In re LCD Complaint: Noncovered Services: 0402T Corneal Collagen Cross-Linking, DAB CR5350 (2019)

DECISION

This case involves a Medicare beneficiary (herein “aggrieved party” or “AP”) who has challenged the portion of Local Coverage Determination (LCD) L33392, “Noncovered Services,” that pertains to a specific medical procedure, corneal collagen cross-linking (herein referred to as “CXL”).  A Medicare administrative contractor, National Government Services (NGS or “the contractor”), issued the LCD that, as relevant here, bars coverage for CXL in the geographic territory it oversees, which includes the AP’s state of residence, Massachusetts.  For the reasons stated herein, I find the LCD is reasonable.

I. Background

The AP challenges the inclusion of CXL in LCD L33392, which is listed as having a Category III CPT codeThe American Medical Association (AMA) maintains the current procedural terminology (CPT) coding system, and the AMA has stated the following regarding Category III CPT codes:
 

https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/cpt/cat-3-codes-first-10-yrs_1 (last visited June 11, 2019). of 0402T.

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The AP has a history of keratoconus.The National Institutes of Health (NIH) explains that keratoconus is “an eye condition that affects the shape of the cornea” in which the cornea “thins and bulges outward, resembling a cone shape.” NIH notes that keratoconus can lead to myopia, irregular astigmatism, and vision loss. https://ghr.nlm.nih.gov/condition/keratoconus#genes (last visited June 11, 2019).  AP Complaint; see AP Exhibit (Ex.) 4 at l.  In support of his complaint, the AP submitted a letter authored by Neil E. Ginsburg, M.D., in which Dr. Ginsburg explained that the AP underwent a corneal collagen cross-linking procedure in June 2018, which was performed by Robert Schulze, M.D.  AP Ex. 4.  Dr. Ginsburg stated that the CXL procedure is “considered the standard of care for keratoconus treatment and is covered by many private carriers.”  AP Ex. 4.  Dr. Schulze, an ophthalmologist affiliated with a different practice, authored a letter in which he succinctly explained that he performed CXL on the AP on June 21, 2018, and that the procedure was medically necessary.  AP Ex. 7.  The AP also submitted a copy of a letter from Joseph B. Gold, M.D., who is affiliated with the same practice as Dr. Ginsburg, in which Dr. Gold referred the AP to Dr. Schulze.  AP Ex. 6.  In support of his complaint, the AP submitted a journal article, “Updates on corneal collagen cross-linking:  Indications, techniques, and clinical outcomes,” that was published in 2017 by the Iranian Society of Ophthalmology in its Journal of Current Ophthalmology.I refer to this article as AP Ex. 3. The article can be found at Journal of Current Ophthalmology, Volume 29, Issue 4 (December 2017) 235-247.  The article stated that CXL “offers new hopes to treat corneal ectatic disorders,” and that “more studies are needed to evaluate the long-term results of this new modality and elucidate the place of CXL in surgical ophthalmology.”  AP Ex. 3 (page 243 of article).  The article concluded that CXL “is an emerging treatment method . . . that offers the possibility” to treat keratoconus.  AP Ex. 3 (page 235 of article).

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NGS contends that it was reasonable to include CXL, which has a Category III designation by the AMA, in the list of noncovered items or services in LCD L33392 because the AMA’s Category III designation of a “temporary code for emerging technology, services, and procedures” renders it experimental or investigational.  NGS Response at 2-4 (emphasis in original),NGS’s response is not paginated, and I refer to the pages numbers that appear in the PDF version of the electronically filed document. citing Current Procedural Terminology (CPT), Professional Edition (2016); Medicare Program Integrity Manual (MPIM), CMS Pub. 100-08, ch. 13 § 13.5.4.  NGS submitted as its sole exhibit a copy of the LCD, “Category III CPT® Codes- Related to Category III CPT® Codes (L33392).”NGS also provided notice that it would not file another exhibit containing excerpts from Current Procedural Terminology (CPT), Professional Edition (2016) because the material is subject to copyright. However, I note that a publicly available alternative source, the AMA’s website, contains nearly identical information regarding Category III codes that is referenced by NGS. See https://www.ama-assn.org/system/files/2019-03/cpt-category3-codes-long-descriptors (last visited June 11, 2019).  NGS Ex. 1.  The LCD indicates that CXL is “considered not medically necessary.”  NGS Ex. 1 at 10, 46-47.  NGS contends that inclusion in the LCD is reasonable because CXL “has been given a Category III designation by the AMA,” and that “[n]othing in the [AP’s] submission shows that the AMA’s designation was erroneous or ill-founded.”  NGS Response at 7.

In October 2018, NGS denied the AP Medicare reimbursement for his CXL procedure that was performed by Dr. Schulze in June 2018.  AP Ex. 1.  On February 1, 2019, the AP filed the Complaint pursuant to 42 C.F.R. § 426.400, in which he argued that the LCD “should no longer be applied to deny the medical necessity of [CXL] and that Medicare should cover this service and reimburse for it.”The LCD addresses numerous unrelated items and services that NGS has determined are not reasonable and necessary. This decision is limited to the specific item or service that is the subject of the AP’s complaint.  AP Complaint.  The AP’s complaint included eight exhibits, to include the aforementioned medical opinions from his ophthalmologists and the journal article published by the Iranian Ophthalmological Society.  AP Exhibit List; AP Exs. 1-8.

In an Order dated February 12, 2019, administrative law judge Leslie A. WeynThis case was reassigned to me on March 8, 2019.

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determined that the AP had filed an acceptable complaint pursuant to 42 C.F.R. § 426.410(b).  Thereafter, in compliance with her February 12, 2019 Order and 42 C.F.R. §§ 426.418 and 426.419, NGS submitted the LCD Record and the AP submitted an additional exhibit (AP Ex. 9), along with his Statement as authorized by 42 C.F.R. § 426.425(a).  See AP Ex. 9.  NGS submitted its response as authorized by 42 C.F.R. § 425.425(b).

The record of this case is closed.  There are no pending evidentiary objections, and neither party has requested a live hearing for the purpose of obtaining testimony or cross-examination.  The record consists of the AP’s Complaint, the AP’s Statement, the NGS Response, AP Exs. 1 through 9, and NGS Ex. 1.

II.  Discussion

A.  Applicable Law

Section 1831 of the Social Security Act (“the Act”), codified at 42 U.S.C. § 1395j, establishes the supplementary medical insurance benefits program for the aged and the disabled known as Medicare Part B.  Section 1862 of the Act (42 U.S.C. § 1395y) provides that no payment may be made for items or services “which . . . are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. . . .”  The Secretary of the Department of Health and Human Services has promulgated implementing regulations, to include rulemaking that any services not reasonable and necessary for one of the purposes listed in the regulations are excluded from coverage under Medicare.  42 C.F.R. § 411.15(k).  The Centers for Medicare & Medicaid Services (CMS) has established policy, through the Medicare Benefit Policy Manual (CMS Pub. 100-02, ch. 16, §§ 10 and 20), that provides that no payment may be made for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.  An LCD, as defined by the Act, is “a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered” within the area covered by the contractor.  Act, § 1869(f)(2)(B) (42 U.S.C. § 1395ff(f)(2)(B)).  The regulations implementing sections 1869(f)(1) and (f)(2) of the Act are found at 42 C.F.R. Part 426.  The procedures for review of an LCD are contained in 42 C.F.R. Part 426, Subpart D (42 C.F.R. § 426.400 et seq.).

In deciding the AP’s challenge to the LCD, I must decide whether the LCD satisfies the reasonableness standard of 42 C.F.R. § 426.110.  42 C.F.R. § 426.425(c).  The reasonableness standard provides the following, in pertinent part:

In determining whether LCDs . . . are valid, the adjudicator must uphold a

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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 . . . are reasonable based on the LCD . . . record and the relevant record developed before the ALJ . . . .

42 C.F.R. § 426.110.  Additional discussion of the reasonableness standard is contained in the final rule, which includes the following discussion:

We are using the statutory language from sections 1869(f)(1)(A)(iii) and (f)(2)(A)(i) of the Act, which instructs adjudicators to defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.

The logical corollary is that the ALJs and the [Departmental Appeals Board] must accord deference if the contractor’s or CMS’s findings of fact, interpretations of law, and application of fact to law are reasonable.  The concept of deference is one that is generally applied by courts to administrative decisionmaking, in recognition of the expertise of a program agency.  Thus, we view the statute as setting out a reasonableness standard that recognizes the expertise of the contractors and CMS in the Medicare program--specifically, in the area of coverage requiring the exercise of clinical or scientific judgment.

So long as the outcome is one that could be reached by a rational person, based on the evidence in the record as a whole (including logical inferences drawn from that evidence), the determination must be upheld.  This is not simply based on the quantity of the evidence submitted, but also includes an evaluation of the persuasiveness of the material.  If the contractor or CMS has a logical reason as to why some evidence is given more weight than other evidence, the ALJs and the Board may not overturn the determination simply because they would have accorded more weight to the evidence in support of coverage.  In some situations, different judgments by different contractors may be supportable, especially if explained by differences such as the ready availability of qualified medical professionals in one contractor’s area, but not in another.  Moreover, an ALJ or the Board may not determine that an LCD is unreasonable solely on the basis that another Medicare contractor has issued an LCD that permits coverage of the service at issue, under the clinical circumstances presented by the complaint.

For legal interpretations, the reasonableness standard would not be met if

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an interpretation is in direct conflict with the plain language of the statute or regulation being interpreted.  Moreover, an interpretation in an LCD would not meet the reasonableness standard if it directly conflicts with an NCD or with a CMS Ruling.  So long as an interpretation is one of the readings permitted by the plain language of the law and can be reconciled with relevant policy, however, it must be upheld, even if the ALJ or the Board might have reached a different result if interpreting the statute or regulation in the first instance.

68 Fed. Reg. 63,692, 63,703-04 (Nov. 7, 2003).

In reviewing the AP’s complaint, I must determine whether the LCD record is complete and adequate to support the validity of the LCD provisions under the “reasonableness standard.”  Consistent with the discussion above, I will find an LCD valid “‘if the findings of fact, interpretations of law, and applications of fact to law by the contractor . . . are reasonable’ based on the record developed” pursuant to 42 C.F.R. part 426.  LCD Complaint: Glucose Monitors, (L11530/L33822 and Local Coverage Articles A33614/A52464), DAB No. 2782 at 4 (2017), citing 42 C.F.R. §§ 426.110, 426.300(a), 426.425(c)(1), and 426.476(b)(1).  In determining whether the LCD is reasonable, I do not substitute my own policy judgments or determinations regarding whether a procedure should be covered, but rather, I determine whether the LCD is reasonable.  Further, I do not determine whether a particular Medicare beneficiary, namely the AP, would individually benefit from the procedure at issue.  Rather, I determine whether the LCD is reasonable as applied to all beneficiaries affected by the LCD.

For the reasons stated herein, I find that the LCD record is complete and the LCD satisfies the reasonableness standard.  42 C.F.R. § 426.450(a)(1) and (4).

B.  The LCD

On October 4, 2018, NGS informed the AP that it had denied reimbursement for “[c]ollagen cross linking treatment of disease of cornea (0402T-LT),” based in part on the LCD.  AP Ex. 1.  The AP submitted an excerpt from LCD L33392 with his complaint, and NGS has submitted the LCD as NGS Ex. 1.  The LCD states:

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Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

The American Medical Association (AMA) develops Current Procedural Terminology (CPT) Category III codes to allow for data collection concerning the use of “emerging technology, services, and procedures.”  The creation of a CPT Category III code by the AMA “neither implies nor endorses clinical efficacy, safety or the applicability to clinical practice.”

Because of the specific purpose these Category III codes serve, National Government Services will consider the item, service, or procedure represented by these codes to be not medically necessary, unless the item, service, or procedures is listed below under the “Indications and Limitations for Category III CPT Codes Considered Reasonable and Necessary” section of the LCD.  If a provider believes that any Category III code, included in the CPT Code Section, Group 1, qualifies for coverage (is proven to be safe and effective as well as reasonable and necessary), the provider may request coverage and inclusion of the Category III code in this LCD or in its own LCD through the LCD Reconsideration Process.  Peer reviewed scientific evidence is required for consideration.

AP Ex. 2.  The LCD indicates that “[t]he Category III CPT codes listed below are considered not medically necessary,” and the listed codes include the following, as relevant here:

0402T COLLAGEN CROSS-LINKING OF CORNEA (INCLUDING REMOVAL OF THE CORNEAL EPITHELIUM AND INTRAOPERATIVE PACHYMETRY WHEN PERFORMED)

NGS Ex. 1 at 10, 46-47 (capitalization in original).

C.  Issue

The issue in this case is whether the challenged portion of LCD L33392 pertaining to CXL satisfies the reasonableness standard defined by 42 C.F.R. § 426.110.

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D.  Findings of fact and conclusions of lawFindings of fact and conclusions of law are in italics and bold font.

1. The LCD record is complete and adequate to support the validity of the LCD provision at issue.
2. I find the challenged portion of the LCD is valid under the reasonableness standard.

Pursuant to Section 1862(a)(1)(A) of the Act, payment may not be made under Medicare Part B for a service that is not reasonable and necessary.  Pursuant to 42 C.F.R. § 400.202, a Medicare contractor may issue an LCD determining whether it will cover an item or service under section 1862(a)(1)(A) of the Act.  The MPIM instructs that a service is reasonable if the contractor determines that the service meets the following criteria:

• Safe and effective;
• Not experimental or investigational (exception:  routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000[,] which meet the requirements of the Clinical Trials [national coverage determination] are considered reasonable and necessary); and
• Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • One that meets, but does not exceed, the patient’s medical need; and
  • At least as beneficial as an existing and available medically appropriate alternative.

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MPIM, § 13.5.1 (Rev. 473, eff. January 15, 2013).I cite to the 2013 version of the MPIM that was in effect when NGS denied the AP’s claim. Chapter 13 of the MPIM was significantly revised effective January 8, 2019. The aforementioned discussion is now found in section 13.5.4 of the MPIM that is currently in effect.  The MPIM also instructs contractors of the basis for an LCD, stating:

Contractor LCDs shall be based on the strongest evidence available.  The extent and quality of supporting evidence is key to defending challenges to LCDs.  The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question.  In order of preference, LCDs should be based on:

• Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and
• General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
  • Scientific data or research studies published in peer-reviewed medical journals;
  • Consensus of expert medical opinion (i.e., recognized authorities in the field); or
  • Medical opinion derived from consultations with medical associations or other health care experts.

Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community.  Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community.  The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached.

Id.

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The AP argues that CXL is “safe and highly effective” and that many private insurance companies are covering this procedure.  AP Complaint at 3.  The AP also argues that CXL “is generally accepted by the medical community” and that his ophthalmologist, Neil Ginsburg, M.D., opined that it is the standard of care.  AP Complaint, citing AP Ex. 4.  The AP further contends that Joseph Gold, M.D., referred him to Dr. Schulze for the CXL procedures.  AP Ex. 6; see AP Ex 7.  The AP argues that the journal article he submitted as AP Ex. 3 supports that Medicare should cover CXL, and he claims that the Food & Drug Administration (FDA) has approved the procedure.  NGS argues that “there is currently not enough medical evidence to warrant Medicare coverage for CXL” and that “[t]he instant challenge fails to show this determination was unreasonable.”  NGS Response at 2.  NGS also contends that “there is simply not sufficient evidence to show that the AMA’s Category III designation was unwarranted or that NGS’s inclusion of CXL in its Category III LCD was unreasonable.”  NGS Response at 6.  NGS argues that “[n]othing in the Aggrieved Party’s submission shows that the AMA’s designation was erroneous or ill-founded,” and the “one scientific article submitted by the Aggrieved Party concedes that CXL is still evolving and that more studies are needed to establish its efficacy.”  NGS Response at 7.  NGS also argues that the AP has not demonstrated that the FDA has approved the procedure, and further contends that FDA approval is nonetheless not dispositive of whether an item or service is reasonable and necessary.  NGS Response at 5-6.

The AP has the burden of proof and persuasion in this matter; I consider the AP’s challenge based on a reasonableness standard.  42 C.F.R. §§ 426.300, 426.330.  The AP has not met his burden to show that the denial of coverage for CXL by the LCD is not reasonable.

By virtue of its designation of being coded as a Category III item or service, CXL is an emerging procedure.  See AP Ex. 3 (page 235 of article) (journal article’s conclusion that CXL is “an emerging treatment method in ophthalmology that offers the possibility to effectively treat progressive [keratoconus]”).  While CXL may be promising and may ultimately become a covered service at some point in the future, NGS’s LCD barring coverage is reasonable based on CXL’s current classification as an emerging procedure.  The AP has not shown that, as an emerging item or service, CXL is safe and effective, nor has he demonstrated that CXL is not experimental or investigational at this juncture.  See MPIM, § 13.5.1 (Rev. 47, eff. January 15, 2013).  While the available evidence indicates that the AP’s individual CXL procedure was successful, the AP has not identified evidence, to include peer-reviewed journal articles, demonstrating that CXL would be safe and effective for all beneficiaries throughout NGS’s jurisdiction.  Likewise, even though the AP has submitted letters from three ophthalmologists who are supportive of CXL, I note that none of those ophthalmologists explained why the procedure should be considered reasonable and necessary consistent with Section

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1862(a)(1)(A) of the Act.Although Dr. Ginsburg stated that the CXL “is the standard of care for keratoconus treatment,” he provides essentially no support for that statement. AP Ex. 4. Similarly, although Dr. Gold referred the AP to Dr. Schulze for the CXL procedure, Dr. Gold provides no opinion regarding the efficacy of CXL. AP Ex. 6. And Dr. Schulze, who performed the surgery in New York, merely states that the procedure was medically necessary without any further elaboration. AP Ex. 7.  The evidence submitted by the AP does not demonstrate acceptance of CXL by the medical community, as would ordinarily be evidenced by peer-reviewed literature or medical expert opinions.  MPIM, § 13.7.1 (Rev. 473, eff. January 15, 2013).  Further, even though the AP submitted a journal article published by the Iranian Society of Ophthalmology, I note that the article’s authors concluded that CXL is an emerging treatment that offers the “possibility” to effectively treat keratoconus but nonetheless recognized that additional studies are necessary to assess long-term results.  AP Ex. 3 (pages 235, 243 of article).

The AP also argues, without supporting evidence, that CXL is approved by FDA.NGS argues that “[a] search of the FDA’s Web site revealed approval of two chemical solutions, manufactured by Avedro, Inc., that can be used in CXL” and that its research “did not yield any over-arching approval of the CXL procedures by the FDA.” NGS Response at 6. The physician who performed the procedure, Dr. Schulze, did not state whether he performed an FDA-approved procedure. AP Ex. 4.  However, the Departmental Appeals Board (DAB) has noted that FDA approval is not dispositive of whether an item or service should be covered by Medicare.  The DAB has stated that CMS, which oversees Medicare administrative contractors such as NGS, is not obligated to determine an item or service is reasonable just because it is FDA-approved, stating:

For some items, such as drugs and biologicals, CMS accepts the FDA’s safety and effectiveness findings as sufficient evidence that the item is reasonable and necessary (and thus entitled to Medicare coverage) for the FDA-approved indication.  See 67 Fed. Reg. at 66,756; Medicare Benefit Policy Manual (CMS Pub. 100-02), ch. 15 § 50.4.1 (available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673.html).  But CMS is under no legal obligation to do so; it may, in its discretion, “choose to perform a reasonable and necessary determination” despite FDA approval.  67 Fed. Reg. at 66,756 (specifying circumstances in which CMS may elect not to accept the FDA’s findings); Almy v. Sebelius, 679 F.3d at 308 (noting, in a case involving the FDA

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510(k) process, that “[w]hile FDA approval may . . . inform [CMS]’s decision as to whether a device is ‘reasonable and necessary,’ it cannot tie [CMS]’s hands”).

NCD 160.18 Vagus Nerve Stimulation, DAB No. 2613 at 37 n.27 (2014).  Even if CXL is FDA-approved (which the AP has not proven), the AP has not shown the procedure is reasonable and necessary by virtue of the FDA’s approval.

Based on the aforementioned discussion, I find that the portion of the LCD at issue involving coverage of CXL (CPT code 0402T) is valid and reasonable under the reasonableness standard.

3.  The AP’s challenge to LCD L33392 is denied.

Since I find that the LCD record is complete and adequate to support the validity of the challenged LCD under the reasonableness standard, “issuance of a decision finding the record complete and adequate to support the validity of the LCD ends the review process.”  42 C.F.R. § 426.425(c)(2).  I therefore deny the challenge to LCD L33392.