Medicare coverage policies are supposed to be based on: 1) peer-reviewed literature; 2) the consensus of experts; and 3) whether a technology has been accepted by the relevant medical community. In the absence of a National Coverage Determination, Medicare contractors are free to develop a Local Coverage Determination policy. There are seven different Medicare contractor jurisdictions and, most often, the policies (known as LCDs) in each of them align. However, there have been some striking examples where one contractor has declined to cover a technology although the other contractors were covering it. See e.g., PTNS. An LCD challenge can prompt a contractor to re-align a non-coverage policy with the rest of the country, but the LCD challenge process takes time and resources.
Many men who are diagnosed with prostate cancer receive prostate radiation. Unfortunately, because the prostate and the rectum are so close together, the rectum often receives unintended radiation. If the rectum is subject to radiation, that can cause significant side effects (e.g., rectal leakage). If only there were more space between the prostate and the rectum, the risk of unintentionally irradiating the rectum when trying to treat the prostate could be minimized or avoided. That is what a perirectal spacer is for.
A perirectal spacer literally creates space between the prostate and the rectum. A perirectal spacer is made of a hydrogel (a kind of firm jelly) that can be inserted between the rectum and the prostate to prevent such damage. It is placed once and dissolves after the course of radiation. All but one of the Medicare contractors cover perirectal spacers. The one contractor denies claims on the basis that the spacer is experimental and investigational although: 1) numerous peer-reviewed studies show it is safe and effective; 2) the relevant professional societies (ASTRO, ACR and ABS) support coverage and it is included in the NCCN guidelines; and 3) the perirectal spacer is widely used throughout the country.
Medicare beneficiaries can appeal claims they believe should be covered by Medicare, notwithstanding a negative local coverage determination. Local coverage determinations are not binding on Medicare’s administrative law judges, but they must give substantive deference to the local policy or explain why they are not applying it. The majority of Medicare’s administrative law judges who have considered whether Medicare should pay for a spacer have declined to follow the one Medicare contractor’s policy and the arguments that the Medicare contractor has made during the hearings. In rejecting the arguments, one judge ruled:
[T]he ALJ . . . does not need to give substantial deference to the LCD because the FDA approved perirectal spacer gel’s clinical efficacy is documented in the medical literature with more than enough support in the peer-reviewed literature and has achieved sufficient adoption by the medical community to receive a category I CPT code. Additionally, many MACs cover [the SpaceOAR procedure]. NGS, in its position paper, argues [SpaceOAR] is not covered by Medicare because it is a preventative service in that it is not being furnished for the diagnosis or treatment of the beneficiary’s condition and is only being used to prevent rectal toxicity from the radiation therapy. [citation omitted] This argument is disingenuous. The perirectal spacer is implanted to reduce rectal pain and rectal toxicity during the radiation therapy as well as long term rectal toxicity. [citation omitted]. The perirectal spacer, then, is part of the beneficiary’s treatment. To say that it is preventative would be tantamount to stating pain medications or anesthesia would not be covered because they are preventative (i.e., given to prevent pain). . . The QIC with jurisdiction over NGS’ redetermination has also overturned denials of the [SpaceOAR] . . . It would be patently unfair for Medicare not to cover Appellant’s procedure while it has covered the same procedure for other beneficiaries in the same jurisdiction on the same date of service. ALJ Case No. 1-6953238299, February 2, 2018.
[T]his ALJ finds that it is appropriate to deviate from the applicable LCD as the research articles, the peer-reviewed journals, the testimony of the treating physician, and medical documentation in the record shows conclusively that the procedure was not investigational and was medically accepted as the standard of care on July 18, 2017. ALJ Case No. 1-7245728836, April 11, 2018.
The transition from a Category III to a Category I signals the acceptance of the greater medical community that this procedure is no longer experimental, and that it is safe, effective, and medically reasonable and necessary. Moreover, the QIC in this case has approved payment for this procedure more than 25 times in the past two years, covering dates of service at least as far back as June 2016….The ALJ takes these factors into consideration to determine that the use of perirectal hydrogel spacers is widely accepted by the medical community (and by Medicare Contractors, for that matter) as a safe and effective procedure to prevent rectal toxicity during radiation therapy. ALJ Case No. 1-7501404546, July 5, 2018.
The overwhelming weight of peer-reviewed medical evidence supports the effectiveness of the spacer in reducing complications from prostate cancer radiation treatment. ALJ Case No. 1-7521574673, June 20, 2018.
To protect themselves against financial loss in the face of a negative local coverage policy, some clinicians require their patients to pay for the spacer up front (more than $3,000) and advise the patient that they can appeal an anticipated denial through the Medicare appeals process. Although more than 80% of the appealed cases have resulted in judges ordering the Medicare contractor to cover the spacer and pay, the process is a long one. For a partial list of cases where the ALJ ordered the Medicare contractor to make payment, click here. Favorable ALJ Decisions for Spacer
Although a policy challenge might compel the Medicare contractor to change its policies, one would hope that a Medicare contractor would reconsider its policy after reviewing so many judicial decisions finding its policy and justifications for denying coverage to be flawed. In the interim, more Medicare beneficiaries will continue to appeal denied claims and add to the already backlogged Medicare system. Parrish Law Offices has represented numerous Medicare beneficiaries seeking coverage of denied spacer claims. Please contact us if you have any questions regarding the above.