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By Nicole Graci of Hamberger & Weiss LLP (NY) and Daniel Hayes of Teague Campbell Dennis & Gorham LLP (NC)
The NWCDN has re-established its Medicare Compliance Committee, and what great timing! On January 10, 2022, the Centers for Medicare and Medicaid Services (CMS) updated the Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide, which it does periodically, but this update sent shockwaves throughout the Medicare compliance community. As our first act as a committee, we offer the following analysis of what has become known as “The 4.3 Update.”
CMS’ 1/11/22 update to Section 4.3 of the WCMSA Reference Guide is a strong message about CMS’ view of evidence based or non-submit WCMSA products. On March 15, 2022, CMS updated the Reference Guide again, to clarify that message.
CMS expressed its concern that products commonly called “evidence-based” or “non-submit” MSAs are not adequately protecting Medicare’s interests. Here is the full text of the 1/10/22 update,
4.3 The Use of Non-CMS-Approved Products to Address Future Medical Care
A number of industry products exist with the intent of indemnifying insurance carriers and CMS beneficiaries against future recovery for conditional payments made by CMS for settled injuries. Although not inclusive of all products covered under this section, these products are most commonly termed “evidence-based” or “non-submit.” 42 C.F.R. 411.46 specifically allows CMS to deny payment for treatment of work-related conditions if a settlement does not adequately protect the Medicare program’s interest. Unless a proposed amount is submitted, reviewed, and approved using the process described in this reference guide prior to settlement, CMS cannot be certain that the Medicare program’s interests are adequately protected. As such, CMS treats the use of non-CMS-approved products as a potential attempt to shift financial burden by improperly giving reasonable recognition to both medical expenses and income replacement. As a matter of policy and practice, CMS will deny payment for medical services related to the WC injuries or illness requiring attestation of appropriate exhaustion equal to the total settlement less procurement costs before CMS will resume primary payment obligation for settled injuries or illnesses. This will result in the claimant needing to demonstrate complete exhaustion of the net settlement amount, rather than a CMS-approved WCMSA amount.
There has been an increase in the use of evidence based or non-submit WCMSA products in the last few years. Under the theory that CMS’ method for calculating a WCMSA results in inflated medical and prescription expense, resulting in higher settlement costs, evidence based or non-submit MSAs are calculated using alternative methods, resulting in reduced treatment and medication over a claimant’s lifetime and less expense. These products are often accompanied by “guarantees,” offers of post-settlement professional administration of MSA funds, structured WCMSAs and, in some cases, reversionary interests. In response to the 1/11/22 update, the purveyors of evidence based or non-submit MSA products immediately published analyses, arguing that CMS was contradicting the well-established legal reality that CMS pre-settlement approval of a WCMSA is voluntary. Detailed arguments were presented, outlining how CMS was overreaching its authority. CMS responded with the subsequent update on March 15, 2022.
However, a close reading of the January and March updates and review of the Medicare Secondary Payer statute and accompanying federal regulations reveals that the updates are consistent with CMS’ long standing policy that CMS pre-settlement approval, although not required by law, has been and continues to be recommended. The March 15, 2022 update softened the language of the January update, notably changing “will deny” to “may at its sole discretion deny” in reference to post-settlement payment of Medicare covered, causally related services. In addition, the beneficiary/claimant’s burden to attest to proper expenditure of the MSA funds is clarified to include a showing that, “both the initial funding of the MSA was sufficient, and utilization of MSA funds was appropriate.” CMS also clarified that its policy applies to notifications of settlements using evidence based or non-submit MSAs from 1/11/22 forward, but that it is flagging pre-1/11/22 notifications as well. CMS went on to reiterate the legal requirement of the Medicare Secondary Payer statute, regulations, and CMS memorandum that primary payers are obligated to consider Medicare’s interests at settlement, while recognizing that all settlements do not meet the CMS work review thresholds for pre-settlement approval of a WCMSA. It is well known that the CMS work review thresholds are internal and are not safe harbors.
The full text of the March 15, 2022 update is below, with changes highlighted,
4.3 The Use of Non-CMS-Approved Products to Address Future Medical Care
A number of industry products exist for the purpose of complying with the Medicare Secondary Payer regulations without participation in the voluntary WCMSA review process set forth in this reference guide. Although not inclusive of all products covered under this section, these products are most commonly termed “evidence-based” or “non-submit.” 42 C.F.R. 411.46 specifically allows CMS to deny payment for treatment of work-related conditions if a settlement does not adequately protect the Medicare program’s interest. Unless a proposed amount is submitted, reviewed, and approved using the process described in this reference guide prior to settlement, CMS cannot be certain that the Medicare program’s interests are adequately protected. As such, CMS treats the use of non-CMS-approved products as a potential attempt to shift financial burden by improperly giving reasonable recognition to both medical expenses and income replacement. As a matter of policy and practice, CMS may at its sole discretion deny payment for medical services related to the WC injuries or illness, requiring attestation of appropriate exhaustion equal to the total settlement as defined in Section 10.5.3 of this reference guide, less procurement costs and paid conditional payments, before CMS will resume primary payment obligation for settled injuries or illnesses, unless it is shown, at the time of exhaustion of the MSA funds, that both the initial funding of the MSA was sufficient, and utilization of MSA funds was appropriate. This will result in the claimant needing to demonstrate complete exhaustion of the net settlement amount, rather than a CMS-approved WCMSA amount. Notes: This official policy shall apply to all notifications of settlement that include the use of a non-CMS-approved product received on, or after, January 11, 2022; however, flags in the Common Working File for notifications received prior to that date will be set to ensure Medicare does not make payment during the spend-down period. CMS does not intend for this policy to affect any settlement that would not otherwise meet review thresholds. This comment does not relieve the settling parties of an obligation to consider Medicare’s interests as part of the settlement; however, CMS does not expect notification or submission where thresholds are not met.
CMS did not change its prior WCMSA Reference Guide language, making it clear that the submission process is completely voluntary, as follows:
There are no statutory or regulatory provisions requiring that you submit a WCMSA amount proposal to CMS for review. If you choose to use CMS’ WCMSA review process, the Agency requests that you comply with CMS’ established policies and procedures.
WCMSA Reference Guide., pp. 1, 9 (emphasis original). Of note, this italicized language is found twice in the Reference Guide.
The Medicare Secondary Payer statute and accompanying regulations have always afforded CMS the authority to deny payment for work-related treatment if a settlement does not adequately protect Medicare’s interests. See 42 C.F.R. 411.46, emphasis added:
§ 411.46 Lump-sum payments.
(a) Lump-sum commutation of future benefits. If a lump-sum compensation award stipulates that the amount paid is intended to compensate the individual for all future medical expenses required because of the work-related injury or disease, Medicare payments for such services are excluded until medical expenses related to the injury or disease equal the amount of the lump-sum payment.
(b) Lump-sum compromise settlement.
(1) A lump-sum compromise settlement is deemed to be a workers' compensation payment for Medicare purposes, even if the settlement agreement stipulates that there is no liability under the workers' compensation law or plan.
(2) If a settlement appears to represent an attempt to shift to Medicare the responsibility for payment of medical expenses for the treatment of a work-related condition, the settlement will not be recognized. For example, if the parties to a settlement attempt to maximize the amount of disability benefits paid under workers' compensation by releasing the workers' compensation carrier from liability for medical expenses for a particular condition even though the facts show that the condition is work-related, Medicare will not pay for treatment of that condition.
(c) Lump-sum compromise settlement: Effect on services furnished before the date of settlement. Medicare pays for medical expenses incurred before the lump-sum compromise settlement only to the extent specified in § 411.47.
(d) Lump-sum compromise settlement: Effect on payment for services furnished after the date of settlement -
(1) Basic rule. Except as specified in paragraph (d)(2) of this section, if a lump-sum compromise settlement forecloses the possibility of future payment of workers' compensation benefits, medical expenses incurred after the date of the settlement are payable under Medicare.
(2) Exception. If the settlement agreement allocates certain amounts for specific future medical services, Medicare does not pay for those services until medical expenses related to the injury or disease equal the amount of the lump-sum settlement allocated to future medical expenses.
Essentially, the January and March 2022 updates did not change anything regarding a primary payer’s obligation to protect the Medicare fund by considering Medicare’s future interests at time of settlement. Similarly, the updates did not change the CMS work review thresholds for pre-settlement approval of a WCMSA. Most importantly, the updates did not change the well-established tenet that CMS pre-settlement approval of a WCMSA is voluntary. Rather, the updates simply made clear CMS’ position that evidence based or non-submit MSAs will be scrutinized for consistency with the methodology that CMS uses to evaluate WCMSAs that are voluntarily submitted. This should not come as a surprise, as CMS put considerable resources behind developing a methodology for WCMSA review, engaging review contractors, and promulgating its methods through memorandum, town hall teleconferences, webinars, a robust website, and the WCMSA Reference G.
Certainly, finding a primary payer that never disagreed with a CMS counter-higher WCMSA proposal would be akin to finding a unicorn. All primary payers can cite examples of CMS approved WCMSAs that include outlandish prescription medications, surgeries that will never take place and treatments extending a lifetime for claimants who will cease treatment shortly following settlement. An evidence based/non-submit MSA is a permissible way for a primary payer to address those concerns, but not the only way. Depending on risk tolerance of the parties, CMS submission may still be preferred. Careful preparation of a WCMSA for submission to CMS, especially one prepared by counsel, includes implementation of legal strategies based on state specific workers’ compensation laws and treatment guidelines, and use of contrary medical evidence and/or litigation to effectively reduce prescriptions or treatment BEFORE submission to CMS. The resulting, palatable, CMS approved MSA effectuates settlement, as both the primary payer and the Medicare beneficiary/claimant can be secure in the knowledge that CMS has blessed their schism, evidenced by a CMS pre-settlement approval letter.
Practice Tip: As always, parties should adequately consider Medicare’s interests, whether or not the settlement will qualify for voluntary submission to CMS for formal review. The decision to participate in the voluntary submission process or use an evidence based or non-submit MSA should be made in consultation with counsel or other vendors who are well versed in Medicare compliance matters, and with full cooperation of the parties, on a case-by-case basis.
Stay tuned for more activity by your Medicare Compliance Committee - paperless conditional payments, forthcoming Section 111 reporting penalties, Medicare Advantage Plan Liens and more coming your way! Meet the members live in Nashville at the NWCDN national conference, where we will be presenting a Medicare Compliance update. Please contact Nicole Graci of Hamberger & Weiss LLP (NY) or Daniel Hayes of Teague Campbell Dennis & Gorham, LLP (NC) for more information.