Commercial Insurance Payer Coverage Criteria for Meniscal Allograft Transplantation Poorly Reflect Modern Indications for the Procedure

Abstract

Objective

To investigate whether insurance coverage criteria for meniscal allograft transplantation (MAT) are sufficiently supported in the policy documentation and whether these criteria represent current research and expert consensus on indications for the procedure.

Design

The top 11 United States (US)-based national commercial health insurance payers for MAT were identified. A Google search was performed to identify payer coverage policies. Cited references within policy documents were classified by type of reference and reviewed for level of evidence (LOE). Specific coverage criteria for each individual payer were then extracted and compared to assess for similarities among commercial payers. Finally, all references cited were examined to determine whether they supported the coverage criteria stated by policies for each specific payer.

Results

Seven of the 11 payers had accessible coverage policies. This study found that the majority of cited references were primary journal articles (20, 57.1%) and that the vast majority of references cited (27, 77.1%) were level IV evidence. Of the seven payers, only two (Cigna = 8, HCSC = 19) cited more than six sources. There was a high degree of homogeneity in coverage criteria among payers. The sources cited did not consistently support specific payer coverage criteria. Payer criteria also tended to be arbitrary and poorly supported by current evidence on MAT.

Conclusion

This study demonstrates that insurance coverage policies for MAT frequently use outdated references or cite references inappropriately. In addition, these policies fail to reflect current research and consensus on indications for the procedure.

Keywords

meniscal allograft transplantation commercial payer coverage policy coverage criteria indications references

Introduction

The menisci function to disperse load within the knee and radially resist shear force.¹ Loss of menisci through injury or meniscectomy results in increased contact stress.² Therefore, in young patients with an irreparable, nonfunctional or absent meniscus, meniscal allograft transplantation (MAT) is a treatment option that has been found to alleviate knee pain, improve knee function, and result in good patient satisfaction.³ A study performed from 2005 to 2014 found that the incidence of MATs performed in New York State increased about 15.5% every year.⁴ As MAT becomes more prevalent, it is important that patients who can benefit from the procedure are able to get it covered by insurance.

Many strategies have been employed by public and private insurance payers to control the costs of medical procedures. The 2006 Tax Relief and Health Care Act gave the Centers for Medicare and Medicaid Services (CMS) the power to retrospectively investigate insurance claims for previously performed procedures to ensure that they were medically necessary. It also allowed them to retroactively demand repayment for procedures deemed unnecessary. As private payers do not have this power, they must resort to prospectively endorsing restrictive coverage criteria to reduce caseloads for a given procedure and cut costs. However, if insurance company coverage criteria are backed by poor evidence or do not align with current indications for the procedure, patients may be improperly denied coverage, experience delays in surgical management, and receive inequitable or substandard care. Previous studies in the total joint arthroplasty (TJA) and shoulder arthroplasty literature have found that commercial payers tend to cite studies with low level of evidence (LOE) and that fail to mention the efficacy of conservative treatment.^5
-7 However, no publications have reported on the LOE for studies cited within commercial payer coverage policies for MAT.

The aim of this study was to analyze the references used to support commercial payer coverage policies for MAT in the United States, determine the LOE of these references, and quantify whether specific payer coverage criteria are supported by the cited publications within their coverage policies. We hypothesized that commercial payers would cite outdated studies with low LOE and that the cited studies would fail to adequately support the coverage criteria outlined within individual coverage policy documents. A secondary goal of this study was to compare coverage policies to the current research to explore if their criteria reflect evidence within the literature.

Methods

The top 11 U.S.-based national commercial health insurance payers for MAT were identified. A Google search was performed for each payer to find publicly available coverage policies pertaining to MAT. For policies unable to be found online, a phone call and email was sent to the company asking for coverage policy for MAT. A standardized review process was implemented for each policy. Policy documents were examined for references supporting coverage policies. Any reference cited directly in the policy document was included for review. Any reference cited under a specific MAT section of the document was also included. References listed at the end of the document were screened by title and/or abstract as needed for relevance to MAT (as policy documents frequently cover multiple procedures). Selected references were then classified by type of reference, reviewed for LOE per accepted published criteria.⁸ References were classified into the following types of references: primary journal article, review article, expert opinion article, society guideline, governmental report or guideline, website, textbook, miscellaneous, or not found.

Commercial payer policy documents were then further examined to extract the specific coverage criteria for each individual payer. Criteria were compared to assess for similarities among commercial payers. Finally, all references cited by each payer were again examined to determine whether they mentioned the specific payer criteria.

Results

Overall

The MAT coverage policies and associated references were obtained for seven commercial payers (Aetna, Anthem, Centene, Cigna, Health Care Services Corporation (HCSC), Humana, United Healthcare).^9
-14 The four remaining payers (Highmark, Kaiser Permanente, UPMC Health Plan, and WellCare Health Plans) did not have publicly available coverage policies and did not respond to phone calls or emails. Forty-four references were selected after screening of coverage. Nine references did not have a full-text available leading to a total of 35 references analyzed. Of the 35 articles, 20 (57.1%) were classified as primary journal articles, eight (22.9%) were classified as review articles, four (11.4%) were classified as society guidelines, two (5.7%) were classified as websites, and one (2.9%) was classified as miscellaneous ( Table 1 ). LOE was level I in one (2.9%) references, level II in one (2.9%) reference, level III in three (8.6%) references, level IV in 27 (77.1%) references, level V in 0 references, and unable to be ascertained in three (8.6%) references ( Table 2 ). Mention of efficacy of nonoperative management was found in only four (11.4%) references ( Table 3 ).

Table 1.

Reference Types by Payer and in Sum.

Commercial payer	Total references	Primary journal articles	Review articles	Society guidelines	Government report/guideline	Website	Textbook	Miscellaneous
Aetna	6	3	3	0	0	0	0	0
Anthem	2	0	0	2	0	0	0	0
Centene	4	1	0	1	0	1	0	1
Cigna	8	8	0	0	0	0	0	0
HCSC	19	12	5	1	0	1	0	0
Humana	1	0	0	0	0	1	0	0
United Healthcare	5	0	3	0	0	1	0	1
Totals (%)	35	20 (57.1%)	8 (22.9%)	4 (11.4%)	0 (0.0%)	2 (5.7%)	0 (0.0%)	1 (2.9%)

Table 2.

Reference Level of Evidence by Payer and in Sum.

Commercial payer	LOE I	LOE II	LOE III	LOE IV	LOE V	Unable to be determined
Aetna	0	0	0	6	0	0
Anthem	0	0	0	2	0	0
Centene	0	0	1	1	0	2
Cigna	1	0	1	6	0	0
HCSC		1	1	16	0	1
Humana
United Healthcare	0	0	3	0	0	2
Totals (%)	1 (2.9%)	1 (2.9%)	3 (8.6%)	27 (77.1%)	0 (0%)	3 (8.6%)

Table 3.

Tabulation of References by Whether or Not They Mention the Efficacy on Nonoperative Management.

Commercial payer	Yes	No
Aetna	0	6
Anthem	0	2
Centene	1	3
Cigna	1	7
Health Care Services Corporation	1	18
Humana
United Healthcare	0	5
Totals (%)	3 (6.81%)	41 (93.2%)

Coverage Policy Criteria

A high degree of homogeneity in coverage criteria was found among commercial payers. A summary of common included criteria is presented in ( Table 4 ). The exact coverage policies can be found within the supplementary materials. Six (85.7%) policies included age limitations of either younger than age 50 or younger than age 55. Normal alignment was required by six (85.7%) of policies. Four (57.1%) policies had body mass index (BMI) requirements, of which three required a BMI of 35 kg/m² or less and one required a BMI of 40 kg/m² or less. All policies included requirements of minimal to absent degenerative changes (Outerbridge grade of II or less). Each policy also included a requirement of the patient’s failure of conservative treatment, two of which (Humana & Cigna) required a trial of at least 3 months. Anthem noted that an exception to the requirement of a trial of physical therapy was an unusual circumstance.

Table 4.

Inclusion of Common Coverage Criteria by Commercial Payer.

Criteria	Aetna	Anthem	Centene	Cigna	HCSC	Humana	United Healthcare
Pain refractory to conservative treatment	X	X	X	X	X	X	X
Absence or near absence of meniscus	X	X	X	X	X	X	X
Outerbridge grade II or less	X	X	X	X	X	X	X
Age Criteria	X	X	X	X	X	X
BMI Criteria			X	X	X	X
Stable knee or corrected	X	X				X	X
Normal alignment or corrected	X	X	X		X	X	X

Aetna

Aetna’s coverage policy for “Allograft Transplants of the Extremities” included 121 references at the end of the document. After title and abstract screening, nine references were relevant to MAT. Three references had no full-text available, leaving six references for final analysis.^15
-20 The six sources cited by Aetna were published between 1995 and 2006. Three (50%) references were classified as review articles and three (50%) references were classified as primary journal articles ( Table 1 ). LOE was level IV for all six (100%) references ( Table 2 ). No reference mentioned the efficacy of nonoperative modalities ( Table 3 ). Aetna and other payer coverage criteria for MAT can be found in Table 5 along with the number and percent of references that mention specific payer criteria. No in-text citations were given within the MAT section.

Table 5.

Number and Percent of References Cited By Each Payer That Mention Their Specific Coverage Criteria.

Aetna	Significant pain unresponsive to conservative treatment	Absence or near-absence of meniscus	Degenerative changes absent/minimal	<55 years		Knee stable or corrected at time of allograft	Normal knee alignment or corrected at time of allograft
#	6.00	5.00	5.00	5.00		4.00	4.00
%	1.00	0.83	0.83	0.83		0.67	0.67
Anthem	Pain refractory to conservative treatment		Mild-moderate articular damage	<55 years		Ligamentous stability	Normal alignment
#	0.00		0.00	0.00		0.00	0.00
%	0.00		0.00	0.00		0.00	0.00
Centene	Pain refractory to conservative treatment	missing >50% meniscus or unable to repair	Mild-moderate articular damage	<55 (young and active)	BMI < 35		Normal alignment	No systemic degenerative disease
#	2.00	2.00	3.00	2.00	1.00		2.00	0.00
%	0.50	0.50	0.75	0.50	0.25		0.50	0.00
Cigna	Function-limiting pain	Irreparable meniscal tear or >50% meniscal loss	No severe osteoarthritis	<50 years	BMI < 35
#	3.00	3.00	4.00	2.00	0.00
%	0.38	0.38	0.50	0.25	0.00
HCSC	Disabling knee pain refractory to conservative treatment	Prior meniscectomy w/symptoms	Minimal to absent degenerative changes	<55 years/too young for TKA	BMI < 35	Normal knee biomechanics, alignment, stability (or concurrently done)		No infection, inflammatory arthritis, synovial disease
#	15.00	15.00	16.00	12.00	4.00	15.00		4.00
%	0.79	0.79	0.84	0.63	0.21	0.79		0.21
Humana	Disabling knee pain refractory to conservative treatment (3 months)	Absence or near-absence of meniscus	Outerbridge 2 or less	<50 y/o	BMI < 40	Normal knee stability (or concurrently done)	Normal alignment
#		0	0	0	0	0	0
%		0.00	0.00	0.00	0.00	0.00	0.00
United	Disabling knee pain refractory to conservative treatment	absence of >50% meniscus or irreparable tear	Minimal to absent degenerative changes			Normal alignment or correctable		No active inflammatory arthritis or systemic arthritis
#	4.00	4.00	4.00			4.00		1.00
%	0.80	0.80	0.80			0.80		0.20

Anthem

Anthem’s coverage policy for “Joint Surgery” referenced two sources at the end of their MAT section; however, both were on the subject of anterior cruciate ligament surgery. References were from 2009 and 2015.^21,22 LOE was level IV for both references ( Table 2 ). No in-text citations were given within the MAT section.

Centene

Centene’s coverage policy for “Articular Cartilage Defect Repairs” included 31 references at the end of the document. After title and abstract screening, a total of four references were selected for analysis.^23
-26 Cited sources were published between 2011 and 2022. Article type and mention of efficacy of nonoperative treatment can be found in Tables I and III, respectively, for all payers. LOE was level III for one (25%) reference, level IV for one (25%) reference, and unable to be determined in two (50%) references ( Table 2 ). The one reference cited in-text was a webpage and cited accurately.

Cigna

Cigna’s policy for “Musculoskeletal Knee Surgery: Arthroscopic and Open Procedures” included 155 references at the end of the document. After title and abstract screening of all references, eight were included for analysis.^19,20,27
-32 Included references were published between 1989 and 2018. LOE was level I for 1 (12.5%) reference, level III for 1 (12.5%) reference, and level IV for 6 (75.0%) references ( Table 2 ). No in-text citations were given within the MAT section.

Health Care Services Corporation

Health Care Services Corporation’s policy entitled “Meniscal Allografts and Other Meniscal Implants” cited 29 references at the end of the document with 19 included in the text of the MAT section. After screening of the rest of the references, only the 19 references cited in-text were found to be relevant and included for analysis.^33,24,33
-49 Cited references were published between 2005 and 2021. LOE was level II for one (5.3%) reference, level III for one (5.3%) reference, level IV for 16 (84.2%) references, and unable to be determined for one (5.3%) reference ( Table 2 ). All references were cited accurately.

Humana

In its document “Allograft Transplantation of the Knee” Humana cited 20 references at the end of their policy. Of the five references that were applicable to MAT, four were archived and not accessible. The one accessible source was an UpToDate, Inc. webpage entitled “Meniscal injury of the knee.” No references were cited directly within the MAT section.

United Healthcare

United Healthcare’s coverage policy for “Meniscus Implant and Allograft” included 18 references at the end of the document. After screening, five references were found to be relevant to MAT.^{3,23,24,34,50} They were published between 2010 and 2021. LOE was level IV for 3 (60%) of the references and unable to be determined for 2 (20%) of the references (Table 2). Four references were cited in-text, and all were cited accurately.

Discussion

This study found that commercial payers often cite poor quality, too few, or out of date sources and that they rarely cite references properly in their coverage policies. We found that approximately half of cited references were primary journal articles and that the vast majority of references cited were level IV evidence. Of the seven included payers in this analysis, only two cited more than six sources. In addition, for four out of the seven commercial payers analyzed less than 50% of the cited sources mentioned the payer’s specific coverage criteria. Given these findings, it appears that the included commercial payers have based their policies on arbitrary and outdated recommendations surrounding the use of MAT.

Our findings are consistent with prior literature on coverage polices for other procedures. A 2021 study by Austin et al.⁵ in the TJA literature found that of the 282 documents reviewed, 45.8% were primary journal articles, 14.2% were level I or II evidence, and only 41.2% were applicable to patients who were candidates for TJA. A similar study by Sudah et al.⁷ in the total shoulder arthroplasty literature found the most common reference type cited by commercial payers was primary journal article (n = 70; 59.3%) and that most references were of level IV evidence (n = 60; 52.2%), with only six (5.2%) of level I or II evidence. Of the references analyzed in our study, only one was level I and one was level II. This is despite the fact that there have been many level II studies on MAT published recently.^44,51
-53

When examining the appropriateness of insurance coverage criteria, it is important to consider the modern indications for MAT.⁵⁴ The traditional indication for MAT is a symptomatic meniscal deficiency in the absence of osteoarthritic changes in the knee, while lower extremity malalignment and/or other pathology—such as focal chondral defects or ligamentous instability—are addressed concomitantly. Six payers include a criterion of correcting knee stability at the time of MAT and the importance of a functional meniscus in ligamentous reconstruction is well-supported in the literature.^55,56 The deleterious biomechanical effects of meniscal deficiency are established and while it is common practice for meniscal tears to undergo a trial of conservative therapy, severe or complete meniscal deficiency is unlikely to be amenable to non-operative management.^57
-59 Every coverage policy analyzed here included a requirement for a failure of conservative treatment, with more than three months of trialing required by two policies. However, attempting prolonged conservative management and/or delaying operative treatment of severe meniscal deficiency may predispose cartilage damage and can jeopardize clinical outcomes after MAT, especially in the setting of ligamentous insufficiency.^58,60 Both of these studies were published during the current decade and Cigna, one of the policies requiring a three-month trial of conservative management, only uses references updated through 2018. By failing to incorporate more modern research, this policy may risk outcomes and prolong patient pain. This also jeopardizes future coverage, as severe cartilage damage is considered an exclusion criterion by all policies included.

Preoperative cartilage damage is one aspect of coverage criteria that remains poorly supported and does not align well with current indications for MAT. Defining the acceptable amount of preoperative cartilage damage in MAT candidates continues to be an important point of debate. All seven payers analyzed have a criterion specifying that MAT only be performed on knees with mild to moderate degenerative changes (Outerbridge grade II or less). Like the International Cartilage Repair Society (ICRS) grading system, the Outerbridge grading system is designed as a classification system for focal chondral defects rather than global degenerative changes.⁶¹ Recent studies have demonstrated that patients with moderate to severe (Outerbridge grade III or IV or ICRS grade III or IV) focal chondral defects can achieve acceptable clinical outcomes following MAT.^62
-64 Stone et al.⁶⁴ reported a 73% return to sport rate in 49 patients who underwent MAT and who had Outerbridge grade III or IV chondral defects in their knee. Another study reported no difference in the clinical outcomes after MAT between patients with high-grade (ICRS grade III or IV) cartilage lesions of both the femur and tibia compared to patients with high-grade lesions on just one side of the joint or those who had low-grade (ICRS grade II or less) lesions of both the femoral and tibial cartilage.⁶² Of note, in this study only 26 of 135 patients with high-grade cartilage lesions underwent prior or concomitant cartilage restoration procedures.⁶² While surgeons should still hesitate to perform MAT in a knee with global high-grade degenerative changes, the presence of high-grade focal lesions likely should not be considered an absolute contraindication to MAT especially if accompanied by a concomitant cartilage restoration procedure.

Like cartilage damage, specific patient age indications remain controversial. All payers except for United Healthcare have an age criteria: Cigna and Humana require patients to be <50 years old; Aetna, Anthem, Centene, and HCSC require patients to be <55 years old. However, some evidence supports MAT effectiveness in older patients. A 2019 study by Zaffagnini et al.⁶⁵ found no difference in mean survival time free from replacement or graft removal between patients older than 50 (11.6 years) and younger than 50 (12.3 years) (p = 0.691). They also found that at a mean follow-up of 7.3 years patients in the older group had improved Lysholm, Tegner and Visual Analogue Scale (VAS) compared to preoperatively.⁶⁵ These results indicate that restrictive age criteria may be limiting the number of patients who might benefit from the procedure. Although difficult to quantify, physiologic age remains a more important consideration than chronological age. Older active patients with relatively healthy knees may be appropriate candidates for MAT.

It is important to note that more research is required to decisively determine the efficacy of MAT for various kinds of patients. The amount of high-quality evidence in support of MAT and defining the best patients for MAT is still limited. Future studies, like that proposed by Arnold et al.⁶⁶ aiming to assess the clinical and cost-effectiveness of MAT compared to rehabilitation, will help provide more high-quality evidence that allows the orthopedic sports community to decipher which patients should undergo MAT. It will be important that insurance payers continue to update policies based on newer, higher-quality research to ensure they are supporting their policyholders in receiving the best evidence-based care.

This study suggests that insurance coverage criteria for MAT are outdated and arbitrary. One explanation could be rapidly evolving evidence on the subject. Nevertheless, MAT candidates may be falsely denied coverage⁶⁰ and thus it is important for insurance companies to revise their coverage policies on MAT based on current evidence and the modern indications for the procedure as described above. In particular, using a percentage (usually 50%) of meniscal deficiency to determine coverage is arbitrary and not supported in the literature. Rather than employing a specific numerical cutoff, coverage criteria may be able to better select appropriate patients by focusing on the concept of symptomatic, functional meniscal deficiency. This is because multiple factors combine to determine the level of disability caused by meniscal injury including the location and severity of the injury, duration and characteristics of symptoms, functional demands for daily activities or sports, other comorbidities, and previous injuries. Therefore, it is the obligation of insurance companies to not only update their current coverage criteria for MAT using newer findings within the literature but also to consider other factors that make patients appropriate MAT candidates before they determine coverage.^60,67 As research evolves, the indications for MAT are expected to broaden and insurance companies must embrace the challenge of updating their policies on the basis of current evidence.

This study had several limitations. First, we could not find the coverage policies for four of the 11 commercial payers investigated (Highmark, Kaiser Permanente, UPMC Health Plan, and WellCare Health Plans). Nevertheless, the seven included payers cover around 200 million patients in the United States and thus the results are applicable to a large percentage of the country’s population. Second, we could not access nine of the references cited in the coverage policies investigated as there was no full-text for these studies; however, the vast majority were accessible. Finally, conclusions based on LOE were limited in their scope by a paucity of high LOE research on outcomes following MAT. Such a finding highlights the need for future prospective trials investigating MAT.

Conclusion

The results of this study demonstrate that insurance coverage policies for MAT use references poorly or inappropriately and that even when cited properly these policies fail to reflect current research and consensus on indications for the procedure. It is thus possible that there are patients who might benefit from MAT who would be denied insurance coverage without proper justification. We recommend that commercial coverage policies be adjusted to better incorporate current research on MAT. We also recommend that a shared decision-making process be used when considering MAT so that patients who can benefit from the procedure are able to access care that will improve their quality of life.

Supplemental Material

sj-docx-1-car-10.1177_19476035251329223 – Supplemental material for Commercial Insurance Payer Coverage Criteria for Meniscal Allograft Transplantation Poorly Reflect Modern Indications for the Procedure

Supplemental material, sj-docx-1-car-10.1177_19476035251329223 for Commercial Insurance Payer Coverage Criteria for Meniscal Allograft Transplantation Poorly Reflect Modern Indications for the Procedure by Jacob L. Kotlier, Amir Fathi, Meng-Yung Ong, Cailan L. Feingold, Eric H. Lin, Ryan D. Freshman, Ioanna K. Bolia, Frank A. Petrigliano and Joseph N. Liu in CARTILAGE

Footnotes

Acknowledgment and Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethical Approval

This study did not involve human subjects and therefore did not require institutional review board (IRB) approval.

ORCID iDs

Jacob L Kotlier

Amir Fathi

Supplementary material for this article is available on the Cartilage website at .

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