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CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  

In re CMS LCD COMPLAINT:

    Local Coverage Determination:
    Blood Glucose Testing, LCD L1316
    (Lillian Spooner and Delores Shaw)

DATE: December 22, 2006
     

Docket No.C-06-568
Decision No. CR1548

Docket No. C-06-569
Decison No. CR1549

 

 

DECISION
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DECISIONS

I issue these two decisions deciding hearing requests brought by two aggrieved Medicare beneficiaries challenging Local Coverage Determination L1316 (LCD), issued by Blue Cross/Blue Shield of Tennessee (Riverbend Government Benefits Administrator), governing payment by the Medicare program for blood glucose testing. (1) I find the LCD determination to be reasonable. As part of my decision, I find to be without merit the aggrieved beneficiaries' arguments that the LCD is superseded by, or inconsistent with, a National Coverage Determination (NCD) or that it is inconsistent with other law, policy, or regulations.

I. Background and undisputed facts

I hear and decide these cases pursuant to regulations governing challenges to LCDs published at 42 C.F.R. Part 426, Subparts C and D. For purposes of these decisions I accept as true the following facts alleged by the two aggrieved beneficiaries. Each of them is a resident of a long term care facility (apparently, a skilled nursing facility) that participates in the Medicare program pursuant to Part A of that program, the part that provides reimbursement to institutional providers. (2) Each of the aggrieved beneficiaries is diabetic. In each case the beneficiary received routine blood glucose monitoring by finger stick testing, performed by the nursing staff of her long term care facility. The facility submitted reimbursement claims for this blood glucose testing as Part B Medicare items or services. The rationale for each of the reimbursement claims was that it was for a Part B covered laboratory procedure. Each claim was denied based on the terms of the LCD.

In each case, the aggrieved beneficiary submitted a hearing request with various attachments. I directed the intermediary to provide me with a copy of its LCD record. In each case the intermediary submitted its LCD record under cover of a letter dated August 29, 2006. I provided the aggrieved beneficiaries with the opportunity to comment on the LCD record and to provide supplemental evidence. The parties' representative made submissions on October 12, 2006 and October 16, 2006. I then provided the intermediary with an opportunity to file a response to the aggrieved beneficiaries' submissions. The intermediary did so with responses that it filed on November 8, 2006.

The beneficiaries' representative has not requested that there be an in-person hearing. He has not proffered testimony on behalf of the aggrieved beneficiaries. Therefore, I find the records of these cases to be closed. I am designating the hearing request and its attachments in C-06-568 as 06-568 Exhibit (Ex.) 1, the LCD record as 06-568 Ex. 2, the October 12 submission as 06-568 Ex. 3, and the intermediary's November 8 response as 06-568 Ex. 4. I am designating the hearing request and its attachments in C-06-569 as 06-569 Ex. 1, the LCD record as 06-569 Ex. 2, the October 16 submission as 06-569 Ex. 3, and the intermediary's November 8 response as 06-569 Ex. 4. I receive these exhibits into the records of the two cases.

II. The LCD

In relevant part the LCD provides as follows:

The routine or standing order use of a home glucose monitoring device . . . will only be considered medically necessary as a laboratory procedure when the physician is PROMPTLY informed of the result PRIOR to the next testing episode. Blood glucose monitoring . . . without this reporting is part of the patients' self-care. If the patient is in a skilled nursing facility, routine glucose monitoring (including any tests, which are not promptly reported) is a part of routine personal care and is not a separately reportable or billable procedure . . . .

C-06-568 Ex. 1, Attachment D, at 4; C-06-569 Ex. 1, Attachment D, at 4.

The LCD precludes reimbursement under Medicare Part B for blood glucose monitoring that is performed on a routine basis, either by a Medicare beneficiary at home, or by a skilled nursing facility's staff, where the result of each test is not promptly reported to the beneficiary's treating physician. Thus, blood glucose monitoring that is done several times daily to check blood sugar levels and to adjust the correct dosage of daily insulin injections, but which is not promptly reported to a beneficiary's treating physician, is not covered as a Part B reimbursable item or service. In the nursing facility setting, reimbursement for such services is considered to be an element of the global compensation that Medicare reimburses the facility under Part A of the Medicare program beneficiary's institutional care.

The LCD does not categorically deny reimbursement under Part B for all blood glucose testing. A blood glucose test is reimbursable under Part B as a separate item or service if a physician orders a specific test for a diagnostic purpose and the result of that test is reported back to the physician promptly and prior to the next test being performed. The obvious distinction created by the LCD is to allow per-test compensation under Part B for tests that are ordered specifically for diagnostic purposes, as opposed to those that consist of routine self-monitoring by the beneficiary or routine monitoring that is performed for the beneficiary by a nursing facility staff. These latter tests are reimbursed as part of the Part A fee.

III. Issues, findings of fact and conclusions of law

A. Issue

The issue in this case is whether the LCD unreasonably prohibits Part B Medicare reimbursement for routine glucose monitoring performed at a long term care facility under circumstances where the result of the testing is not promptly reported to a beneficiary's physician prior to the next testing episode.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in these cases. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. There is no dispute that the tests that are at issue in these cases were not "promptly" reported to the aggrieved beneficiaries' treating physicians.

What the aggrieved beneficiaries seek here is a decision that the distinction drawn by the LCD between tests that are promptly reported and those that are not is unreasonable. The beneficiaries would have me hold that it is unreasonable to preclude payment under Part B of Medicare for each test result, whether or not it is promptly reported, and whether or not it is for routine monitoring as opposed to being ordered by a physician for a specific diagnostic purpose. The undisputed factual premise that underlies the beneficiaries' argument is that the blood glucose monitoring that they received consisted of routine monitoring that was not promptly reported to the residents' physicians. Otherwise, there would be no factual basis for the beneficiaries' challenge of the LCD.

2. The LCD does not conflict with, nor is it superseded by, a National Coverage Determination (NCD).

The aggrieved beneficiaries contend that an NCD entitled, "Medicare National Coverage Determination 190.20 - Blood Glucose Testing," directs that all blood glucose testing, whether performed for a specific diagnostic purpose and immediately reported, or performed as routine monitoring and not immediately reported, be reimbursed under Part B of Medicare. (3) They assert that, as a matter of law, an NCD will supersede an LCD that is in conflict with the NCD. They contend, therefore, that the LCD in this case is invalid because it is in conflict with the NCD and is superseded by it.

I agree with the aggrieved beneficiaries that an LCD may be superseded by an NCD. An NCD establishes national reimbursement policy for the Medicare program and such policy will supersede or overrule any conflicting regional or local policy. However, there is no conflict between the NCD cited by the aggrieved beneficiaries and the LCD that is at issue here. The aggrieved beneficiaries' arguments notwithstanding, the NCD does not direct payment under Medicare Part B for routine blood glucose monitoring. In a manner that is completely consistent with the LCD, the NCD establishes ground rules for reimbursing blood glucose screening tests under Part B. It allows for reimbursement for such tests under Medicare Part B in some very limited and clearly defined circumstances. It says nothing to suggest that routine screening tests will be reimbursed as Part B items or services.

The NCD does not express a general policy that Medicare will reimburse under Part B for all blood glucose testing. Rather, it states that some forms of blood glucose testing "may be covered" for screening purposes subject to specified frequencies. 06-568 Ex. 4; 06-569 Ex. 4. This is not a mandate to pay under Part B for all blood glucose testing including self-testing or testing done on a routine basis in a nursing facility. To the contrary, it is an indication that blood glucose testing may be reimbursable under Part B in limited circumstances. The NCD goes on to state that these limited circumstances may include blood glucose testing in diabetic patients who are unable or unwilling to do home monitoring, but generally only up to four times annually. The NCD allows for Part B reimbursement for blood glucose testing in such patients more than four times annually:

Depending upon the age of the patient, type of diabetes, degree of control, complications of diabetes, and other co-morbid conditions . . . .

In sum, the NCD states no policy that routine blood glucose monitoring - as distinguished from specific tests performed in enumerated circumstances - is a Part B reimbursable item or service. Rather, it implies strongly by specifically stating that monitoring generally will be reimbursed up to four times annually, and by enumerating a narrow exception to this rule, that additional monitoring normally is not reimbursable under Part B. That is completely consistent with the LCD's distinction between a non-Part B reimbursable routine blood glucose monitoring test and a reimbursable test that is ordered for a diagnostic purpose and which is promptly reported to a treating physician.

The NCD in these cases is authorized by a regulation governing payment under Part B of Medicare for diabetes screening tests. 42 C.F.R. 410.18. The regulation, which incorporates the NCD by reference, is consistent with the LCD. 42 C.F.R. 410.18(c)(3). Nothing in the regulation states or suggests that routine blood glucose monitoring is reimbursable under Part B. Indeed, the specific circumstances in which tests are covered, enumerated at 42 C.F.R. 410.18(c), do not mention routine blood glucose monitoring.

3. The LCD does not conflict with law regulating certification of clinical laboratories.

The aggrieved beneficiaries assert that the facilities at which they reside have received waivers under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) and implementing regulations to perform certain types of tests which, according to them, include routine blood glucose testing. See 42 C.F.R. Part 493. These facilities, according to the aggrieved parties, are "clinical laboratories" within the meaning of CLIA and its implementing regulations. The aggrieved beneficiaries contend that the routine blood glucose tests that are provided to them are CLIA-certified laboratory tests by virtue of the CLIA waivers received by the facilities in which they reside. They argue that the Medicare program pays for all CLIA-certified laboratory tests and, as a result, the tests that are at issue here must be compensated by Medicare. Consequently, according to the aggrieved beneficiaries, the LCD is invalid as a matter of law to the extent that it conflicts with the asserted requirement that Medicare pay for all CLIA-approved laboratory tests.

I find this argument to be without merit. CLIA and its implementing regulations regulate the types of laboratory facilities that may be certified to conduct clinical testing and the types of tests that these facilities may perform. They do not govern what types of tests will be compensated by the Medicare program, or how the program will compensate for these tests. There is nothing in CLIA or in implementing regulations that directs the Medicare program to reimburse clinical laboratories for all CLIA-certified tests. Nor is there anything in CLIA that defines the type of reimbursement (Part A versus Part B) that Medicare will provide for those services that are covered under Medicare. Thus, the fact that a skilled nursing facility may be approved pursuant to CLIA to provide certain types of clinical laboratory tests does not mean that, as a matter of law, every test that is performed on its premises is compensable under Medicare, or under Medicare Part B as opposed to Medicare Part A.

What may be reimbursable by Medicare, and how it may be reimbursed, is not regulated by CLIA but elsewhere in federal law and regulations governing the Medicare program. It is consistent with CLIA that a facility may be certified to perform a particular type of test that is not reimbursable under Part B of Medicare. Moreover, the Medicare program does not reimburse for every clinical laboratory test but only for those which it has approved as covered items or services. As I discuss above, at Finding 2, reimbursement for blood glucose testing is regulated explicitly by federal regulations, an NCD, and the LCD that is at issue here. These authorities make it plain that blood glucose monitoring will be reimbursed by Part B of Medicare in certain circumstances but not automatically in all circumstances.

In addition to the specific law and regulations governing blood glucose testing, there is a regulation that states the general rule governing payment under Part B for diagnostic laboratory tests. That is 42 C.F.R. 410.32 and it states in relevant part that Medicare Part B pays for covered diagnostic laboratory tests. 42 C.F.R. 410.32(d). Tests performed by a clinical laboratory are reimbursable if they are covered tests. 42 C.F.R. 410.32(d)(1)(v). The regulation thus distinguishes between a laboratory test and a covered laboratory test. Only a covered test is reimbursable under Medicare Part B and, as I have discussed above, the tests that are at issue here are not covered by Part B.

4. The LCD is reasonable.

The test that I am required to apply in deciding whether an LCD is valid - as opposed to deciding whether the LCD conflicts with or is superseded by an NCD or conflicts with other law - is defined in regulations as the "reasonableness standard." Specifically:

In determining whether . . . [an LCD] is valid the . . . [administrative law judge] must uphold a challenged policy (or a provision or provisions of a challenged policy) if the findings of fact, interpretations of law, and applications of fact to law by the contractor or CMS [The Centers for Medicare & Medicaid Services] are reasonable based on the LCD . . . record and the relevant record developed before the . . . [administrative law judge].

42 C.F.R. 426.110.

I have considered the LCD based on the records in each of these cases and I find it to be reasonable. The LCD is consistent with two long-standing CMS policies. First, it conforms to CMS's policy that Medicare will not pay under Part B for routine self-administered glucose screening tests. Second, it conforms to CMS's policy - incorporated in governing regulations - that skilled nursing facility services are not generally compensable under Part B of the Medicare program.

The purpose of the LCD is to apply to the setting of a skilled nursing facility CMS's long-standing and general rule that the Medicare program will not reimburse under Part B for blood glucose self-testing performed by diabetic beneficiaries as part of their routine care. The LCD analogizes the routine testing that may be performed in a skilled nursing facility, with the assistance of or by facility staff, with that which a beneficiary would perform by himself or herself if at home. This policy expressed in the LCD is consistent with CMS's general policy not to pay for self-testing:

[U]nderscoring the self-care nature of ongoing monitoring, it is important to note that, if the beneficiary were in a private residence, she or a family member would be expected to self-manage this level of care, as it does not meet the definition of skilled care for Home Health . . . On any given day hundreds of thousands of diabetics nationwide monitor their blood glucoses using home monitors without the benefit of diagnostic labs or skilled staffs of any type.

* * * *

The current CMS manual makes it clear that this distinction is still made between routine home monitoring as self care and physician directed diagnostic testing. CMS Manual 100-4 Ch7 Part B Skilled Nursing facilities; Section 90.1 - Glucose Monitoring states: "Routine glucose monitoring of diabetics is never covered in a . . . [skilled nursing facility], whether the beneficiary is in a covered Part A stay or not. Glucose monitoring may only be covered when it meets all the conditions of a covered laboratory service, including use by the physician in modifying the patient's treatment."

06-568 Ex. 4, at 2-3; 06-569 Ex. 4, at 2-3.

Furthermore, the LCD comports with regulations that require skilled nursing facility services to be paid for under Part A of the Medicare program. 42 C.F.R. 411.15(p). Under Part A of Medicare the portion of that care that might be devoted to assisting beneficiaries with routine blood glucose screening is compensated as part of the overall compensation that Medicare gives to a facility for each eligible beneficiary's care. Thus, the LCD merely expresses explicitly for blood glucose testing, and entirely consistent with the governing regulation, the general policy of CMS not to pay under part B of Medicare for itemized services provided by a skilled nursing facility.

The aggrieved beneficiaries have offered no evidence to show that routine blood glucose screening is a unique item or service that merits reimbursement separate from the global care fee paid under Part A of the Medicare program. They have not argued that the tests for which they seek reimbursement are anything other than routine screening tests nor have they established anything about these tests - the nature of the tests, the level of skill that is required to administer or interpret them, or the uses to which the results of these tests are put - that would distinguish routine blood glucose testing from the routine services that are performed at a skilled nursing facility and which are reimbursed under Part A. As the intermediary notes, the identical tests to those for which the aggrieved parties demand coverage under the LCD are performed at home, hundreds of thousands of times daily, by beneficiaries, and the costs of these tests are not reimbursed under Part B of Medicare. The aggrieved parties have offered nothing to prove that these tests involve any different methodology or skills when performed by nursing facility staff as than when performed by the beneficiaries themselves.

In case C-06-568, the aggrieved beneficiary attached to her hearing request a decision by an administrative law judge finding that blood glucose monitoring tests furnished to a Medicare beneficiary in a skilled nursing facility were reasonable and necessary as is defined at section 1862(a)(1) of the Social Security Act (Act) and, therefore, reimbursable under Part B of the Medicare program. DuPage Convalescent Home, Appellant, Eunice Hemby, Beneficiary, OHA Docket No. 999-29-0366 (2004). The aggrieved parties evidently urge that I consider this decision to be precedent for concluding that the LCD in these cases is unreasonable. I do not find the decision to be precedential. The decision does not address - or even mention - the LCD that is at issue here. (4) It is not a case in which the reasonableness of the LCD is addressed. Rather, it addresses only the issue of whether denials of payments of individual claims for reimbursement pursuant to Part B of Medicare were proper. That latter issue is not before me. My decisions in these cases find only that the LCD at issue here is reasonable.

Furthermore, Section 1862(a) of the Act does not direct reimbursement under Part B of Medicare for every item or service that is "reasonable and necessary." Section 1862(a) is a proscription against reimbursement under Parts A and B of Medicare for certain defined items or services. It does not state - either explicitly or impliedly - that those items or services that are not listed under the section must be reimbursed by Medicare or that they must be reimbursed under a specific Part of Medicare.

 

JUDGE
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Steven T. Kessel

Administrative Law Judge

FOOTNOTES
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1. The governing LCD, law, and relevant facts in the two cases are identical. The aggrieved party in each case is represented by the same individual. I am issuing consolidated decisions for efficiency purposes. However, each of the two aggrieved parties has standing to appeal my decision with respect to her.

2. As a general rule, institutional providers such as nursing facilities receive reimbursement for the care that they give to eligible beneficiaries under Part A of the Medicare program. Part A reimbursement consists essentially of a global fee for the services that a facility gives to each eligible beneficiary. Under Part A, specific items or services are not reimbursed separately. By contrast, under Part B, which is used generally to reimburse non-institutional providers such as physicians, reimbursement is made for specific items or services.

3. The aggrieved beneficiaries submitted extracts from the NCD as part of their hearing requests. The intermediary provided me with the complete document as an attachment to its submission in each of these cases. 06-568 Ex. 4; 06-569 Ex. 4. I rely on the NCD supplied by the intermediary as the complete and accurate text of the NCD.

4. The administrative law judge in this case cites to a Local Medical Review Policy (LMRP) which he finds not to be binding on him. The text of the LMRP is not made part of the decision. I make no finding here as to whether an LMRP is binding on an administrative law judge. However, it is plain from the decision that the administrative law judge made no findings about the reasonableness of the LCD that is at issue here.

CASE | DECISION | JUDGE | FOOTNOTES