This past week the Office of Management and Budget posted two rulemaking notices from the Centers for Medicare and Medicaid Services (CMS), one with implications for the consideration of future medicals in liability settlements and the other regarding criteria for imposing penalties under the Medicare Secondary Payer Act related to the Section 111 Mandatory Insurer Reporting requirements.

Liability and Future Medicals

The first notice titled Miscellaneous Medicare Secondary Payer Clarifications and Updates (CMS-6047-P), states as follows:

This proposed rule would ensure that beneficiaries are making the best health care choices possible by providing them and their representatives with the opportunity to select an option for meeting future medical obligations that fits their individual circumstances, while also protecting the Medicare Trust Fund. Currently, Medicare does not provide its beneficiaries with guidance to help them make choices regarding their future medical care expenses when they receive automobile and liability insurance (including self-insurance), no fault insurance, and workers’ compensation settlements, judgments, awards, or payments, and need to satisfy their Medicare Secondary Payer (MSP) obligations.

A timetable is given which provides for a Notice of Proposed Rulemaking to be issued by September 2019.   While no-fault insurance and worker’s compensation is mentioned in the notice, it is expected that any eventual rule regarding Medicare Set-Asides will be primarily applicable to liability.

CMS has gone down this road before, having issued an Advanced Notice of Proposed Rulemaking in 2012 which provided proposed options for considering Medicare’s interests in liability settlements. CMS ultimately withdrew its proposal, but in June 2016 announced that it was again considering expanding the WCMSA review process to liability. Notably, CMS included a provision in the contract with the new Workers’ Compensation Review Contractor for an expansion of reviews to liability. However, no such expansion can occur into there are rules and a policy in place to review what would be effectively Liability MSAs.

In regard to those rules, we are somewhat surprised by CMS proceeding the regulatory route. It was our expectation that CMS would follow a similar course as they have done with workers’ compensation, namely a voluntary review process in which a policy has been laid out through a series of CMS memos which culminated in a CMS WCMSA Reference Guide. CMS has either decided to proceed with the regulatory route for a policy pertaining to liability and future medical or they are keeping their options open.

Given the September 2019 date to have a NPRM issued, this signals that a final regulation would not even be in place until at least 2020. And as we have seen before (See below regarding regulations on penalties), the regulatory process can take many years.

Mandatory Reporting Penalties

The second notice issued by CMS through the OMB is titled Civil Money Penalties and Medicare Secondary Payer Reporting Requirements (CMS-6061-P) and states as follows:

Section 516 of the Medicare Access and CHIP Reauthorization Act of 2015 amended the Social Security Act (the Act) by repealing certain duplicative Medicare Secondary Payer reporting requirements. This rule would propose to remove obsolete Civil Money Penalty (CMP) regulations associated with this repeal. The rule would also propose to replace those obsolete regulations by soliciting public comment on proposed criteria and practices for which CMPs would and would not be imposed under the Act, as amended by Section 203 of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act).

While the verbiage in this notice is somewhat confusing, what this refers to is CMS is planning to issue a formal document requesting comments and proposed criteria for when CMS would impose what are called Civil Money Penalties (CMPs) for improper reporting or a failure to report under the Medicare Secondary Payer Act. As many will recall, the inducement for workers’ compensation, liability and no-fault carriers and plans to abide by the Section 111 Mandatory Insurer Reporting provisions was the possibility of a $1,000 per day, per claim penalty contained in the statute. However, since the start of mandatory reporting in 2010, no penalties have been issued.

Part of the reason penalties have yet to be issued is because the SMART Act of 2012 required CMS to issue regulations detailing the criteria for imposing penalties before CMS could take such action against what we know as Responsible Reporting Entities (RREs). In December 2013 CMS did issue an Advanced Notice of Proposed Rulemaking (ANPRM) to solicit comments and proposals for criteria under which Civil Monetary Penalties would be imposed under the reporting provisions of the MSP Act. A 60-day period was provided for stakeholders to provide comment to CMS. It was assumed that following this response period the regulatory process would move forward with a final regulation on the imposition of CMPs.

Surprisingly, post the comment period, no further action was taken by CMS. Five years later we now have this notice indicating CMS will once again solicit public comment on imposing CMPs. A due date is given of September 2019.

The implication of this notice is at some point between now and September 2019 CMS will publish a document requesting comment on the criteria for imposing CMPs for failure to comply with MSP reporting requirements. We will keep you apprised of any developments in this regard. Nonetheless, this is one area, penalties, where RREs are likely fine with CMS taking its time.

Lyrica is a brand name only medication which costs $8.91 per pill at 150mg. Over a 20-year life expectancy, this is close to $200K in an MSA allocation. Until recently, CMS largely excluded Lyrica from the MSA on the basis that the diagnosis for which it is being prescribed, typically neuropathic pain stemming from a lumbar injury, is considered non-Medicare-covered. Unfortunately, over the past three months, based upon MSA counter-highers received by Tower, CMS has seemingly begun to add Lyrica where a diagnosed condition of lumbar radiculopathy is present.

CMS Policy on Inclusion of “Medicare-covered” Medications in the MSA

Pursuant to the CMS WCMSA Reference Guide (Version 2.8), CMS will include causally related medications in the MSA under the following criteria:

Medically Accepted Indications and Off-Label Use

 For a drug to be covered under the Part D Benefit, and thus included in a WCMSA, it must be used for a medically accepted indication. A medically accepted indication is any use for a covered outpatient drug which is approved by the FDA or a use which is supported by one or more citations included or approved for inclusion in the recognized compendia.

Off-label use is when a drug is prescribed in a manner that is different from the FDA-approved product labeling. According to Medicare IOM 100-02 Chapter 15 Section, 50.4.2 – Unlabeled Use of Drug (Rev. 1, 10-01-03) B3-2049.3, “An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice. In the case of drugs used in an anti-cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in §50.5.” There are many off-label indications that are listed in recognized compendia and peer-reviewed sources; thus, they would be covered under the Part D Benefit, and should also be included in a WCMSA.

For example, trazodone is approved by the FDA for the treatment of major depressive disorder but is commonly given off-label to treat insomnia. So the WCRC would include trazodone in a WCMSA if used to treat insomnia if it is related to the workers’ compensation injury.

In summary, based upon this criteria, CMS’s practice has been to include medications in the MSA when either their use is for an FDA approved diagnosis or for a medically accepted indication as found in the “recognized compendia,” namely Micromedex’s DrugDex database or the American Hospital Formulary Service Drug. CMS cites the example of Trazadone which is FDA approved for major depressive disorder but is used off-label to treat insomnia. Insomnia is a medically accepted indication found in the DrugDex.

Inclusion of Lyrica in the MSA

In terms of Lyrica, the FDA approves its use for the following diagnoses:

• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain from a spinal cord injury
• Partial Seizure; Adjunct
• Postherpetic neuralgia

If any of the above diagnoses are present in a claimant’s course of injury-related medical care, Lyrica would be included in the MSA, if prescribed. CMS would also include Lyrica if a medically accepted indication was found in one of the two compendia.

CMS’s recent inclusion of Lyrica where it is prescribed to treat lumbar radiculopathy does not fit into any of the FDA approved uses or the medically accepted indications found in the compendia. While an FDA approved use is neuropathic pain from a spinal injury, a spinal cord injury is typically defined as traumatic damage to the spinal cord resulting in permanent changes in strength and/or sensation and other bodily functions. This is very different than the intervertebral disc degeneration or post-laminectomy syndrome which may typically be causative factors for lumbar radiculopathy. Consequently, it is unclear why CMS has determined Lyrica should be included for a diagnosis of lumbar radiculopathy.

Tower MSA has submitted Re-Review requests to CMS, but the response has thus far been their restating of the policy on inclusion of “Medicare-covered” medications in the MSA. What CMS is not explaining is how the policy applied to the FDA-approved uses or compendia identified uses for Lyrica establish the basis for inclusion of the medication in the MSA. The National Alliance of Medicare Set-Aside Professionals (NAMSAP), for which Tower is a member, has reached out to the senior CMS management for clarification of CMS policy toward Lyrica. As of the date of this article, no response has been received.

Practical Implications

As highlighted at the top of this article, the inclusion of Lyrica in the MSA can add a significant sum to the allocation. While CMS has yet to provide a clear explanation as to their actions or issue an official policy statement, the trend from MSA counter-highers points to Lyrica being included in the MSA when lumbar radiculopathy is diagnosed. As detailed above, Tower does not believe this is an appropriate interpretation of CMS’s own rules for determining whether a medication is Medicare-covered and thus included in the MSA.

Until such time as CMS clarifies its policy, Tower will continue to exclude Lyrica from MSAs where we have not identified a medically accepted indication, either as an FDA-approved use or as found in the recognized compendia. As our client, we will advise you of the potential of a counter-higher from CMS, but will continue to challenge any counter-higher we believe inappropriately adds Lyrica.

In terms of options where an MSA includes a diagnosis of lumbar radiculopathy for which Lyrica is being prescribed, they are as follows:

• Submit the MSA and risk a counter-higher;
• Settle without CMS-approval of the MSA;
• Await further challenges to CMS’s Lyrica policy to see if there is a rollback;
• Consider alternatives to Lyrica use; or
• Await Lyrica patent expiration for a price reduction when generics become available*

*While Pfizer’s patent on Lyrica was set to expire in December 2018, the FDA has extended it through June 2019 based on a program encouraging drug companies to demonstrate whether drugs have a pediatric use.

We will provide any updates which provide clarification as to CMS’s inclusion of Lyrica in MSAs. If you have any questions, please contact Dan Anders at (888) 331-4941 or Daniel.anders@towermsa.com.

On 10/1/2018, the Centers for Medicare and Medicaid Services (CMS) released updates to the Workers’ Compensation Medicare Set-Aside (WCMSA) Reference Guide, the Medicare Secondary Payer Recovery Portal (MSPRP) User Guide and the MMSEA Section 111 Medicare Secondary Payer Mandatory Reporting NGHP User Guide. These updates to the reference guide and user guides are all fairly minor, having minimal to moderate impact on the associated CMS MSP processes. A summary of the updates is provided below.

WCMSA Reference Guide

The WCMSA Reference Guide provides for most CMS policies pertaining to the review and approval of MSAs. Version 2.8 of the guide provides as follows:

HICN Replaced with MBI: As CMS explains:

As required by Section 501 of the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) of 2015, CMS must discontinue all Social Security Number (SSN)-based Medicare identifiers and distribute a new 11-byte Medicare Beneficiary Identifier (MBI)-based card to each Medicare beneficiary by April 2019. All fields formerly labeled as “HICN” have been relabeled as “Medicare ID” and can accept either a HICN or the new MBI.

Updated CDC Life Expectancy Table Link: While with this Reference Guide update CMS is not presently changing the CDC Life Expectancy Table used for calculating life expectancy in the MSA, CMS is updating the link which was outdated.

Revised Tables Pertaining to Verifying Jurisdiction and Calculation Method: In states where the fee schedule provides for regional adjustments, for example, New York, the Reference Guide lists criteria for determining the correct fee schedule rates to use in the MSA. CMS added an additional level of criteria and revised the table (9-1) that provides what is called an “Order of Precedence” in determining the zip code to utilize for pricing. CMS also added a table (9-2) clarifying pricing rules when claims are filed with U.S. Department of Labor Office of Workers’ Compensation Programs and states where no fee schedule is applicable.

MSPRP User Guide

The MSPRP is a web-based portal providing online access for attorneys, Medicare beneficiaries, insurers and authorized representatives to Medicare conditional payment information, the ability to dispute and/or appeal conditional payments and initiate the Demand Letter process among other tasks. Version 4.3 of the User Guide includes the addition of two new columns to the Case Results page providing for Case Status and Contractor, news fields which provide more relevant and updated information for claims awaiting response from the BCRC and three new warning pages to ensure information related to submitting redetermination, compromise or waiver requests is complete.

A notable improvement comes with the submission of Letters of Authority or Proofs of Representation allowing for third-party representatives, such as Tower MSA Partners, to act on behalf of insurers and Medicare beneficiaries. The process has been once a Proof of Representation or Letter of Authority is submitted through the portal the submitter would be required to wait a few days for the authorization to be authenticated. Updates to the MSPRP now allow authorizations to be uploaded to the portal with immediate authentication. As a result, the cuts down on the time to obtain Medicare conditional payment information.

Section 111 NGHP User Guide

CMS released Version 5.4 of the NGHP User Guide, which provides both policy and technical updates for the Section 111 Mandatory Insurer Reporting process. Notable updates are as follows:

• As a result of Angel Pagan replacing Jeremy Farquhar as the EDI Department Director, new contact information is provided.
• To ensure updates are applied to recovery cases appropriately, RREs are asked to submit the policy number uniformly with a consistent format. When sending updates, enter the policy number exactly as it was entered on the original submission, whether zeros or a full policy number (Section 6.6.5). 
• The excluded and no-fault excluded ICD-10 diagnosis codes have been updated for 2019 (Appendix I and Appendix J)

Practical Implications

We do not anticipate the changes to the WCMSA Reference Guide to have any impact on either increasing or decreasing allocations on CMS-approved MSAs. As noted above, the updates to the MSPRP authorization authentication process will improve the turnaround time for obtaining conditional payment information. Finally, the Section 111 User Guide updates are all minor in nature and have minimal impact on the reporting processes.

If you have any questions regarding these updates, please contact Dan Anders at (888) 331-4942 or Daniel.anders@towermsa.com.