LCD Complaint: Pressure Reducing Support Surfaces – Group 2 (L33642), DAB CR6340 (2023)

DECISION DISMISSING LCD COMPLAINT

A local coverage determination (LCD) complaint dated July 6, 2023, and postmarked July 7, 2023, was filed on behalf of a Medicare beneficiary – the Aggrieved Party.¹  The complaint challenged LCD L33642 titled Pressure Reducing Support Surfaces – Group 2.  The complaint must be dismissed because it is unacceptable under 42 C.F.R. § 426.410(c)(2).  The Aggrieved Party is entitled to request further review by the Appellate Division of the Departmental Appeals Board (the Board) as explained hereafter.

I.    Background

The LCD complaint (Compl.) was filed on July 7, 2023, by JR under authority of a Power of Attorney executed by the Aggrieved Party.

According to JR, the Aggrieved Party needs a low air loss mattress, also referred to as a powered pressure-reducing air mattress, to avoid the development of pressure ulcers.  Evidence filed with the complaint shows that:

On May 15, 2023, a low air loss mattress was purchased from a durable medical equipment supplier for $750.  Compl. at 9-12 (document page counter).

On June 5, 2023, a physician’s assistant (PA) signed a letter that explained that the Aggrieved Party needed a low air loss mattress because, as of May 15, 2023, she had an open pressure ulcer on her right heel and on the outside of her upper left

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thigh.  The PA opined that the ulcers were due to the Aggrieved Party using a regular mattress and her inability to change positions without assistance while in bed.  The PA’s visit notes and order for a low air loss mattress based on a diagnosis of pressure ulcers were also submitted with the complaint.  Compl. at 4-6.

By letter dated June 8, 2023, CGS, which was the durable medical equipment Medicare administrative contractor (DME MAC) at the time,² denied a request for prior authorization (a determination in advance of the purchase of durable medical equipment (DME) that Medicare would pay for the DME).  There is no indication when the prior authorization request was submitted to and received by the DME MAC.  The DME MAC stated that the Aggrieved Party did not meet the medical necessity requirements for an “E0277 Powered pressure-reducing air mattress” because the medical record did not show any pressure ulcers on the Aggrieved Party’s trunk or pelvis.  The DME MAC cited LCD L33642 and Policy Article A52490 as the basis for denial of a prior authorization.  The DME MAC explained that the prior authorization request could be resubmitted with additional medical documentation that might affect the denial decision.  The DME MAC also explained that if the DME supplier submitted a claim without obtaining prior authorization, the claim would be denied, but either the supplier or beneficiary could appeal the claim denial.  Compl. at 3.  The DME MAC letter submitted with the complaint is only one page without a signature block, indicating the complete letter may not have been filed.  The single page filed with the complaint does not reflect that the DME MAC explained how an appeal of either the prior authorization denial or a future claim denial should be filed.

No evidence has been filed that shows that the DME supplier or JR resubmitted the prior authorization request.

No evidence has been filed that shows that the DME supplier or JR filed a claim with the DME MAC after the low air loss mattress was purchased from the DME supplier.

I advised JR on behalf of the Aggrieved Party by letter dated July 24, 2023, that I had reviewed the complaint and found it unacceptable.  I advised JR that he must submit evidence of his authority to act for the Aggrieved Party.  JR corrected this defect on

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August 1, 2023, by filing a document granting him power of attorney to act on behalf of the Aggrieved Party.

I also advised the Aggrieved Party in my July 24, 2023 letter that the complaint was unacceptable because no clinical or scientific evidence was submitted to show that the LCD provision relied upon by the DME MAC to deny coverage for a low air loss mattress was unreasonable.  The Aggrieved Party filed an amended complaint (Amended Compl.) on August 10, 2023.  I conclude that the amended complaint is unacceptable and that it must be dismissed.

II.    Discussion

A.    Applicable Law

Section 1862 of the Social Security Act (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 “which . . . are not reasonable and necessary for the diagnosis or treatment of illnesses or injury or to improve the function of a malformed body member. . . .”  The Secretary of the Department of Health and Human Services (the 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, 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.

The Centers for Medicare and Medicaid Services (CMS) administers the Medicare program (Act §§ 1102, 1871, 1874) and contracts with carriers and intermediaries (Medicare administrative contractors) to act on its behalf in determining and making payments to providers and suppliers of Medicare items and services.  Act §§ 1816, 1842.  The Act provides for both National Coverage Determinations (NCD) and LCDs.  Act § 1869(f)(1)(B) and (2)(B) (42 U.S.C. § 1395ff(f)(1)(B) and (2)(B)).  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)); 42 C.F.R. § 400.202.  In the absence of an NCD or an LCD, individual claims determinations are made based upon an individual beneficiary’s particular factual situation.  68 Fed. Reg. 63, 691, 63,693 (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).

An aggrieved Medicare beneficiary who has been denied coverage for an item or service based on an LCD may challenge that LCD before an administrative law judge (ALJ).

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The aggrieved party initiates the review by filing a written c that meets the criteria specified in the governing regulations.  42 C.F.R. §§ 426.400; 426.410(b)(2).  If an ALJ determines that the complaint is unacceptable, the ALJ must provide the aggrieved party one opportunity to amend the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  If the aggrieved party fails to submit an acceptable amended complaint within a reasonable timeframe as determined by the ALJ, the ALJ must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  If a complaint is determined unacceptable after one amendment, the beneficiary is precluded from filing again for six months after being informed that it is unacceptable.  42 C.F.R. § 426.410(c)(3).

B.    Findings of Fact, Conclusions of Law, and Analysis

1.    The Aggrieved Party’s Amended Complaint is unacceptable, and it must be dismissed under 42 C.F.R. § 426.410(c)(2) for failure to comply with the requirement of 42 C.F.R. § 426.400(c)(6).

2.     The Aggrieved Party is precluded from filing again for six months from the date of this decision.  42 C.F.R. § 426.410(c)(3).

I advised the Aggrieved Party in my July 24, 2023 letter that the LCD complaint was unacceptable because no clinical or scientific evidence was submitted to show that the LCD provision relied upon by the DME MAC to deny coverage for a low air loss mattress was unreasonable.  I advised the Aggrieved Party that the clinical or scientific evidence needed to be evidence other than the Aggrieved Party’s treating physician’s orders and notes.  A treating physician’s written statement, which could be an order or other documentation from the Aggrieved Party’s medical records, that shows a Medicare beneficiary needs a service must be submitted with a complaint.  42 C.F.R. § 426.400(c)(3).  However, clinical or scientific evidence that the Aggrieved Party believes shows that the LCD provision relied on to deny services is unreasonable, must also be submitted as part of an acceptable complaint.  42 C.F.R. § 426.400(c)(6).

JR explains in the Aggrieved Party’s August 10, 2023 amended complaint that the Aggrieved Party, who is in the final stages of Alzheimer’s disease, started receiving hospice care on August 9, 2022, and, at that time, she had a pressure ulcer on her right heel.  Hospice provided the Aggrieved Party a low air loss mattress and the heel ulcer resolved.   Hospice care was stopped on April 5, 2023, and hospice removed the Aggrieved Party’s hospice-provided hospital bed and low air loss mattress.  The Aggrieved Party’s physician ordered a new hospital bed that came with a standard mattress.  In less than a month of using the standard mattress, the Aggrieved Party developed a pressure ulcer on her upper left thigh.  JR discussed this with the Aggrieved Party’s treating physician who ordered a low air loss mattress, which JR then purchased from the DME supplier with delivery on May 16, 2023.  According to JR, during the

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three months following switching to using the low air loss mattress, the Aggrieved Party’s hip ulcer resolved, and she had no new ulcers.  Petitioner argues this is compelling clinical evidence that the Aggrieved Party needed the low air loss mattress.  Amended Compl.  I construe JR’s argument to be that the healing of the hip ulcer and prevention of new ulcers shows that the Aggrieved Party’s use of a low air loss mattress was reasonable and necessary.  JR also argues that LCD L33642 is unreasonable because it requires that a beneficiary have an ulcer on the trunk or pelvis for at least a month that fails to improve with other treatment.  JR argues that in the Aggrieved Party’s case ulcers developed rapidly in much less than a month and it is not reasonable to expect staff in the facility where the Aggrieved Party resides to regularly turn the Aggrieved Party as required by the LCD.

The original LCD L33642 issued by the DME MACs was effective on October 1, 2015.³  It was revised on May 1, 2021.  The LCD provides, among other things, that a claim for a low air loss mattress will be denied as not being reasonable and necessary unless certain coverage criteria are satisfied.  The coverage criteria pertinent to this case are:  (1) the Medicare beneficiary must have multiple small stage 2 pressure ulcers on the trunk or pelvis which have not improved over the past month despite a comprehensive ulcer treatment program with specific interventions, or (2) the beneficiary has large or multiple stage 3 or 4 pressure ulcers on the trunk or pelvis.  The DME MAC’s June 8, 2023, letter denying prior authorization, states that the DME MAC denied coverage in the Aggrieved Party’s case because she had no pressure ulcers on her trunk or pelvis.  Compl. At 3.

I do not review whether the DME MAC incorrectly denied the Aggrieved Party coverage for a low air loss mattress.  42 C.F.R. § 426.310.  Individual claim review is available to the Aggrieved Party through the claim appeals process.⁴   What I must decide is whether the challenged LCD provisions meet the reasonableness standard.  42 C.F.R. §§ 426.425(c), 426.431.

JR’s arguments that there is clinical evidence that the Aggrieved Party benefitted from a low air loss mattress may be evidence that could be considered in an individual claim review to determine whether such a mattress was reasonable and necessary for the Aggrieved Party despite the LCD that caused a different result.  However, JR’s

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arguments are not the type of clinical and scientific evidence required for an acceptable LCD complaint.  The clinical and scientific evidence required for an acceptable complaint is evidence the Aggrieved Party thinks shows that the LCD is unreasonable.  42 C.F.R. § 426.400(c)(6).  In this case the evidence must tend to show that it is unreasonable for the DME MAC to adopt an LCD that establishes a general rule that a low air loss mattress is not reasonable and necessary and not covered by Medicare absent medical evidence that a Medicare beneficiary has multiple stage 2 pressure ulcers on the trunk or pelvis that have not healed in 30 days despite treatment, or a large or multiple stage 3 or 4 pressure ulcers on the pelvis or trunk.  The Aggrieved Party has presented no such evidence despite an opportunity to amend the LCD complaint.  Therefore, the LCD complaint must be dismissed.

3.     Appeal rights.  42 C.F.R. §§ 426.462, 426.465.

Pursuant to 42 C.F.R. § 426.465(a), an aggrieved party may request review by the Board.  Except upon a showing of good cause, a request for review by the Board must be filed within 30 days of the date of this decision (42 C.F.R. § 426.465(e)) and must comply with the requirements of 42 C.F.R. § 426.465(f).

III.  Conclusion

For the foregoing reasons, the LCD complaint is dismissed.

Endnotes

¹  The names of Medicare beneficiaries are not listed in published decisions to protect their privacy.  68 Fed. Reg. 63,691, 63,709 (Nov. 7, 2003).

²  The current DME MAC is Maximus.  The Maximus appeals portal may be accessed at https://www.medicareappeal.com/.  Maximus explains the DME appeals process at https://www.medicareappeal.com/medicare-durable-medical-equipment-dme-appeals.

³  Available at https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33642&ver=26&bc=0.

⁴  The claim appeals process is administered through the DME MAC (Maximus) (more information is available at the links listed in footnote 2), followed by ALJ review by ALJs with the Office of Medicare Hearings and Appeals (OMHA).  Information for OMHA hearings is found at https://www.hhs.gov/about/agencies/omha/filing-an-appeal/coverage-and-claims-appeals/index.html.