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                              In re LCD Complaint: Hyaluronan Acid Therapies for Osteoarthritis of the Knee (L35427), DAB CR6001 (2021)
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In re LCD Complaint: Hyaluronan Acid Therapies for Osteoarthritis of the Knee (L35427), DAB CR6001 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





*In re* Local Coverage Determination Complaint:
Hyaluronan Acid Therapies for Osteoarthritis of the Knee (L35427)

Contractor:  Novitas Solutions, Inc.,
Medicare Administrative Contractor, Jurisdictions H, L
Docket No. C-19-1132Decision No. CR6001December 16, 2021

        
              
    

      DECISION

The Local Coverage Determination (LCD) record for LCD L35427, Hyaluronan Acid Therapies for Osteoarthritis of the Knee, is complete and adequate to support the validity of the LCD provisions at issue under the reasonableness standard.  The LCD provisions at issue1
 provide that:

A repeat series2
 of hyaluronan knee injections are reasonable and necessary only when at least six months have elapsed since the prior series of injections. CMS Ex. 1 at 6.Page 2

A repeat series of hyaluronan injections initiated fewer than six months after the completion of the previous series of injections is not medically reasonable or necessary. CMS Ex. 1 at 8.Review of the challenged provisions of LCD L35427 is complete with the issuance of this decision, and the Aggrieved Party is entitled to request further review by the Appellate Division of the Departmental Appeals Board (Board).

I.  Background

On September 10, 2019, the Aggrieved Party3
 filed a Complaint4
 pursuant to 42 C.F.R. pt. 426 requesting review of the following LCDs:

LCD L35427, Hyaluronan Acid Therapies for Osteoarthritis of the Knee, issued by Novitas Solutions, Inc., a Medicare Administrative Contractor (MAC) (eff. Oct. 1, 2015, rev. Oct. 1, 2019); and

LCD L33318, Knee Orthoses, issued by CGS Administrators, LLC, a Durable Medicare Equipment (DME) MAC (eff. Oct. 1, 2015, rev. Jan. 1, 2019).

The Aggrieved Party further requested coverage for four platelet rich plasma (PRP) injections for each knee annually.  He acknowledged that there is no LCD related to PRP injections subject to my review.  Complaint at 1, DAB E-File #1.

Page 3

The Complaint was assigned to me and an acknowledgment was sent to the Aggrieved Party on October 7, 2019.  In the acknowledgment, I advised the Aggrieved Party that he had not filed an acceptable complaint under the applicable regulations.  I also advised the Aggrieved Party that he had not provided a citation to an LCD that was relevant to his assertions regarding PRP injections.  I advised the Aggrieved Party that he had one opportunity to file an acceptable complaint and that he must send a copy of the amended complaint to the addressees listed in the letter.

On October 27, 2019, the Aggrieved Party filed a response to the acknowledgment, with multiple documents filed in DAB E-File described as “P. Ex.” 1 through “P. Ex.” 8, though the documents bear no markings on their faces.  DAB E-File ##4-16.  The documents filed on October 27, 2019, are treated as the Aggrieved Party’s amended complaint.

On December 12, 2019, I issued an “Acknowledgment of Receipt of Acceptable Complaint As To LCD L35427, Order to File LCD Record for LCD L35427, and Briefing Schedule; and Dismissal of Complaint as to LCD L33318” (Acknowledgment and Order).  I dismissed the Complaint as to LCD L33318, as the Aggrieved Party did not provide a physician’s statement of need for new knee braces, as required by 42 C.F.R. § 426.400(c)(3), despite having had one opportunity to correct the Complaint.  Acknowledgment and Order ¶ III (citing 42 C.F.R. § 426.444(b)(4)).5
  I also determined that the Aggrieved Party did not refer to the PRP injections in the amended complaint and, therefore, I treated as withdrawn his allegations concerning PRP injections made in the original complaint.  Acknowledgment and Order ¶ II.  I evaluated the Complaint as required by 42 C.F.R. § 426.410(b)-(d) and found the Complaint acceptable.6
  Acknowledgment and Order ¶ II.

Page 4

On January 10, 2020, Novitas filed the LCD record for L35427, marked as CMS Exhibit (Ex.) 1.7
   DAB E-File ##19-23.

My Acknowledgment and Order required that the Aggrieved Party file his statement authorized by 42 C.F.R. § 426.425(a) no later than February 10, 2020.  Because the Aggrieved Party failed to file his statement, on March 2, 2020, I ordered that the Aggrieved Party show good cause for not filing his statement by February 10, 2020.  DAB E-File #27.

On March 9, 2020, the Aggrieved Party filed his response to the Order to Show Cause, consisting of two documents described in DAB E-File as P. Ex. 9 and P. Ex. 10.  DAB E-File ##28-28a.  I treat P. Ex. 9 (DAB E-File #28) as the Aggrieved Party’s statement authorized by 42 C.F.R. § 426.425(a).  On March 11, 2020, I issued an order discharging the Order to Show Cause and ordering Novitas to file its response under 42 C.F.R. § 426.425(b).  On April 9, 2020, Novitas filed its response to the Aggrieved Party’s statement.  DAB E-File #30.

Page 5

On April 27, 2020, and on September 15, 2020, the Aggrieved Party filed sur-replies to Novitas’ response marked as P Exs. 11 through 13.  DAB E-File ##32-34.

CMS Ex. 1, the LCD record for L35427, is admitted and considered as evidence.  All documents submitted by the Aggrieved Party in support of the Complaint are admitted and considered as evidence.  DAB E-File ##5-16 (P. Exs. 1-8), 28-28a (P. Exs. 9‐10), 32-34 (P. Exs. 11-13), and 35 (listed in DAB E-File and marked as P. Ex. 13).

II.  Discussion

**Applicable Law**Section 1831 of the Social Security Act (the Act) (42 U.S.C. § 1395j), establishes the supplementary medical insurance benefits program for the aged and the disabled known as Medicare Part B.  Qualified individuals must elect to participate in the Medicare Part B program, which is funded by an enrollee’s premiums and appropriations from the federal government.  The coverage or benefits of Medicare Part B are described in sections 1832, 1833, and 1834 of the Act (42 U.S.C. §§ 1395k, 1395*l*, and 1395m).  Section 1862 of the Act (42 U.S.C. § 1395y), which is applicable to both Medicare Part A and Part B, provides that no payment may be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illnesses or injury or to improve the functioning of a malformed body member . . . .”  The Secretary of the Department of Health and Human Services (Secretary) has provided by regulation 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 Medicare Benefit Policy Manual, CMS Pub. 100-02, ch. 16, §§ 10 and 20 (rev. 198, eff. Jan. 1, 2015 and rev. 1, eff. Oct. 1, 2003, respectively), provide that no payment can 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.8

Medicare Part B is administered through the MACs.  Act §§ 1842, 1874A (42 U.S.C. §§ 1395u, 1395kk-1).  The Act provides for both National Coverage Determinations (NCDs) and LCDs.  Act § 1869(f)(1)(B) and (2)(B) (42 U.S.C. § 1395ff(f)(1)(B) and (2)(B)).  An LCD is a determination by a MAC applicable to the area served by the contractor as to whether or not a particular item or service is reasonable and necessary within the meaning of section 1862(a)(1)(A) of the Act and covered by Medicare.  Act § 1869(f)(2)(B); 42 C.F.R. § 400.202.

Page 6

*Local coverage determination (LCD)*means a decision by a fiscal intermediary or a carrier under Medicare Part A or Part B, as applicable, whether to cover a particular service on an intermediary-wide or carrier-wide basis in accordance with section 1862(a)(1)(A) of the Act.  An LCD may provide that a service is not reasonable and necessary for certain diagnoses and/or for certain diagnosis codes.  An LCD does not include a determination of which procedure code, if any, is assigned to a service or a determination with respect to the amount of payment to be made for the service.

42 C.F.R. § 400.202.

Pursuant to section 1862(*l*)(5)(D) of the Act (42 U.S.C. § 1395y(*l*)(5)(D)), the Secretary must require the MACs who issue LCDs to make them available on the MAC and CMS websites, including the full text of the LCD; access by hyperlink to the proposed LCD and responses to comments submitted to the MAC regarding the proposed LCD; a summary of evidence considered by the MAC and a list of the sources of the evidence; and an explanation of the rationale that supports the LCD.

In the absence of an NCD or an LCD, individual claims determinations are made based upon an individual beneficiary’s particular fact situation.  68 Fed. Reg. 63,692, 63,693 (Nov. 7, 2003) (citing *Heckler v. Ringer*, 466 U.S. 602, 617 (1984) (recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication)); 42 C.F.R. §§ 426.420(a), (b), (e)(1), 426.460(b)(1), 426.488(b).

Review of an LCD is distinct from review of an individual claim determination.  68 Fed. Reg. at 63,692-94; 42 C.F.R. § 426.310(a) (individual claims appeals processes are established by 42 C.F.R. pt. 405 subpts. G and H, pt. 417 subpt. Q, and pt. 422 subpt. M).  The right to administrative and judicial review of individual claims determinations is established by sections 1869(a) through (d) of the Act (42 U.S.C. § 1395ff(a) through (d)), and the regulations of the Secretary governing review are at 42 C.F.R. §§ 405.1000 through 405.1140.  Individual claims determinations are not subject to review under the LCD process.  68 Fed. Reg. at 63,707.  Pursuant to the Act and the Secretary’s implementing regulations, the Board has the authority to review NCDs; ALJs assigned to the Civil Remedies Division of the Board have the authority to review LCDs, subject to further review by the Board; and individual claims determinations are reviewed by ALJs

Page 7

assigned to the Office of Medicare Hearings and Appeals (OMHA), subject to further review by the Medicare Appeals Council.9

Section 1869(f)(2)(A) of the Act10
 provides for the review of an LCD by an ALJ, as follows:

(2) Local Coverage Determination. –

(A) In General. – Review of any local coverage determination shall be subject to the following limitations:

(i) Upon the filing of a complaint by an aggrieved party, such determination shall be reviewed by an administrative law judge.  The administrative law judge. –

(I) shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, **if the administrative law judge determines that the record is incomplete or lacks adequate information to support the validity of the determination**;

(II) may, as appropriate, consult with appropriate scientific and clinical experts; and

Page 8

(III) shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.

Act § 1869(f)(2)(A)(i) (42 U.S.C. § 1395ff(f)(2)(A)) (emphasis added).  An aggrieved party may request that the Board review an adverse ALJ determination.  Act § 1869(f)(2)(A)(ii).

An aggrieved party is one who has standing within the meaning of section 1869(f)(5) of the Act (42 U.S.C. § 1395ff(f)(5)):

An action under this subsection seeking review of a national coverage determination or local coverage determination may be initiated only by individuals entitled to benefits under part A, or enrolled under part B, or both, who are in need of the items or services that are the subject of the coverage determination.

The Secretary promulgated regulations pursuant to sections 1102 and 1871 of the Act (42 U.S.C. §§ 1302 and 1395hh), implementing sections 1869(f)(1) and (f)(2) of the Act for the review of NCDs and LCDs.  68 Fed. Reg. at 63,692; 42 C.F.R. § 426.100.  The regulations are found at 42 C.F.R. pt. 426.  The procedures for review of an LCD are in 42 C.F.R. pt. 426, subpt. D (42 C.F.R. § 426.400 *et. seq.*).  The regulatory history for the regulations states that the regulations expanded the definition of an aggrieved party “to include a beneficiary who received a service, but whose claim for the service was denied extending an opportunity to that beneficiary” to file a complaint for an NCD or LCD review.  68 Fed. Reg. at 63,693.

Section 1869(f)(2) of the Act establishes a two-phase LCD review process by the ALJ.  In the Phase I review, the ALJ reviews the LCD record and, if he or she determines that the record is complete with adequate information to support the validity of the LCD, review is complete.  If the ALJ reviews the record and determines that the record is incomplete or lacks adequate information to support the validity of the LCD, then further process is required, including discovery and the taking of evidence, at an oral hearing if necessary.

The Secretary’s regulations establish a review procedure consistent with that specified by Congress.  The regulations provide that after an aggrieved party files a statement as to

Page 9

why the LCD is not valid11
 and the contractor responds, “the ALJ applies the reasonableness standard to determine whether the LCD record is complete and adequate to support the validity of the LCD.”  42 C.F.R. § 426.425(c)(1).  “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).  If the ALJ determines that the LCD record is not complete and adequate to support the validity of the LCD, then the regulation provides for discovery and the taking of additional evidence.  42 C.F.R. § 426.425(c)(3).  No hearing was intended by the drafters or required by the language of the regulation for the first phase review.  68 Fed. Reg. at 63,700, 63,710.

The reasonableness standard is defined at 42 C.F.R. § 426.110, as:

[T]he standard that an ALJ or the Board must apply when conducting an LCD or an NCD review.  In determining whether LCDs or NCDs are valid, the adjudicator 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 are reasonable based on the LCD or NCD record and the relevant record developed before the ALJ or the Board.

Further clarification of the reasonableness standard intended by the drafters is provided by the notice of final rulemaking at 68 Fed. Reg. at 63,703-04.  The drafters of the regulation discussed the reasonableness standard adopted as follows:

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 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 (sic), in recognition of the expertise of a program agency.  Thus, we view the statute as setting out a reasonableness standard that

Page 10

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 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. at 63,703-04*.*

Pursuant to 42 C.F.R. § 426.330, the aggrieved party bears the burdens of proof and persuasion.  The burden of persuasion is judged by a preponderance of the evidence.

Page 11

**Jurisdiction**My jurisdiction or authority is clearly delineated at 42 C.F.R. §§ 426.405, 426.450, and 426.455.  In this Phase I evaluation, I am limited to addressing the issue of whether or not the LCD record is complete and adequate to support the validity of the LCD under the reasonableness standard.  42 C.F.R. § 426.450(a).

**Issue**In Phase I of an LCD review, the issue is whether or not the LCD record is complete and adequate to support the validity of the challenged LCD provisions under the reasonableness standard.12

Whether the Aggrieved Party is actually entitled to Medicare coverage for the item or service that his physician states he requires is not an issue before me.

**Findings of Fact, Conclusions of Law, and Analysis**My conclusions of law are set forth in bold followed by the pertinent facts and analysis.

**Provisions of LCD L35427 challenged:**a.  A repeat series of hyaluronan knee injections are reasonable and necessary only when at least six months have elapsed since the prior series of injections. CMS Ex. 1 at 6.

b.  A repeat series of hyaluronan injections initiated fewer than six months after the completion of the previous series of injections is not medically reasonable or necessary. CMS Ex. 1 at 8.

**Treatment the Aggrieved Party needs that is subject to the LCD provisions challenged.**The Aggrieved Party wants Medicare to cover hyaluronan injections in his knees every three months rather than every six months.  Complaint at 1; P. Exs. 3, 4, 9, 11, DAB E-File ##10-11, 28, 32.  The Aggrieved Party filed a July 30, 2019 letter from his physician, Todd Wente, MD, that states the Aggrieved Party needs hyaluronan injections every three months.  The physician’s explanation for why he believes injections are required every

Page 12

three months is accepted as true and accurate.  P. Ex. 1, DAB E-File ##5‐6.  The Aggrieved Party also filed a letter and a record of a telephone call dated October 15, 2019, from his orthopedic surgeon, Charles A. Peterson, II, MD, explaining why joint replacement surgery to address the Aggrieved Party’s bilateral knee osteoarthritis (OA) is not an option.  P. Exs. 5, 8, DAB E-File ##12-13, 18.  I accept that the Aggrieved Party’s physicians have determined that the Aggrieved Party needs hyaluronan injections as often as every three months to address the pain associated with his bilateral knee OA and that surgical joint replacement is not an option.

However, the fact that the Aggrieved Party may have a legitimate need for care and services is not a basis for finding unreasonable an LCD that prevents Medicare coverage for needed care and services.  As explained hereafter, the Aggrieved Party’s claim may be better made in another forum.

The Aggrieved Party did not file scientific evidence in support of his complaint other than the statements of his physicians and some personal clinical records.

**Petitioner is an aggrieved party who may maintain a challenge to the LCD provisions.**The evidence shows that Petitioner filed a claim with Medicare for hyaluronan injections with a date of service of January 25, 2021, and the claim was denied March 8, 2021.  P. Ex. 13, DAB E-File #35.  42 C.F.R. §§ 426.110 (aggrieved party is entitled to Medicare benefits, needs coverage for a service denied based on an applicable LCD, and has documentation of the need from the treating physician), 426.320(a) (only aggrieved party may initiate review of LCD or provision of an LCD).  The denial of that claim is not subject to review by me.

**Based upon the evaluation required by 42 C.F.R. § 426.425(c)(1), I conclude that the LCD record is complete and adequate to support the validity of the LCD provisions at issue under the reasonableness standard.  42 C.F.R. § 426.450(a)(4).**There is one LCD at issue before me – LCD L35427.  The gist of the Aggrieved Party’s Complaint is that, in his individual case, Medicare should cover intra-articular injections of hyaluronic acid in each of his knees every three months, based on his unique and rare medical condition.  P. Ex. 11; DAB E-File Item #32.  The LCD limits injections to no more often than every six months.  CMS Ex. 1 at 7.  The issue to be decided is whether the LCD record is complete and adequate under the reasonableness standard to support the determination that intra-articular injection or a series of such injections in a knee joint is not reasonable and necessary if administered within six months of a prior injection or injections.  I conclude that the LCD record is complete and adequate to support the provisions of Novitas LCD L35427.

Page 13

The LCD history includes the following:

Hyaluronic acid, also known as hyaluronan or hyaluronate, is a naturally occurring substance found in the synovial fluid surrounding joints.  Osteoarthritic joints are found to have lower concentrations of hyaluronic acid.  Intra-articular injections of hyaluronic acid, also known as viscosupplementation, has been proposed as a means of restoring the normal viscoelasticity of the synovial fluid in individuals with osteoarthritis.

CMS Ex. 1 at 6.13
   The LCD generally provides that viscosupplementation therapy for the knee, through intra-articular injections, is reasonable and necessary when the patient is symptomatic, the diagnosis is supported by radiologic evidence of OA in the knee, other potential diagnoses have been ruled out through diagnostic assessment and testing, the patient has “failed at least three months of conservative therapy” such as exercise or simple analgesics, and the patient has not responded to aspiration of the knee and intra-articular corticosteroid injection therapy when indicated. 14
   CMS Ex. 1 at 6-7.

With respect to frequency of injections, the LCD provides as follows:

A **repeat series*** of hyaluronan knee injection(s) for patients who have responded to a prior series is considered to be reasonable and necessary under the following circumstances:

Symptoms have recurred**And,**
	*At least six months have elapsed since the prior series of injections***And,**Page 14

There was significant improvement in pain and functional capacity achieved with the prior series of injections using a standardized assessment tool**Or**,
	There is significant reduction in the doses of NSAID medications taken or reduction in the number of intra‐articular steroid injections to the knees *during the six‐month period following the injection(s)*.***Note**:  A series is defined as a set of injections for each joint and each treatment (initial or repeat).

CMS Ex. 1 at 7 (emphasis added).  Under “Utilization Guidelines,” the LCD states that, based on the hyaluronan preparation used, a series of injections may consist of one intra‐articular injection per knee or a series of two to five weekly injections.  CMS Ex. 1 at 14.  The LCD provides that the Synvisc One® hyaluronan preparation, which the Aggrieved Party has requested in this case, consists of a “[s]ingle injection per knee.”  CMS Ex. 1 at 15.  In an explanatory note, the LCD states that “[t]he duration of treatment per series is from the FDA medication package insert full prescribing information.”  CMS Ex. 1 at 15.

The LCD indicates that Novitas based the LCD on evidence consisting of a Technology Assessment Systematic Review, Evidence-Based Guidelines, and Published Literature.  CMS Ex. 1 at 10-13, 15-17 (Bibliography).  In its Analysis of Evidence, Novitas states that “[v]arious polymers of hyaluronic acid have been approved and marketed as implanted prosthetic devices.”  CMS Ex. 1 at 13.  Novitas observes that clinical practice guidelines provided conflicting recommendations for using intra-articular hyaluronic acid treatment for OA in the knees.  CMS Ex. 1 at 13.  Technology assessment reviews demonstrated “a small, statistically significant effect of HA [hyaluronic acid] on function.”  CMS Ex. 1 at 13.  Clinical studies showed that intra-articular injections of forms of hyaluronic acid into the knee were “sometimes marginally more effective than placebo procedures” in reducing pain and improving functioning “in some patients.”  CMS Ex. 1 at 13.  Novitas cautioned that there was no evidence to support that hyaluronic acid agents either reversed or retarded the OA process where injected and that the long-term effects of repeated injections were unknown.  CMS Ex. 1 at 13.  Novitas’ description of the evidence it considered related to intra-articular injections of hyaluronic acid into the knees is not disputed.

The LCD record includes evidentiary support for the reasonableness of the challenged LCD provisions.  The evidentiary support includes position papers of recognized organizations with pertinent expertise, learned articles, and clinical practice guidelines.

Page 15

I summarize here the persuasive and credible evidence from the LCD record which shows that the LCD record is complete and adequate under the reasonableness standard.

*FDA Label*

The LCD Record contains the FDA premarket approval (PMA) of Synvisc® Hylan G-F 20 dated August 8, 1997.  The PMA states that Synvisc® Hylan G-F 20 was approved for the treatment of knee pain due to OA in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics.  CMS Ex. 1 (pt. 1) at 244‐49.  The LCD Record also contains FDA label information for Synvisc® Hylan G‐F 20 (CMS Ex. 1 (pt. 1) at 250-51) and Synvisc® One Hylan G-F 20 (CMS Ex. 1 (pt. 1) at 252-56.  Both labels indicate that Synvisc® is indicated for treatment of knee pain due to OA in patients who have not responded adequately to conservative nonpharmacologic therapy and simple analgesics.  CMS Ex. 1 (pt. 1) at 250, 252.  The label for Synvisc® Hylan G-F 20 refers to three clinical studies that support its safety and effectiveness.  CMS Ex. 1 (pt. 1) at 250.  In a multicenter “randomized, double-blind prospective clinical trial with two treatment groups,” the authors concluded that the group which received three weekly intra-articular injections “showed a significantly greater improvement in all outcome measures than did the saline-treated patients over a twelve-week period.”  CMS Ex. 1 (pt. 1) at 250.  A second single-center study, which “was a concurrently controlled, randomized, double-blind prospective clinical trial with two treatment groups,” had similar results as in the first study, although with smaller significance levels.  CMS Ex. 1 (pt. 1) at 250.  A third study, which “was a prospective, concurrently controlled, randomized, double-blinded multicenter study . . . at five U.S. sites,” found “no significant differences” in patients treated with Synvisc®, when compared to patients who had received arthrocentesis over a four-week evaluation period.  CMS Ex. 1 at 250.  The FDA labels indicate that a Synvisc® injection’s primary efficacy endpoint for pain control was 26 weeks (six months).  CMS Ex. 1 (pt. 1) at 253, 255 (Tables 4, 5).

*AHRQ Technology Assessment Report (**2015)*

On July 23, 2015, the Agency for Healthcare Research and Quality (AHRQ) of the Department of Health and Human Services (HHS) published a Technology Assessment Report, titled “Systematic Review for Effectiveness of Hyaluronic Acid in the Treatment of Severe Degenerative Joint Disease (DJD) of the Knee” (Assessment).  CMS Ex. 1 (pt. 1) at 121‐243.  The assessment is based upon research conducted by the RAND Southern California Evidence-Based Practice Center and is intended to assist those in the healthcare field “make well-informed decisions and thereby improve the quality of health

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care services.”  CMS Ex. 1 (pt. 1) at 122-23.15
  The assessment was issued in response to a CMS request for “a review of the evidence that intraarticular injections of hyaluronic acid (HA) in individuals with degenerative joint disease [OA] of the knee improve function and quality of life (QoL)” and their effect on surgery for total knee replacements, particularly for patients aged 65 or older.  CMS Ex. 1 (pt. 1) at 125.  The assessment states that its authors “identified 18 randomized trials that compared the effects of HA with placebo or another HA,” using functional measurements.  CMS Ex. 1 (pt. 1) at 190.  Under “Key Points,” the assessment states that meta-analysis of ten studies found that the effects of HA treatment over “placebo control showed a significant improvement in WOMAC-assessed function . . . .”16  CMS Ex. 1 (pt. 1) at 190.  Studies with findings reported at 4 week, 6 month, and 52 week follow up points “also reported a positive effect . . . on functional outcomes.”  CMS Ex. 1 (pt. 1) at 191.  In direct comparison of two HA products, studies reported that a majority of patients met the minimum clinically important improvement in function or had “significant increases in the proportion of HA-treated patients who improved,” in comparison to patients given placebos.  CMS Ex. 1 (pt. 1) at 191.  In the discussion of key findings and evidentiary strength, the assessment made the following conclusions in three relevant categories:

(1)  *Intra-articular HA and Function.*  “The strength of evidence for the conclusion that HA, on average, modestly improves function in patients with knee OA based on placebo-controlled trials is low (trials were not all well designed and two found no effect).  The strength of evidence for the conclusion that one HA is better than another, head‐to‐head comparisons, is *insufficient*.”  CMS Ex. 1 (pt. 1) at 225 (emphasis added).

(2)  *Intra-articular HA and QoL.*  “The strength of evidence for any conclusions regarding an effect of HA on quality of life is *insufficient*.”  CMS Ex. 1 (pt. 1) at 225 (emphasis added).

(3)  *Intra-articular HA and Pain.*  “Based on the findings of the two prior systematic reviews, we believe that the strength of evidence is *moderate*that HA reduces pain, on average, by an amount about equivalent to the minimum clinically important difference.”  CMS Ex. 1 (pt. 1) at 226 (emphasis added).

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The assessment concluded:

Trials enrolling older participants show a small, *statistically significant effect* of HA [hyaluronic acid] on function.  Whether this effect is clinically meaningful is less clear: (sic) The research literature varies on its definition of minimum clinically important improvement.  Based on our analyses, HA demonstrated *clinically important improvements* using two out of three of these definitions for this assessment.  HA shows relatively few serious adverse events; however no studies limited participation to those 65 years or older.  No conclusions can be drawn from the available literature on delay or avoidance of TKR [total knee replacement] through the use of HA.  Studies that can compare large numbers of treated and untreated individuals, preferably with a randomized design, are needed to answer this question.

CMS Ex. 1 (pt. 1) at 126, 232 (emphasis added).  The Assessment authors noted that an issue of concern is the effectiveness and safety of HA with repeated treatment cycles.  The authors found the studies they considered were inadequate to address the concern and they concluded that studies are needed.  CMS Ex. 1 (pt. 1) at 148, 232.

*AAOS Evidence-Based Guideline (2013) and Article (2015)*

The American Academy of Orthopaedic Surgeons (AAOS) issued an “Evidence-Based Guideline 2nd Edition” for “Treatment of Osteoarthritis of the Knee,” which was adopted by the AAOS Board of Directors on May 18, 2013 (AAOS Guideline).  CMS Ex. 1 (pt. 2) at 257-873, (pt. 3) 874-1490.  The overview states that the AAOS Guideline is a “clinical practice guideline [that] is based on a systematic review of published studies examining the nonarthroplasty [nonsurgical] treatment of knee osteoarthritis in adults.”  CMS Ex. 1 (pt. 2) at 281.  The AAOS provided a summary of 15 treatment recommendations.  CMS Ex. 1 (pt. 2) at 275-280.  Applicable here, Recommendation 9 states as follows:  “We cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee.”  CMS Ex. 1 (pt. 2) at 278.  The AAOS rated the strength of this recommendation as “strong,” meaning that “the quality of the supporting evidence is high.”  CMS Ex. 1 (pt. 2) at 278.  The AAOS stated that “[p]ractitioners should follow a **Strong** recommendation unless a clear and compelling rationale for an alternative approach is present.”  CMS Ex. 1 (pt. 2) at 278.  The AAOS stated that the evidence supporting its recommendation “is based on two or more ‘High’ strength studies with consistent findings for recommending for or against the intervention.”  CMS Ex. 1 (pt. 2) at 278.  The AAOS Guideline does not address repeated injections, probably because injections are not recommended.

Page 18

The discussion states that Recommendation 9 is based on fourteen studies (three high‐strength studies and 11 moderate-strength studies) that were comparable in patient WOMAC and VAS pain scores and WOMAC function.  CMS Ex. 1 (pt. 3) at 1060.  Meta‐analysis of the meaningfully important different (MID) units “indicat[ed] a low likelihood that an appreciable number of patients achieved clinically important benefits in the outcomes.”  CMS Ex. 1 (pt. 3) at 1060.  While “meta-analyses of WOMAC pain, function, and stiffness subscales scores all found statistically significant treatment effects, none of the improvements met the minimum clinically important improvement thresholds.”  CMS Ex. 1 (pt. 3) at 1060.  Recommendation 9 discussed statistically significant improvements associated with “high-molecular cross linked hyaluronic acid,” but not with “mid-range molecular weight.”  CMS Ex. 1 (pt. 3) at 1060.  The AAOS Guidelines authors note that strict criteria are employed in using studies and trials resulting in many lower strength studies being excluded.  CMS Ex. 1 (pt. 3) at 1060-73.

The LCD Record also contains an AAOS article titled “Viscosupplementation Treatment for Knee Arthritis” which indicates it was last reviewed in June 2015 (AAOS Article).  CMS Ex. 1 (pt. 4) at 1535-37.  The article, which I infer was written for patients with OA of the knee, describes the use of hyaluronic acid injections in the knee when other nonsurgical treatment options have failed.  CMS Ex. 1 (pt. 4) at 1535.  The article states that recent research has not shown that viscosupplementation using hyaluronic acid is successful for pain relief or improvement of functioning.  However, the article states that viscosupplementation was approved by the FDA in 1997.  CMS Ex. 1 (pt. 4) at 1536.  The article states, in relevant part:

If the injections are effective they may be repeated after a period of time, usually 6 months.

* * * *

The effectiveness of viscosupplementation in treating arthritis is not clear.  It has been proposed that viscosupplementation is most effective if the arthritis is in its early stages (mild to moderate), but more research is needed to support this.  Research in viscosupplementation and its long-term effects continues.

CMS Ex. 1 (pt. 4) at 1537.

*VA/DoD Clinical Practice Guideline (2014)*

In 2014, The Osteoarthritis Working Group of the Department of Veterans Affairs (VA) and The Department of Defense (DoD) issued the VA/DoD Clinical Practice Guideline titled “Non-Surgical Management of Hip & Knee Osteoarthritis” (VA/DoD Guideline).

Page 19

CMS Ex. 1 (pt. 4) at 1521-34.  The VA/DoD Guideline states that it is “based on a systematic review of both clinical and epidemiological evidence” and was “[d]eveloped by a panel of multidisciplinary experts . . . .”  CMS Ex. 1 (pt. 4) at 1523.  In a treatment algorithm for management of hip and knee OA, the VA/DoD Guideline states that for patients with OA of the knee, “[t]here is insufficient evidence to recommend for or against the use of intra-articular hyaluronate/hyalin injection in patients with OA of the knee.”  CMS Ex. 1 (pt. 4) at 1526.  However, under “Pharmacologic Therapies,” the VA/DoD Guideline 23 qualifies this conclusion by stating that intra-articular hyaluronate/hylan injections for patients with OA of the knee “may be considered for patients who have not responded adequately to nonpharmacologic measures and who have an inadequate response, intolerable adverse events, or contraindications to other pharmacologic therapies.”  CMS Ex. 1 (pt. 4) at 1528.  The authors mark this conclusion with recommendation rating strength “I,” which reflects that “the current evidence is insufficient to assess the balance of benefits and harms” associated with the treatment.  CMS Ex. 1 (pt. 4) at 1525, 1528.

*NICE Guideline (2014)*

On February 12, 2014, the National Institute for Health and Care Excellence (NICE) issued clinical guideline titled “Osteoarthritis:  Care and Management,” which reflects patient and practitioner rights and responsibilities under the NHS (National Health Service) Constitution for England (NICE Guideline).  CMS Ex. 1 (pt. 4) at 1497.  The NICE Guideline states that current updates provide clinical guidance for decision-making and surgery, as well as new recommendations for diagnosis and follow-up, for OA, including new evidence concerning the use of hyaluronans.  CMS Ex. 1 (pt. 4) at 1496.  The NICE Guideline recommends that patients not be offered “intra-articular hyaluronan injections for the management of osteoarthritis.”  CMS Ex. 1 at 1508.

*Other Evidence in the LCD Record*

*Aetna Viscosupplementation Policy (eff. Jan. 5, 1997, last review Apr. 13, 2018) (Aetna Policy).*The Aetna Policy is that viscosupplementation for members with OA of the knee is medically necessary if certain criteria are met:  conservative therapy of at least three months has failed or is not tolerated; OA diagnosis is supported by imaging; steroid injections have failed; pain interferes with functional activities; pain cannot be attributed to other joint disease; joint replacement is not scheduled within the next six months; and there are no contraindications to injection.  CMS Ex. 1 (pt. 4) at 1538-39.  A repeat series of injections is authorized as medically necessary **within three months**of the prior series if the prior services reduce the use of pain medication and there is objective documentation of improvement in pain and functional capacity.  CMS Ex. 1 (pt. 1) at 1540.  The Aetna Policy recognizes that hyaluoronan/hyalouronate injection may

Page 20

provide symptom relief for up to six months depending upon the form.  CMS Ex. 1 (pt. 4) at 1544-45.

*Blue Cross and Blue Shield of Florida, Medical Coverage Guidelines (eff. Jun. 15, 2000, rev. Apr. 1, 2018).*The policy of Blue Cross and Blue Shield of Florida is that intraarticular hyaluronan injections are not medically necessary.  CMS E. 1 (pt. 4) at 1601.

*UnitedHealthCare® Community Plan Medical Policy (eff. Jun. 1, 2018).*  The UnitedHealthcare® policy is that intra-articular injection of hyaluronate is medically necessary for the treatment of pain secondary OA of the knee when administered according to FDA label instructions.  CMS Ex. 1 (pt. 4) at 1607.  A repeated series of injections is only authorized if more than six months have elapsed since the prior serious of injections.  CMS Ex. 1 (pt. 4) at 1608.

My review of the LCD record shows that there is not agreement among the authorities that intra-articular injection of hyaluronan is effect in reducing knee pain or limitation in function due to OA.  Furthermore, even when the use of hyaluronan is indicated, the authorities that address the issue of when repeat injections are permitted state it is only after at least six months from the prior series of injections that a repeat of injections may occur.  CMS Ex. 1 (pt. 1) at 253, 255 (Tables 4, 5) (FDA Labels for Synvisc® stating primary efficacy endpoint for pain control is six months); CMS Ex. 1 (pt. 4) at 1608 (UnitedHealthCare® Policy providing six months must elapse after prior series); and CMS Ex. 1 (pt. 4) at 1537 (AAOS Article stating usually repeat injection after six months).  The one exception is the Aetna Policy, which allows for a repeat series of injections within three months if certain conditions are met.  CMS Ex. 1 (pt. 1) at 1540).  I find that the Aetna Policy, which does not explain the three-month policy, does not make the LCD provisions at issue before me unreasonable considering all the evidence in the LCD Record.

When conducting an LCD review, I do not review whether an item or service is reasonable and necessary for an individual Medicare beneficiary.  Rather, I am limited to reviewing an LCD for whether or not it meets the reasonableness standard.  Act § 1869(f)(2)(A); 42 C.F.R. §§ 426.325(b)(4), (5), (11), (12), 426.405(d)(5).

The regulation provides that after receiving:  (1) the LCD record; (2) the AP’s statement of why the LCD is not valid, including evidence submitted in support of that position; and (3) the contractor’s response to the AP’s statement, I am to apply the reasonableness standard to determine whether the LCD record is complete and adequate to support the validity of the LCD.  42 C.F.R. § 426.425(c)(1).  During an LCD review, the aggrieved party bears the burden of proof and the burden of persuasion for the issues raised in the complaint.  42 C.F.R. § 426.330.

Page 21

Under the reasonableness standard as defined by 42 C.F.R. § 426.110, I must uphold the challenged LCD provisions “if the findings of fact, interpretations of law, and applications of fact to law by the contractor or CMS are reasonable based on the LCD” record and any record developed before me.  42 C.F.R. § 426.110.  If the challenged LCD “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 challenged provisions must be upheld as reasonable.  68 Fed. Reg. at 63,703.  Consideration of the quantity of the evidence submitted and an evaluation of the persuasiveness of the material is appropriate.  The reasonableness standard cannot be met if the challenged LCD provision “is in direct conflict with the plain language of the statute or regulation being interpreted,” or with an NCD, or 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. at 63,703-04*.*In deciding the issue of whether or not the LCD record is complete and adequate to support the validity of the challenged LCD provision, I am required to consider the contractors’ findings of fact, interpretations of law, and application of the facts to law when applying the reasonableness standard.  42 C.F.R. § 426.450(b)(4).

The Aggrieved Party challenges the provisions of LCD L35427 that limit intra-articular injections of hyaluronic acid into the knee for OA to no more often than every six months.  The Novitas determination that intra-articular injections of hyaluronic acid, including Synvisc® One injections, are reasonable and necessary no more often than once every six months if required conditions are met, is consistent with the FDA indications and limitations, the 2015 AAOS Article, and the United HealthCare® policy.  Only the Aetna Policy specifically permits a repeat series within three months and the rationale for that policy is not stated.  CMS Ex. 1 (pt. 4) at 1540.  Novitas’s findings of fact, interpretations of law, and application of the facts to law that are the basis for challenged LCD provisions are reasonable based on the LCD record.  42 C.F.R. § 426.100.  I conclude that the LCD record is complete and adequate to support the validity of the LCD at issue in this case.  The challenged LCD provisions, which I conclude are not in conflict with the Act, regulations, NCDs, or CMS Rulings, must be upheld.  The Aggrieved Party’s challenge to the LCD provisions must fail.

**Issuance of this decision finding the LCD record complete and adequate to support the validity of the challenged LCD provisions ends the review process. 42 C.F.R. § 426.425(c)(2).**The LCD record is complete and adequate to support the validity of the challenged LCD provisions 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).

Page 22

III.  Conclusion

The LCD record is complete and adequate to support the validity of the LCD provisions at issue under the reasonableness standard.  Therefore, review of the challenged LCD is complete.

IV.  Appeal Rights

The Aggrieved Party is notified pursuant to 42 C.F.R. §§ 426.450 and 426.465 of his right to appeal this Decision to the Board for review.  Unless there is good cause shown, an appeal must be filed within 30 days of the date of this decision.  42 C.F.R. § 426.465(e).  An appeal must include the full names and addresses of the parties, including the name of the LCD at issue, the date this decision was issued, the docket number for this case (C-19-1132), a statement identifying the parts of this decision that are being appealed, and a statement explaining why this decision should be reversed.  42 C.F.R. § 426.465(f)(1)-(3).  The Aggrieved Party may appeal to the Board any part of this decision that states a provision of an LCD is valid under the reasonableness standard.  42 C.F.R. § 426.465(a)(1).


          /s/
        Keith W. Sickendick

                      Administrative Law Judge
      1. There are other conditions and limitations related to repeat hyaluronan knee injections, but those requirements are not challenged before me.  Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 6-8. back to note 1
                      2. LCD L35427 explains that a series of hyaluronan injections, initial or repeat, may be a single intra-articular (within the knee joint) injection or a set of two to five weekly intra-articular injections per knee, depending on the hyaluronan preparation used based on Food and Drug Administration (FDA) package instructions.  CMS Ex. 1 at 7, 14.  Hyaluronan is also referred to in documents in the LCD record as sodium hyaluronate and hyaluronic acid.  Eg., CMS Ex. 1 (pt. 4) at 1610.  There are several different manufacturers with different proprietary names.  Eg., CMS Ex. 1 (pt. 4) at 1607-08. back to note 2
                      3. The names of Medicare beneficiaries are not listed in published decisions to protect their privacy.  68 Fed. Reg. 63,692, 63,709 (Nov. 7, 2003). back to note 3
                      4. Citations to the Complaint in this decision are to the document originally filed by the Aggrieved Party by mail and uploaded to the Departmental Appeals Board Electronic Filing System (DAB E-File) as Item #1 and the amended Complaint filed in this case under DAB E-File ##4-16.  Due to inconsistencies in the marking of documents by the Aggrieved Party, citations to DAB E-File # are for the convenience of the Departmental Appeals Board (Board) in the event of a subsequent appeal. back to note 4
                      5. On January 16, 2020, I issued an order severing the dismissal of the Complaint as to LCD L33318, to permit the Board to proceed with review of an appeal of the dismissal order filed with the Board by the Aggrieved Party on January 10, 2020.  The Board affirmed the dismissal of the complaint as to LCD L33318 on June 25, 2020.  LCD Complaint:  Knee Orthoses (LCD L33318), DAB No. 3005 (2020). back to note 5
                      6. In evaluating whether the Complaint was acceptable, I noted that the Aggrieved Party did submit a letter from his physician, dated July 30, 2019, stating why the Aggrieved Party needed four hyaluronic acid injections in one year (one every three months), rather than the two injections per year (one every six months) allowed under LCD L35427.  The physician’s letter is dated within 120 days of the filing of the Complaint.  Pursuant to 42 C.F.R. § 426.400(b)(1), an LCD complaint is considered timely when it is filed within six months of issuance of a written statement from a treating practitioner if a challenge to the LCD is filed before receiving the service.
The Complaint does not indicate that the Aggrieved Party elected to receive more than two hyaluronan acid injections in one year for which a Medicare-claim was filed.  Email correspondence between the Aggrieved Party and his physician office, dated July 3, 2019, requests that the Aggrieved Party sign an Advance Beneficiary Notice (ABN) “to submit for the early Synvisc One® [a form of hyaluronic acid] injections.”  P. Ex. 2 at 1; DAB E-File #7.  The effect of an ABN is to make the Medicare beneficiary responsible for the cost of services for which Medicare coverage is denied rather than the supplier.  The record is silent on whether the Aggrieved Party signed an ABN.  However, on March 30, 2021, the Aggrieved Party filed a March 8, 2021 notice of a redetermination from the MAC indicating that his claim for intra-articular injection, which was initially denied February 5, 2021, was again denied on redetermination pursuant to LCD L35427, because six months had not elapsed following prior injection on August 7, 2020.  I note that the notice advised the Aggrieved Party he had the right to appeal the redetermination but did not specify where the appeal should be sent.  DAB E-File #35. back to note 6
                      7. Noridian filed CMS Ex. 1 in four parts marked with pages numbered 1 through 1659.  DAB E‐File ##20-23.  The Exhibit List organizes the documents as follows:  LCD Under Challenge pp. 1-48; Journal Articles Considered under LCD pp.  49-120; Technology Assessments pp. 121-243; Documentation from the FDA pp. 244-256; Clinical Guidelines pp. 257-1534; Other Documents Considered in LCD Policy Development pp. 1535-1625; and Contractor’s Statement and Response Document pp. 1626‐1659.  The four parts of CMS Ex. 1 consist of the following pages:  Part 1 pp. 1‐256; Part 2 pp. 257-873; Part 3 pp. 874-1490; and Part 4 pp. 1491-1659. back to note 7
                      8. CMS manuals can be found online at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs. back to note 8
                      9. Benefit appeals under Medicare Parts A, B, and C were previously adjudicated by ALJs assigned to the Social Security Administration (SSA).  The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, § 931(a) and (b) (2003), required that the Secretary and the Commissioner of Social Security transfer the responsibility for adjudicating such appeals from SSA to the Department of Health and Human Services.  OMHA was created as a result.  70 Fed. Reg. 36,386 (June 23, 2005) (Office of Medicare Hearings and Appeals; Statement of Organization, Functions, and Delegations of Authority). back to note 9
                      10. Provisions for the review of NCDs and LCDs were added to section 1869 of the Act by the Benefits Improvement and Protection Act of 2000, Pub. L. No. 106-554, § 522 (2000). back to note 10
                      11. The aggrieved party must file copies of clinical or scientific evidence in support of his or her complaint that an LCD is not reasonable.  42 C.F.R. §§ 426.400(c)(6), 426.403. back to note 11
                      12. I have shortened the statement of the issue to “whether the LCD satisfies the reasonableness standard” throughout the decision for easier reading only. back to note 12
                      13. LCD L35427 is in evidence marked as CMS Ex. 1 at 1-29.  CMS’s Medicare Coverage Database indicates that Novitas has not retired or made any revisions to LCD L35427 since filing the record in this case.  42 C.F.R. § 426.420.  The current LCD and prior revisions are publicly available at https://www.cms.gov/medicare-coverage-database/new-search/search.aspx (last visited Dec. 6, 2021). back to note 13
                      14. Novitas has also issued a Local Coverage Article (A55036) that provides coding guidelines for intra-articular knee injections of hyaluronans and defines “series [as] a set of injections for each joint and each treatment.”  CMS Ex. 1 (pt. 1) at 37.  The Local Coverage Article is not subject to my review under 42 C.F.R. pt. 426.  42 C.F.R. § 426.325(a). back to note 14
                      15. The assessment makes clear that its findings and conclusions are those of the authors and “no statement in this report should be construed as an official position of” AHRQ or HHS.  CMS Ex. 1 (pt. 1) at 122-23. back to note 15
                      16. “WOMAC” is the abbreviation for Western Ontario and McMaster Universities Osteoarthritis Index, while “VAS” is the abbreviation for Visual Analogue Scale (Score).  CMS Ex. 1 (pt. 1) at 131, 164. back to note 16 Back to top
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