After FDA Authorization, Lots of Pressure to Rescind Zohydro ER Approval

Nahla RizkallahIn October 2013, the U.S. Food and Drug Administration (FDA) went against the recommendation of its own advisory committee and approved Zohydro® ER. The FDA’s Anesthetic and Analgesic Drug Advisory Committee of independent experts voted 11 to 2 to recommend against approval of Zohydro® ER due to concern of the potential for abuse because the product does not include acetaminophen.

What is Zohydro® ER? It is a Schedule II controlled substance under the Controlled Substances Act. It is the first FDA-approved single-entity extended-release hydrocodone without acetaminophen. Zohydro® ER is FDA indicated for the management of pain severe enough to require around-the-clock opioid, long-term treatment and for which alternative options are inadequate. Zohydro® ER has black box warnings all of which can cause fatal overdose: addiction potential, life-threatening respiratory depression, accidental exposure, neonatal opioid withdrawal syndrome, and interaction with alcohol.

Since the FDA approval of Zohydro® ER, several members of congress protested by sending an open letter to Health and Human Services Secretary, Kathleen Sebelius. In addition, in November, attorneys general of 29 states and territories have sent a letter to the FDA asking that the agency consider reversal of Zohydro® ER. Most recently, a petition from more than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called upon the FDA to revoke its approval of Zohydro® ER. However, despite all the sharp criticism that the FDA has received, Zohydro® ER was launched on March 3rd, 2014.

So, why all the hype? Why so much attention and objection? This decision was surprising to many because as the country is in the midst of a prescription drug abuse crisis, the FDA failed to apply its current standard and goal of requiring abuse-deterrent technology for all opioids. Zohydro® ER does not have abuse-resistant technology. It can be dissolved or injected, and the opioid will get into a person’s system all at once.

Because of this and the greater risks with a new extended release opioid, Zohydro ER® is not recommended as a first line drug in the Official Disability Guidelines (ODG). It is classified as an ‘N’ by ODG which means it requires pre-authorization. It is likely that Zohydro ER® will be paid for by Medicare through a prior authorization process where documentation is provided to support that the patient has tried and failed several other alternative narcotics. Post-marketing studies on Zohydro® ER are being required by the FDA to evaluate the risk of misuse, abuse, addiction, overdose and death.

The average wholesale price (AWP) per capsule is as follows: 10mg is $6.59, 15mg is $7.03, 20mg is $7.24, 30mg is $7.46, 40mg is $7.67, and 50mg is $8.00. The FDA approved frequency for Zohydro® ER is every twelve hours.

Generally, Zohydro® ER is expected to drive up the cost of MSAs. However, as with all other forms of treatment and prescriptions, Gould & Lamb uses varied clinical tools, such as drug management reviews, to assist with mitigation of such costs.

Despite State Court Order, NJ Federal Court Finds Plaintiff Responsible for Conditional Payments

On June 12, 2013, the United States District Court for the District of New Jersey published its opinion in Taransky v. Sebelius, finding that the Court lacked subject matter jurisdiction over Ms. Taransky’s “due process” and “proportionality” claims, as Ms. Taransky failed to administratively exhaust these claims. Additionally, the Court concluded that despite state trial court’s order on a stipulation allocating settlement recovery to non-medical expenses, Ms. Taransky received payment from a “primary plan” responsible for payment of her medical expenses that had been covered by Medicare. As a result, Ms. Taransky is required to reimburse Medicare $10,121.15 pursuant to the MSP Act.

This case arose from a trip-and-fall accident that occurred on November 7, 2005 in Mount Laurel, New Jersey. Ms. Taransky was injured and, as a result, the federal Medicare program paid $18,401.41 in conditional payments.  Ms. Taransky sued the owners and operators of the shopping center on October 26, 2007, seeking damages for her personal injury losses. On October 26, 2009, Ms. Taransky settled the claims against these tort defendants in return for a lump-sum payment of $90,000.00.

Following the settlement, Ms. Taransky’s counsel filed a “Motion to Adjudicate Allocation of Settlement Proceeds” in the Superior Court of New Jersey, in Burlington County, that included a proposed order stating that “no portion of this recovery obtained by plaintiff in this matter is attributable to medical expenses or other benefits compensated by way of a collateral source.” In addition to the proposed order, Plaintiff’s counsel filed a “certification,” in which he stated that “New Jersey law does not permit a plaintiff’s tort recovery of losses (such as medical expenses) that have been compensated by way of collateral sources of benefits, such losses were not considered in settlement negotiations between the parties to this action and are not part of any recovery that may be obtained.” The state court entered the proposed order on November 20, 2009.

On December 8, 2009, the Medicare Secondary Payer Recovery Contractor, on behalf of the Centers for Medicare and Medicaid Services (“CMS”), sent Ms. Taransky a letter request that she reimburse Medicare $10,121.15. She disagreed and on January 4, 2010, Ms. Taransky sought redetermination from the Medicare Secondary Payer Recovery Contractor. The request was  denied by letter dated March 30, 2010. Ms. Taransky again sought redetermination of Medicare’s reimbursement decision, which a “Qualified Independent Contractor” affirmed via letter dated October 15, 2010. Ms. Taransky then proceeded before an Administrative Law Judge (“ALJ”) by way of telephonic hearing on March 9, 2011.

Ms. Taransky made the following arguments before the ALJ: (1) under the Medicare Secondary Payer Manual, Chapter 7, § 50.4.4, “the only situation in which Medicare recognizes allocations of liability payments to non-medical losses is when payment is based on a court order on the merits of the case” and that Medicare must defer to the state court’s allocation order because through its order, “the state court issued a decision on the merits of the case in which it allocated no part of the settlement to medical expenses or other benefits by way of a collateral source”; (2) the New Jersey Collateral Source Statute (“NJCSS”) “prohibits a plaintiff’s tort recovery from including any insured loss, apart from worker’s compensation and life insurance benefits” and as such, the Medicare payments were a collateral source and a New Jersey court would be legally prohibited from including them in any verdict; (3) Medicare is obligated to abide by the state court’s order; and (4) “reimbursement would be inequitable and that it would be unfair for Medicare to be ‘made whole’ for its expenditures from the already inadequate compensation received by the Beneficiary.”

The ALJ analyzed and rejected those arguments in its opinion issued April 15, 2011, finding that the state court’s order was not “on the merits” of the case, as it was issued pursuant to a stipulation of the parties and Medicare is therefore not required to defer to the state court’s order. Further, the ALJ determined that the NJCSS does not apply to conditional Medicare benefits. Therefore the Collateral Source Statute does not affect the Beneficiary’s legal obligation to reimburse Medicare. Thus, the ALJ rejected Ms. Taransky’s arguments and determined that she was liable for repayment of Medicare’s conditional payments.

Ms. Taransky appealed the ALJ’s determination to the Medicare Appeals Council (“MAC”), who rendered its decision on May 11, 2010, finding “no error in the ALJ’s decision.” Accordingly, the MAC adopted the ALJ’s decision “in its entirety” and added a discussion of a then-recently decided case, Mason v. Sebelius, No. 11-2370, 2012 U.S. Dist. LEXIS 40592, 2012 WL 1019131 (D.N.J. Mar. 23, 2012) (Simandle, J.) In addition, the MAC made a factual finding that “the $90,000 settlement in this case and the accompanying release of all claims against the defendants included compensation for medical expenses already paid for by Medicare with conditional payments.”

On July 16, 2012, Ms. Taransky filed the instant lawsuit, through which she asserted claims for “declaratory judgment and injunctive relief,” “violation of due process rights under the Fifth and Fourteenth Amendments to the Constitution,” and “for unjust enrichment.” Ms. Taransky also sought relief on behalf of a “class of all other persons similarly situated who had obtained tort recoveries subject to New Jersey law and were subjected to improper claims for reimbursement of Medicare out of their personal injury recoveries.”

On November 7, 2012, Defendants moved the Court to dismiss Ms. Taransky’s Complaint, or, in the alternative, enter an order of summary judgment in favor of Defendants. The Court heard oral argument in this matter on May 13, 2013. The Court’s findings are as follows:


1. Subject Matter Jurisdiction and Proportionality


In bringing their motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), Defendants asserted a factual challenge to the Court’s subject matter jurisdiction over Ms. Taransky’s claim “for violation of due process rights under  the Fifth and Fourteenth Amendments to the Constitution.” Defendants contended that 28 U.S.C. § 1331 does not confer jurisdiction over these claims that arise under the Medicare Act, and because Ms. Taransky has failed to pursue these claims through the Medicare administrative process, the Court does not have subject matter jurisdiction.

Plaintiff argued that her due process claims are properly before the Court because the basis for her constitutional claims “is not the adverse CMS administrative decision nor even the availability of the CMS administrative process per se,” but that “CMS administrative procedures fail to address the issue of its systemic disregard for the limits of statutory authority” and renders “those administrative procedures fundamentally flawed.” In contrast, Defendants direct the Court to Mason v. Sebelius, No. 11-2370, 2012 U.S. Dist. LEXIS 40592, 2012 WL 1019131 (D.N.J. Mar. 23, 2012), where Judge Simandle concluded that the claim was “one ‘arising under’ the Medicare act and the third sentence of § 405(h) therefore deprives the Court of federal question jurisdiction.” The Court agreed with Judge Simandle’s reasoning that this “due process” claim arose under the Medicare Act. Further, Ms. Taransky had ample opportunity to channel her constitutional claim throughout the administrative process, and she had not shown otherwise. Accordingly, the Court granted Defendants’ motion to dismiss Ms. Taransky’s Due Process claim.

Ms. Taransky argued for the first time before the Court that, under Arkansas Dep’t of Health & Human Servs. v. Ahlborn, 547 U.S. 268, 126 S. Ct. 1752, 164 L. Ed. 2d 459 (2006), Defendants’ entitlement to reimbursement should be “limited to the amount actually recovered by a beneficiary in respect of medical expense, or, where no such allocation is made, a proportionate share of the recovery.” Defendants contended that this argument was not properly before the Court because Plaintiffs failed to administratively exhaust the claim. The Court agreed. Its review of the administrative record reveals that Plaintiff did not raise her Ahlborn / proportionality claim during the administrative process, yet, for the first time, asked the Court to limit Defendants’ entitlement to Medicare reimbursement. Because Plaintiff had not administratively exhausted the claim as required under Section 405(g), it was not properly before the Court and the Court therefore lacked jurisdiction to consider it.


2. Medicare Reimbursement Claims

Defendants next sought dismissal or an entry of summary judgment on Plaintiff’s fully-exhausted claims for  “Declaratory Judgment and Injunctive Relief” and “Unjust Enrichment,” through which Plaintiff challenged the Medicare Appeals Council’s decision to uphold Medicare’s reimbursement claim. Specifically, Ms. Taransky sought from the Court a “reversal of the MAC decision; a judgment relieving her of liability to reimburse the Medicare program to that portion of her tort recovery representing the primary plan’s demonstrated responsibility for medical expenses covered by the program; and a refund of all monies improperly paid to defendants in respect of the Medicare reimbursement claim.” Ms. Taransky also asked for relief on behalf of a “class of all other persons similarly situated who had obtained tort recoveries subject to New Jersey law and were subjected to improper claims for reimbursement of Medicare out of their personal injury recoveries.”

Defendants asserted that they were entitled to an entry of summary judgment upholding the MAC’s decision and they again point to Judge Simandle’s opinion in Mason v. Sebelius, No. 11-2370, 2012 U.S. Dist. LEXIS 40592, 2012 WL 1019131, (D.N.J. March 23, 2012), which, as previously discussed, confronted many of the issues raised in this case. In Mason, Judge Simandle engaged in a thorough review of the MSP, the NJCSS, and New Jersey case law and ultimately found that the New Jersey Supreme Court would likely conclude that conditional Medicare benefits subject to reimbursement are not a collateral source under the NJCSS and therefore does not apply to exclude conditional Medicare benefits from a tort settlement or judgment.

The Court found that the MAC and ALJ properly addressed the issue of the state allocation order. The MAC adopted the ALJ’s decision in its entirety, including the ALJ’s conclusions with regard to the state court’s allocation order. In rendering its decision, the ALJ addressed Ms. Taransky’s attempt to apply the Medicare Secondary Payer Manual, Chapter 7, § 50.4.4 to her case, as she did again in arguing the instant case before the Court. This section provides, in relevant part, that “[t]he only situation in which Medicare recognizes allocations of liability payments to nonmedical losses is when payment is based on a court order on the merits of the case.” Ms. Taransky asserted, as she does here, that “through an Order to Adjudicate the Allocation of Settlement Proceeds, the state court issued a decision on the merits of the case in which it allocated no part of the settlement to medical expenses or other benefits compensated by the way of a collateral source” and Medicare must therefore recognize this allocation.

However, the ALJ properly rejected this argument, reasoning that, “on the merits’ means, a court order delivered after a court has heard and evaluated the evidence and the parties’ substantive arguments.” The ALJ determined that the state court’s order “was not made pursuant to a determination by a court of any substantive issue with respect to a primary negligence suit, including determinations regarding fault or damages” and “[i]nstead, the Order was issued pursuant to a stipulation of the parties” and “the Beneficiary cannot cancel out her legal duties through a stipulation with a third party.” Here, the Court found that the ALJ properly reached its conclusion that the state court’s order, entered upon a stipulation of the parties, did not constitute a “court order on the merits of the case” as contemplated under Chapter 7, § 50.4.4 of the Medicare Secondary Payer Manual. Accordingly, this conclusion, coupled with the MAC’s factual determination that the settlement included compensation for medical expenses already paid for by Medicare with conditional payments, which this Court must regard as “conclusive” under Section 405(g), lead the Court to affirm the MAC’s decision.

This case illustrates the fundamental principle that Medicare’s interests cannot be stipulated away by the parties to tort litigation. It reinforces Medicare’s rights as paramount despite judicial approval of settlement documentation. Additionally, it seemingly settles the issue regarding Medicare benefits as a collateral source in New Jersey, holding that conditional Medicare benefits subject to reimbursement are not a collateral source and therefore cannot apply to exclude conditional Medicare benefits from a tort settlement or judgment.

MSAs for Liability Cases? – CMS Publishes Timeline for Rulemaking

The Centers for Medicare and Medicaid Services recently published RIN: 0938-AR43 in follow-up to its Advanced Notice of Proposed Rulemaking, originally released on June 15, 2012 (read here). The original ANPRM solicited public comment on a proposed rule regarding  standardized options that CMS was considering making available to beneficiaries and their representatives to clarify how beneficiaries could “meet their obligations to protect Medicare’s interest with respect to Medicare Secondary Payer (MSP) claims involving automobile and liability insurance (including self-insurance), no-fault insurance, and workers’ compensation when future medical care is claimed or the settlement, judgment, award, or other payment releases (or has the effect of releasing) claims for future medical care.” The document provided seven options for satisfying Medicare’s interest when settling future medical benefits as a result of an injury or accident.

According to the Federal Register, 107 comments were received. Considering the importance and far-reaching ramifications of a potential rule to codify and require the parties to consider Medicare in all insurance cases, the number of comments was startlingly low. In fact, the lack of CMS activity with regard to the rule making may signal that the issue was not pressing enough for immediate action. In fact, no response to the comments were addressed or made by CMS until the publication of the RIN. In several public appearances since June of last year, CMS officials refused to discuss the issue, advising that they were “under rulemaking.” While their position is technically incorrect as the rule was simply a proposed notice, CMS nonetheless gave many the impression that activity around the issue was not a priority.

With the release of the RIN, CMS seems to signal that they are prepared to publish a Notice of Proposed Rulemaking which would include liability insurance cases. The deadline for action, however, is listed as “9/00/2013.” Accordingly, we may be able to expect something substantive in the very near future. Presumably, CMS has digested the comments provided by those that bothered to respond. By and large, those comments either questioned the statutory authority of CMS to implement such a rule, or lamented the broken, sometimes incomprehensible workers’ compensation MSA review and approval process.

While the RIN suggests a timeline for action by CMS, it must be remembered that the suggested timeline will not be enforced by any entity other than CMS itself or the Department of Health and Human Services. Considering the slow response that CMS and HHS have exhibited in formulating and releasing Congressionally-mandated regulations to implement the newly enacted Strengthening Medicare and Repaying Taxpayers (SMART) Act, it would not be unusual to see the September deadline come and go without a proposed rule.

Certainly, CMS action on these issues and implementation of a rule requiring injured plaintiffs/claimants to formally consider Medicare’s future interests in any injury or accident case, could fundamentally alter the way claims will be evaluated, litigated and resolved particularly with respect to liability insurance claims. Gould & Lamb will continue to monitor the situation and will provide updates or comment as the situation is further defined. If you would like to discuss these issues, contact your G&L representative or call our corporate office and an executive team member will be glad to assist you.


Louisiana Federal District Court Approves MSA Based on G&L Expert Testimony

Russell S whittle, Esq VP MSP ComplianceOn August 30, 2012, the Federal District Court of Louisiana, Western District, LaFayette Division, published its opinion in Bessard v. Superior Energy Services, finding that there was no evidence that Mr. Bessard, his attorneys, any other party or any other party’s representative, were attempting to maximize aspects of the settlement to Medicare’s detriment. As a result, the court concluded that to the extent that Mr. Bessard receives confirmation from Medicare of any conditional payments made by Medicare for services provided prior to settlement, Mr. Bessard shall promptly reimburse Medicare for such conditional payments. In addition, Mr. Bessard shall allocate $6,701.00 out of the settlement proceeds for payment of future medical items or services, which would otherwise be covered or reimbursable by Medicare, related to the conditions claimed and released in the case.

Gregory J. Bessard was injured in a workplace accident on June 30, 2009. His case was settled amicably after lengthy negotiations. The defendant agreed to pay the plaintiff the sum of $785,000. The settlement called for Mr. Bessard to assume the obligation for payment of his future medical expenses, which were to be calculated through a MSA.

Although Mr. Bessard was not a Medicare beneficiary at the time settlement was reached, Mr. Bessard was receiving Social Security disability benefits in connection with the injuries sustained in the accident. As a result, various medical reports were accumulated and a MSA was prepared by Gould & Lamb.

Based on the information provided by Mr. Bessard’s treating physicians, utilizing the fee schedule applied in claims brought under the Longshore and Harbor Workers’ Compensation Act, Gould & Lamb determined that Mr. Bessard’s future potential medical expenses that would be covered by Medicare and that were related to the injuries claimed and released amounted to $6,701.00.

Although the parties wanted the MSA approved by CMS for purposes of complying with the provisions of the MSP and the commensurate regulations, the parties were concerned that the settlement could not be finalized and cited the delays associated with obtaining approval from CMS and the possibility that approval may not ever be forthcoming.

In an effort to avoid jeopardizing the settlement and to achieve compliance with the provisions of the MSP, the plaintiff and defendant jointly filed a motion for Declaratory Judgment seeking (1) approval of the settlement, (2) a declaration that the interests of Medicare are adequately protected by setting aside a sum of money to fund Mr. Bessard’s reasonably anticipated future medical expenses related to the injuries claimed and released in the lawsuit, and (3) an order setting that amount aside from the settlement proceeds and depositing it into an interest bearing checking account to be self-administered by Mr. Bessard.

The Court set the matter for an evidentiary hearing and ordered service to be made by the Clerk of Court on the Secretary of Health and Human Services, the chief counsel of HHS/OGC for Region VI, and the civil chief of the office of the United States Attorney for the Western District of Louisiana. By letter dated August 20, 2012 from the office of the United States Attorney for the Western District of Louisiana, the Court was advised that HHS/CMS would not participate in the hearing.

At the hearing, the Court heard testimony from Patricia Kent, staff attorney with Gould & Lamb LLC, who was accepted as an expert in MSA/MSP issues, and who explained how the MSA evaluation was prepared. Although the most recent reports from the physicians treating Mr. Bessard did not state that additional diagnostic testing was necessary or that Mr. Bessard would require future visits with his physicians or additional physical therapy, the standard applied by Gould & Lamb in preparing the MSA was to consider all reasonably foreseeable medical expenditures.

The Court found that the methodology used by Gould & Lamb to calculate the estimated future medical costs, as set forth in the MSA, was both reasonable and reliable. The Court further found based upon MS. Kent’s testimony, that the future services listed in the MSA were reasonably foreseeable, adequately considered Medicare’s interests under the MSP, and the amount set forth in the MSA adequately protected Medicare’s interests.

As the premier and most trusted MSP vendor in the country, this case again highlights the usefulness and benefits of Gould & Lamb’s comprehensive array of MSP services. In addition to Mandatory Insurer Reporting, Conditional Payment Resolution, Medicare Set Asides, Post Settlement Account Administration, Prescription Drug Program, Future Medical Costs Projections, and Life Care Plan services, Gould & Lamb also offers Settlement Language Guide, Settlement Document Review, MSP Exposure Analysis, and Expert Testimony services.

Gould & Lamb provides its clients with Medicare Compliance Services and Programs focused on reducing claim costs and positioning claims for settlement. To this end, Gould & Lamb has prepared a Settlement Language Guide to assist insurers and self insured entities navigate the complex sea of Medicare Secondary Payer compliance. The guide contains language for possible claims settlement scenarios with a description and analysis of possible actions. Once the Conditional Payment or Medicare Set Aside issue has been brought to light, Gould & Lamb will assist with recommending MSP appropriate and protective settlement language. If you have already produced settlement documentation that contains such language, Gould & Lamb will review same and make recommendations on any needed changes, additions, or deletions. Gould & Lamb also offers our clients detailed and specific to the claim analysis of all Medicare Secondary Payer exposure issues that may exist in your case. Gould & Lamb’s extensive and experienced MSP legal team will provide a written analysis, including statutory, regulatory, and case law citations, that outlines any Medicare Secondary Payer exposure and recommends solutions to any discovered potential problems or issues. Gould & Lamb also provides expert advice on MSP issues, available to provide expert testimony on any MSP issue at meetings, mediations, depositions, hearings, trials, or any other event our client deems our expert analysis helpful or necessary.

Click Here to Download the MSP Compliance Protocols User Guide from Gould and Lamb

Download the MSP Compliance Protocols user guide today!


About the Author: Russell S. Whittle, Esq., is the Vice President of MSP Compliance for Gould & Lamb, LLC. In his twenty plus years of practice prior to joining Gould & Lamb, LLC, Mr. Whittle practiced primarily in the area of insurance defense, representing the interests of large insurers and employers in both workers’ compensation and general automobile liability matters.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.

General Information

The 67th Annual Workers’ Compensation Educational Conference and the 24th Annual Safety and Health Conference are just around the corner. Set for August 19 through 23, 2012 at the Orlando World Marriott, the conference will again focus on the national workers’ compensation and safety industries, serving as a gathering of national stakeholders to study and be educated on issues of common concern.  For the first time, the Conference program has expanded to a fourth day (Thursday, August 23) with a full 2-day breakout for mediators.

Program

As usual, this year’s program offers creative and innovative speakers from around the country. The hottest issues in workers’ compensation and safety will be discussed. All aspects of workers’ compensation and workplace safety will comprise the topics of discussion with breakouts for risk managers, regulators, safety professionals, health care providers, adjusters, insurance professionals, attorneys, medical case managers, professional employer organizations (employee leasing), temporary staffing, mediators, and medical office administrators.

Medicare Secondary Payer Act Compliance

Sponsored by Gould & Lamb, LLC, this year’s conference will again be the only national conference to feature a full-day breakout on the Medicare Secondary Payer Act and related subjects. One of the most difficult areas in handling workers’ compensation and general liability matters is understanding and dealing with the serious pitfalls that this expanding responsibility creates. The comprehensive breakout will clarify what has become an extremely complicated process that has created enormous issues for the workers’ compensation industry, soon to further expand into the general liability area.

Providing Clarity in a Land of Confusion

Program Moderator, Bret Cade, Executive VP of Sales at Gould & Lamb, LLC will lead the day long seminar. Planned presentations include Medicare Secondary Payer Act 101: The Reader’s Digest Version by Roy Franco, Esq., Principal at Franco Signor, LLC, The Eye in the Sky: Mandatory Insurer Reporting by Scott Huber, Vice President of Information Technology at Gould & Lamb, LLC and Jeff Gurtcheff, VP and General Manager at PMSI, Render Unto Caesar What is Caesar’s: Conditional Payments  Resolution by Wanda Reas, Esq., Partner at Znosko & Reas, P.A. and John Cattie with the Garretson Resolution Group, So Let It Be Written, So Let It Be Done: A Legislative and Case Law Update by Mark Popolizio, Esq., Senior Legal Counsel at Crowe Paradies and Roy Franco, Esq., Principal at Franco Signor, LLC, Seeing the Forest Through the Trees: MSA/LMSA Trends by Rafael Gonzalez, Director of Medicare Compliance & Post Settlement Administration at Gould & Lamb, LLC, Celia Mendez, Esq., Mediator & Attorney at Moreland & Mendez, P.A., and Cynthia Sage, Esq., Corporate Counsel at FCCI Insurance Group. The program will end with MSP Compliance in the Real World: A Roundtable Discussion where all of the previously mentioned speakers will be joined by Skip Brechtel, Chief Technical Officer at CCMSI, Wade McGuffey, Esq., of Goodman, McGuffey, Lindsey & Johnson, LLP, and the Honorable David Langham, Deputy Chief Judge of Workers’ Compensation Claims.

The program will:

  • Provide much needed technical information on Mandatory Insurer Reporting, addressing its purpose and expounding on reporting triggers, errors and challenges, as well as the consequences enumerated by Section 111 of the Medicare/Medicaid SCHIP Extension Act of 2007.
  • Present a comprehensive overview of the policies and procedures relative to the Medicare Secondary Payer Recovery Contractor (MSPRC), challenges in dealing with the MSPRC and consequences of not handling Conditional Payments appropriately.
  • Give attendees with a thorough review of new legislative initiatives and cases decided from around the country on both workers’ compensation and liability claims related to Medicare Set Asides and Conditional Payments.
  • Delve into current industry trends in workers’ compensation and liability Medicare Set- Asides, specifically regarding MSA submissions, MSA approvals, MSA pharmacy issues and MSA administration.
  • Offer those in attendance the opportunity to listen in on a roundtable discussion bringing legal and claims’ experts together to discuss their trials, tribulations, methods and best practices in complying with CMS’ policies to take Medicare’s interest into consideration when settling past and future medical care.