Department of Health and Human Services
Health Care Financing Administration
Room 309-G (HCFA-1027-IFC)
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 June 26, 1998 interim final rule implementing the Medicare + Choice (M+C) program. We agree that Medicare beneficiaries should have greater choice in health care plans, so that they can select a plan that more closely meets their individual needs.

422.114 Access to services under an M+C private fee-for-service plan

HCFA states that M+C fee-for-service plans must permit enrollees to obtain services from any entity that is authorized to provide services under Medicare Part A and Part B and agrees to provide services under the terms of the plan. AACC supports the adoption of the any-willing-provider approach for providing services under a fee-for-service plan.

422.152 (b)(2) Quality assessment and performance improvement program

Managed care plans are required to conduct performance improvement projects that "achieve, through ongoing measurement and intervention, demonstrable and sustained improvement in significant aspects of clinical care and non-clinical care areas that can be expected to have a favorable effect on health outcomes and enrollee satisfaction." AACC recommends that HCFA encourage plans to work with their contracted providers, as well as other health care professionals and associations, in developing, performing and evaluating these performance improvement projects.

422.152 (b)(4) Quality assessment and performance improvement program

AACC also urges HCFA to aggressively monitor whether health care plans and their providers are adequately utilizing needed medical services. We are concerned that some providers will offer an unjustifiably low bid in order to gain entrance to a plan—forcing them to cut corners to stay profitable and possibly jeopardizing the quality of their services. AACC recommends that HCFA closely monitor utilization trends, the quality of services provided and the reimbursement amounts specified in capitated contracts. It is important that HCFA ensure that plans and providers not compromise the quality of services provided to their patients.

422.152 (c)(1) Quality assessment and performance improvement program

M+C organizations are required to measure their performance, using standard measures required by HCFA, and report their findings to HCFA. We believe that such organizations should publish (or at least make available upon request) their performance measurement reports. Therefore, we recommend that

HCFA insert the following after the first sentence in (c)(1): "Performance reports must be made available upon written request of any person, or, alternatively, by posting it on the organization’s website. Such reports must be provided or posted no later than 30 days following submission to HCFA."

422.152 (d)(5) Quality assessment and performance improvement program

Laboratory testing plays an important role in the diagnosis, treatment and monitoring of human health. Thus, AACC recommends that the plans’ performance improvement projects should include studies of laboratory services, including patient access to testing, quality of the testing and appropriate utilization of the services. This can be accomplished by adding a new provision, (d)(1)(v), which reads "Laboratory and other diagnostic studies." And, we recommend that HCFA require the plan share this performance information with participating laboratories.

422.152 (e)(3) Quality assessment and performance improvement program

This provision states that "if the organization uses written protocols for utilization review, the organization must…" AACC recommends that this provision be modified to read: "The organization must use written protocols for utilization review…" We also believe that a time requirement should be established. Therefore, we suggest that you insert the following language after 422.152(e)(3)(ii): "(iii) Provide its utilization review findings to enrollees and providers of services not less frequently than once each calendar year, either by furnishing a written report or by posting such findings on the organization’s website."

422.154 External review

HCFA requires that each M+C organization must, for each M+C plan it operates, have an agreement with an independent quality review and improvement organization approved by HCFA. AACC supports this requirement. We believe that outside quality assurance organizations, such as the National Committee for Quality Assurance, are necessary to (1) ensure plan integrity and (2) develop the necessary measurements for evaluating plan performance. AACC does recommend, however, that HCFA verify that each outside review organization has performance indicators for each component of the health care delivery system, including laboratory testing.

422.214 Special rules for services furnished by non-contract providers

HCFA states that a non-contract provider, which performs a service for a patient within an M+C plan, would be reimbursed at the original Medicare rate for that service. However, HCFA does not address how the non-contract provider will be reimbursed if it is a service not covered by Medicare. We recommend that you add a new subparagraph 422.214(a)(3): "Notwithstanding paragraphs (a)(1) and (a)(2) of this section, no M+C coordinated care plan may deny payment to a provider based on medical necessity considerations nor the failure of the provider to obtain a signed Advanced Beneficiary Notice.

422.501 General provisions

M+C organizations are required to adopt a compliance plan to prevent fraud and abuse. Although AACC agrees with HCFA’s objective, we do not support this mandatory requirement. The Office of the Inspector General (OIG) has developed "voluntary" compliance plans for clinical laboratories, hospitals and other health care providers. To date, many providers have implemented such plans to meet their specific needs. Rather than HCFA mandating M+C organizations adopt a hybrid of these plans, we would recommend that the Agency request the OIG to develop a similar voluntary compliance document for managed care plans.

422.520 Prompt payment by M+C organization

HCFA requires that M+C organizations pay 95 percent of "clean claims" submitted by non-contract providers, contract providers furnishing services not specified in their agreement, or claims submitted under a private fee-for-service plan within 30 days of submission (all other claims must be paid or denied within 60 days of submission). However, no specific timeframe is established for providers that have contracts with M+C organizations. AACC recommends that the 30/60-day payment period for non-contract providers be applied to contract providers, too.

Other recommendations

AACC also recommends that HCFA urge professional societies to develop practice guidelines, similar to the American Diabetes Association guidelines for diabetes, for other laboratory tests. These guidelines would serve as one method of monitoring the quality of care and appropriate utilization of services provided to M+C participants.

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, Director, Government Affairs at (202) 835-8721.


Stephen Kahn, PhD, DABCC


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