Skilled nursing facility providers decry new CMS regulations requiring the certification of each blood glucose test prior to billing.

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esponding to industry inquiries on the Centers for Medicare & Medicaid Services (CMS) policy on blood glucose monitoring in the skilled nursing facility (SNF) setting, the agency issued a proposed rule in August 2006. The proposed rule clarified its “long-standing policy” and addressed physician certification requirements for billing of blood glucose tests under Medicare Part B as well as the use of “standing orders” to meet the medical necessity requirements.
       Under the new regulation, CMS would require for each and every blood glucose test performed and billed under Medicare Part B to be certified by the physician to meet the certification requirement under §424.24(f). In addition, the rule states that a standing order is not sufficient to order a series of blood glucose tests, essentially requiring a separate order for each test that is billed to Medicare Part B. The agency also points out that this amendment would only affect those services that are furnished by a provider of services for which the provider seeks payment under Medicare Part B. To the extent payment is available under Medicare Part A, the certification requirement would not apply.
       Despite strong opposition from SNF providers, national organizations, such as the American Diabetes Association (ADA), the American Health Care Association (AHCA), and the Alliance for Quality Nursing Home Care (The Alliance), and senators Susan M. Collins and Blanche L. Lincoln, CMS published a Final Rule on this matter on December 1, 2006, proceeding with its proposed certification requirement. The agency contends that the requirements do not impose any new obligations but merely codify as a condition of payment what has long been required under §410.32(a) and CMS program instructions.

Background

       The issue of billing for blood glucose monitoring has been a point of controversy and confusion in the long-term care industry for many years. CMS and local contractors have developed and implemented many different coverage decisions on this topic, adding to the confusion over whether a SNF can appropriately bill for blood glucose testing. The enforcement of the local coverage determinations (LCDs), formally local medical review policies (LMRP), has resulted in an increasing number of denials, forcing many long-term care providers to cease submitting Medicare Part B claims for blood glucose tests performed. Other providers continued to bill, get denied, and pursue Medicare appeals—often with successful outcomes at the Administrative Law Judge (ALJ) level.
       Where exactly does the confusion lie? It would appear that the main point of contention is the determination of what deems the blood glucose test reasonable and necessary and thus eligible for payment under Medicare Part B. The Code of Federal Regulations at §410.32(a) specifically states the following in relationship to medical necessity: “All diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary—that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.”
       CMS then released Transmittal AB-00-08 in December 1, 2000, due to a significant increase in the number of claims submitted to intermediaries for glucose monitoring with a home-use device. In the transmittal, CMS reiterated the aforementioned physician order requirements but added the following in relationship to the physician utilizing the results of in the management of the beneficiary’s specific medical problem: “Implicitly, the laboratory result must be reported to the physician promptly in order for the physician to use the result and instruct continuation or modification of patient care; this includes the physician’s order for another laboratory service.” This particular statement was incorporated into many LMRPs developed by fiscal intermediaries (FIs) and resulted in an increase in denial of claims due to failure of SNF providers to notify the physicians of the results after each blood glucose test.
       Furthermore, Transmittal AB-00-88 informed providers that experts involved in the clinical, laboratory-negotiated rule-making process determined that blood glucose laboratory testing warrants a national coverage policy. A final national coverage decision (NCD) was implemented in November 2002. This NCD made no reference to reporting of results to a physician under any particular timeframe. In fact, the section on reasons for denials makes no mention of denying claims based on timely physician notification.
       In one ALJ decision, the ALJ mentioned this omission in the NCD and stated, “The [NCD] does not contain the specific notification requirements imposed by the carrier in its LMRP and contained in CMS policy prior to the publication of the NCD. The fact that CMS’s prior policy is not contained in the NCD is significant. Clearly the framers of the NCD could have incorporated the existing Medicare policy into their NCD had they chosen to do so. The absence, in the NCD, of the restrictive language contained in CMS’s prior policy, together with the NCD’s language encouraging frequent testing and recognizing it as the standard of care, strongly suggests that the framers of the NCD intended to expand Medicare coverage of glucose monitoring using home-use devices, even for residents of nursing homes not eligible for coverage under Part A of Medicare.”
       Under current CMS policy and regulation, local contractors may not develop or maintain LMRPs that conflict with NCD. If an existing LMRP conflicts with an NCD, it must be revised to conform to the NCD. The ALJ determined that the local contractors’ LMRP was superseded by the development of the NCD; the LMRP was found to be in direct conflict since the NCD did not (and still does not) contain the notification requirements imposed in the contractors’ LMRP.
       Another reason for denial was the fact the FIs deemed the frequent blood glucose testing “routine” and, therefore, not reimbursable under the Medicare program. In contrast, Transmittal AA-00-08 states “denial of payment for a Part B-covered laboratory service cannot be made on the basis that the service is routine care.” Under Medicare, routine care determinations are applicable only for Part A nursing home services. For this reason, the ALJ would not allow the denial to be upheld based on the FIs’ interpretation of the test being performed as routine.

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