Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-1980-IFC
Room 309-C
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the January 7, 1998 interim final rule, which implements a provision of the Balanced Budget Act of 1997. This rule specifies how, and under what circumstances, the Secretary of Health and Human Services can modify reimbursement levels for different items and services, including clinical laboratory services. Our specific comments follow:


Section 405.52 (g)(1)(ii) & (iii)

The interim rule states that HCFA or a carrier may determine the standard rules for calculating Part B payment amounts for a category of items or services that result in "grossly deficient or excessive amounts." We do not agree with this interpretation of the statute. The Balanced Budget Act limits the use of this discretionary authority to the Secretary of Health and Human Services. Therefore, carriers should not be granted this authority. Further, one of the key clinical laboratory changes in the balanced budget agreement was the movement towards more uniform Medicare policies. These provisions could result in greater diversity and inequities in payment policy.


Section 405.52 (3)(ii)

Carriers modifying their payment levels "must inform the affected suppliers and State Medicaid agencies of the factors it considered in determining and establishing the limit…and solicit comments." If carriers are, ultimately, given authority to make payment adjustments, then they should have to go through a rigorous notice of proposed change, review of received comments and publication of a final notice (including responding to public comments) as HCFA does. Although the interim rule alludes to this type of procedural process, it needs to be further defined in the regulation.

In addition, AACC recommends that a carriers formal notification to HCFA include both the comments they received, as well as their responses. We believe that HCFA should be fully informed of supplier views prior to approving a carrier’s modified payment level. Also, carriers should be required to provide "no less than 60 days for public comment on the proposed payment limit," as set forth for HCFA under (h)(3)(i)(E).’

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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