Health Care Financing Administration
Entitlement, Enrollment & Protections Group, CBS
Mail Stop S2-01-23
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the Health Care Financing Administration’s (HCFA’s) draft Medicare transmittal notice 7310, "Limitations of Beneficiaries’ Liability – Advance Beneficiary Notices. Although we agree with HCFA’s objective—to provide patients with complete information about their potential financial responsibilities—we believe the ABN standards need to be more flexible, both in design and information requirements.

HCFA states that, in general, an ABN agreement consists of: (1) ABN language; (2) Beneficiary Agreement language; and (3) Beneficiary Refusal language. In addition, a "cautions" feature, outlining patient instructions, must be included in the ABN. Once the patient signs and dates the ABN—either agreeing or refusing to pay for services not paid by Medicare—the physician must provide the patient a copy of the ABN. Also, all non-selected items on a checklist, such as the laboratory tests not ordered, must be crossed out. We believe this process needs to be streamlined. Physicians will not use ABNs, nor will patients willingly participate, if the process is too cumbersome and time-consuming. And we believe that this process is both.

Most laboratories, in designing their ABNs, will seek to incorporate this agreement into their test requisition form. Since this form is often a single page, there is limited space for information. AACC believes that laboratories taking this approach should prominently display the ABN language on the requisition form, as well as provide a place for the beneficiary signature. We do not believe, however, that it is necessary to have a location reserved for the patient’s signature if they choose to decline a service. Such information (refusing a laboratory test) should be noted in the patient’s chart, not on the requisition form.

In addition, we do not believe that the physician (or the patient) should have to draw a line through all non-selected services or tests. This just extends the patient’s visit unnecessarily, while placing yet another administrative burden on the physician. There is no benefit, either to the laboratory or HCFA, by having a line drawn through these tests. Further, the "cautions" information listed in the draft notice is repetitive and, therefore, unnecessary. It repeats much of what is already stated in the ABN. We believe that ABNs should provide patients with the essential information they need to know, such as the ABN notice, a rationale as to why Medicare may not pay for the service and a place for their signature, and not confuse the issue with redundant or unnecessary information.

We are also concerned about a statement made by HCFA (A.iii. Last line), which asserts that "the beneficiary, of course, always has the right to a Medicare determination and the claim must be filed with Medicare." What if the laboratory already knows that Medicare does not reimburse for that service? Will it have to submit a bill anyway? Laboratories are not supposed to seek payment from Medicare for services not covered by the program. Also, what if the carrier pays the laboratory in error? It would appear that this provision might expose laboratories to potential fraud and abuse violations, as well as unnecessary costs. AACC requests that you either delete this requirement or further clarify the intent of this provision.

Similarly, section D subsection ii states that "physicians/suppliers are not required by Medicare program requirements to give ABNs to Medicare beneficiaries." What happens if a physician seeks an accommodation with the laboratory, such as offering to refer testing to the laboratory in exchange for not requesting ABNs from his/her patients? Isn’t such an arrangement a violation of HHS’s anti-kickback provisions? We request that HCFA provide clarification on this matter before such arrangements occur.

Also, are computerized ABNs acceptable? This type of ABN could be personalized to include only the information pertaining to a particular patient. For example, only the tests ordered would be included on the form—thus eliminating the need to cross out non-selected tests. In addition, the health care supplier would include either the Beneficiary Agreement or Beneficiary Refusal language, not both, depending on the patient’s decision. We recommend that HCFA address this issue in a future transmittal notice.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Manager, Government Affairs, at (202) 835-8721.



Stephen Kahn, PhD, DABCC


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