.

This situation is compounded by the fact that an ambulatory surgical center (ASC) facility fee for CPT code 50590 - Lithotripsy, extra corporeal shock wave (ESWL), will probably not go into effect until April 2001. If a facility fee payment for ESWL was allowed in an ASC, beneficiaries would have an additional option for treatment. Therefore, much of the access problem could be avoided if HCFA would allow immediate implementation of the June 12, 1998 proposed ambulatory surgical center (ASC) facility fee of $2,107 for ESWL.

Although we understand that the final rule with changes to the ASC payment system is tentatively scheduled for April 2001, waiting until next year to implement an ASC facility fee for ESWL could cause an interruption in service to Medicare beneficiaries. For example, if the Stark II final rule goes into effect in October 2000 and the ASC final rule goes into effect in April 2001, how will Medicare beneficiaries be affected during these six months?

In this case-because ASCs are exempt from Stark law-allowing an ASC facility fee for ESWL in advance of the final rule would be in the best interest of Medicare beneficiaries. And, due to the unique circumstances surrounding payment for lithotripsy services in an ASC, we believe HCFA could allow facility fee payments for this procedure prior to release of the final rule. As you know, a final ASC facility fee for ESWL has been delayed for many years. This delay is particularly troublesome in light of the relationship between the ASC payment regulation and the Stark regulation.

When HCFA published its December 31, 1991 final notice which added ESWL to the list of ASC covered procedures, the American Lithotripsy Society (ALS) filed a lawsuit challenging HCFA's determination that ESWL is a surgical procedure under the ASC benefit and questioning the facility fee established by HCFA. The court decision upheld HCFA's classification of ESWL as a surgical procedure, but postponed implementation of the lithotripsy facility fee pending further review of the rate-setting issue.

Therefore, while ESWL does not have an established payment rate, it is technically payment rate #9 on the ASC list (see sheet below). Furthermore, although determination of a facility fee for ESWL was delayed in the past due to the ALS court case, HCFA's recent decisions to delay publication of a final rule were due to its own Y2K computer concerns.

Consequently, it is important for HCFA to consider how the timing of the Stark and ASC rules will affect Medicare beneficiary access to this important service which treats a painful condition and to institute a contingency plan to ensure that service to beneficiaries is not interrupted. We think the easiest and best plan would be to allow immediate payment of the facility fee for ESWL performed in an ASC.

Thank you for considering our comments; we look forward to discussing this further. If you have any questions, please contact Mr. Scott Reid, Government Relations Manager, at 410-223- 4324.

Irwin N. Frank, M.D., FACS
President
American Urological Association

cc: American Lithotripsy Society

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American Lithotripsy Society
305 Second Avenue, Suite 200
Waltham, Massachusetts 02451
Telephone: (781) 895-9098
Fax: (781) 895-9088
email:
als@lithotripsy.org


ALS website developed
& maintained by
Sigsby Communications

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 


American Lithotripsy Society
305 Second Avenue, Suite 200
Waltham, Massachusetts 02451
Telephone: (781) 895-9098
Fax: (781) 895-9088
email:
als@lithotripsy.org


ALS website developed
& maintained by
Sigsby Communications