New Part D Safety Policy Intends to Reduce Opioid Misuse

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

CMS recently announced its new Medicare Part D opioid safety policy, intended to reduce prescription opioid misuse. One aspect of the new policy is improved safety alerts at the pharmacy for Part D beneficiaries who are filling initial opioid prescriptions or receiving high doses. CMS cited the following three situations that would warrant an alert:

• Possible unsafe amounts of opioids.
• First prescription fills for opioids.
• Use of opioids and benzodiazepines at the same time.

CMS reports that if an alert is sent and if the prescription can’t be filled as written, including the full amount on the prescription, the pharmacist will give the beneficiary a notice explaining how they or their doctor can contact the plan to ask for a coverage determination.

The new policy also permits Part D plans to put drug management programs in place to help beneficiaries. One of the proposed ways that a Part D plan would accomplish this is given through the example that if a beneficiary gets opioids from multiple doctors or pharmacies, the beneficiary may be directed to receive such medications from specific providers or pharmacies to avoid overlap. However, the most notable part of this new plan is that the Part D plan will send the beneficiary a letter if it will limit their access to these medications under its drug management program. If so, the beneficiary and their doctor will have the right to appeal.

CMS acknowledges that “one size does not fit all” and that such policies do not apply to specific populations (i.e. long-term care facilities, individuals in hospice, palliative, or end-of-life care). To that end, additional material was provided for prescribers, pharmacists, and patients to clarify CMS’s interpretation of these policies.

Practitioner’s Note: While these policies are admirable in their attempt to curb the opioid issues within our country, it does beg the question as to what impact this will have in a clinical setting. With the example of the seven (7) day fill rule for new opioid users, in a majority of workers’ compensation and/or liability cases the beneficiary isn’t a beneficiary at the time of injury and the initial prescription of pain medication. As such, this policy would not apply to those individuals. Additionally, upon review of the additional materials for the providers and pharmacists, CMS specifically notes in bold “This alert is not a prescribing limit” and explains that decisions to taper or discontinue prescription opioids are individualized between patient and prescriber. How this policy may apply to the current Workers’ Compensation Medicare Set-Aside Reference Guide allocation methodology has yet to be determined.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

United States Sues Plaintiff Attorney, Medicare Beneficiary, and the Insurer for Conditional Payments in the Middle District of Pennsylvania

On February 26, 2019, the Middle District of Pennsylvania addressed a summary judgment motion brought by the United States against parties to a liability claim that involved a Medicare beneficiary and outstanding conditional payment liens.


The relevant background of the case is that a Medicare beneficiary (Beneficiary) was mistakenly given a medication from a pharmacy which resulted in a sixty-six day hospital stay. During this stay, the Beneficiary incurred nearly $100,000 in treatment bills. As the Beneficiary’s insurer, Medicare paid these bills, of which $84,353 was found to be related to the administration of the mistaken medication. The Beneficiary then filed a lawsuit against the pharmacy and medical care center, represented by Richard Angino of Angino Law Firm (“the Angino Defendants”). During settlement of the claim, the Angino Defendants requested the amount of charges that were paid by Medicare for the associated injury. The Centers for Medicare & Medicaid Services (CMS) reported back that $1,212 was paid. This was the amount that was ultimately relied upon at settlement.
As is the procedure, upon notification of settlement, CMS issued a demand of $84,353.00, but reduced it to $53,295.00, accounting for attorney’s fees. CMS also notified the Angino Defendants and the Beneficiary this amount was due in sixty (60) days. This amount was never paid.


CMS then filed a lawsuit under the Medicare Secondary Payer Act, 42 U.S.C § 1395(b)(2)(B) that as a matter of law it was entitled to $84,35.00 plus interest. A motion for summary judgement was filed by the defense. During this time, the Beneficiary passed away and in a separate action, the Beneficiary’s estate challenged the $84,353.00 and asserted that CMS was only due the $53,295.00. However, the lower court found that it did not have jurisdiction. Thus, the Plaintiff argued that Defendants lost their challenge and therefore owe the full $84,353.00. Defendants rebutted this argument on the grounds that although they cannot appeal the lower amount, they can challenge the $84,353.00. Additionally, Defendants claim questions of fact exist as to who would be responsible for payment of any potential excess owed.


Of note, the Defendants set aside the $53,295.000 and attempted to settle the conditional payments. However, CMS pursued litigation and increased the amount owed. As such, the Court agreed that a question of fact existed as to whether or not the Plaintiff had to pursue litigation to collect the amount due and justify raising the amount due. Plaintiff countered that the law provides that where Medicare “must file suit” to recover on the lien, they need not deduct attorney’s fees from the lien amount. 42 C.F.R. § 411.37(e). The Court responded that “at least with the facts which we are presented with, that whether or not the plaintiff had to pursue litigation is a question of fact.” (United States v. Angino, 2019 U.S. Dist. LEXIS 30499 (February 26, 2019).


As such, the Court found genuine issues of material fact and the summary judgement motion denied.


Practioner’s Note: This case is a reminder of the trouble parties can get into when not properly addressing the conditional payment liens associated with a liability claim. Remembering Shapiro v. Secretary of Department of Health & Human Services, 2017 U.S. Dist. LEXIS 42278 (March 23, 2017), the 2017 case mirrors the fact pattern at hand, in that the Beneficiary cannot rely upon the interim lien amount and Medicare is entitled to the final conditional payment amount issue after settlement of a claim.

Interestingly, this case has yet to determine who ultimately will be responsible for any excess payments over the $53,295.00. Also worth note, the Beneficiary’s estate, the Beneficiary’s attorney, and the Carrier were all parties to this action. This particular question could potentially have been avoided if only proper settlement language would have been included clarifying which party would be responsible for any overage. This is yet another prompt that settlement language continues to be an important piece to the settlement puzzle.


The Gordon & Rees Medicare Compliance Group will continue to monitor this case and bring you updates as they become available. Please contact me at (412) 588-2283 or rmaldonado@grsm.com should you wish to discuss this or any other Medicare Secondary Payer matters.

CMS Announces Webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP)

CMS  announced two webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP).

More to the point, the webinars will be addressing the fact that that effective April 1, 2019, electronic payment functionality will be added to both the MSPRP and the CRCP.  Taking place on March 13, 2019 for MSPRP users and March 14, 2019 for CRCP users, the webinars will provide more information on this new feature.

Practitioner’s Note: This enhancement could make paying outstanding Medicare conditional payments so much easier for debtors. Instead of sending a check and ensuring it’s applied to the proper claim, this function will hopefully give payers assurance that payment has been received and applied in a prompt manner and cut down on error when applying payments to claims that are not in final demand status. Additionally, it may be interesting to see how this may impact refunds as well.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

Medicare Coverage App Launches eMedicare

Yesterday CMS announced a new app to display what Medicare Part A & B covers. Per the announcement, “The new ‘What’s Covered’ app lets people with Original Medicare, caregivers and others quickly see whether Medicare covers a specific medical item or service. Consumers can now use their mobile device to more easily get accurate, consistent Original Medicare coverage information in the doctor’s office, the hospital, or anywhere else they use their mobile device.” Unsurprisingly, CMS discussed the need for this app as questions about what Medicare covers are some of the most frequent inquiries that CMS receives.

Interestingly, this app also is reported to enable beneficiaries to connect their claims data to applications and tools developed by innovative private-sector companies to help them understand, use, and share their health data.

As discussed previously, this innovation is in line with the directive from the current administration to move toward more electronic access in regards to healthcare. Specifically, this program is called eMedicare, and some of the purported goals are to allow beneficiaries to examine all available plans and see how different coverage choices will affect out-of-pocket costs.

Practitioner’s Note: This app could be extremely beneficial to beneficiaries who have had a MSA approved and are attempting to appropriately spend down their funds. Additionally, it will be interesting to see if the next version of this new app will include the option to compare Part C plans. Considering the narrative, ease of comparing different Part C plans appears to be an important part of the eMedicare program. However, this does beg the question what exactly is the “health data” they aim to share? 

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

The Ghost of Cases Past – MSPA Claims LLC, v. Scottsdale Insurance Co.

For those familiar with the slew of MSP Recovery cases that have been ruled upon in the past six (6) months, it will come as no surprise that another court, specifically the United States District Court for the Southern District of Florida, found that MSPA Claims LLC lacked standing when bringing suit against the Defendant.

Echoing the recently decided cases brought by MSP Recovery and its subsidiaries, the Court again in MSPA Claims v. Scottsdale Insurance found that Plaintiff lacked standing as proof of assignment of rights was not present and as such, granted Defendant’s motion for dismissal. Facts that are almost identical to MSPA Claims 1, LLC v. Ocean Harbor and MSPA Claims 1, LLC. v United Auto. Ins. Co., 204  F. Supp. 3d 1342, 1345 (S.D. Fla. 2016), Plaintiff asserted rights were assigned from Florida Healthcare Plus to La Ley Recovery which then assigned rights of recovery to MSP Recovery. The Court disagreed and specifically noted that although Plaintiff argued Florida Healthcare Plus approved assignment to La Ley to MSPA Claims, prior to receivership, the assignment did not predate the receivership. More pointedly, the Court stated it “is unclear how Florida Healthcare Plus could have approved the assignment…valid if MSP Claims was not yet formed as a company in 2014 when the receiver took over Florida Healthcare Plus[1].”

As such, the Court granted Defendant’s motion for dismissal without prejudice.

With yet another ruling dismissing a claim brought by MSP Recovery, the Floridian courts appear to sharpen their scrutiny regarding cases brought by assignees of rights by Medicare Advantage Plans. The pressing question however, is will other jurisdictions look to these cases as persuasive case law in their own courts? The Gordon Rees Medicare Group will continue to monitor these cases and bring you updates as they become available.


[1] MSPA Claims 1. LLC v. Scottsdale Ins. Co., 2018 U.S. Dist. LEXIS 218675

New Year, New Changes to the Workers’ Compensation Medicare Set-Aside Reference Guide

Today CMS issued an announcement that they have released Version 2.9 of the Workers’ Compensation Medicare Set-Aside Arrangement Reference Guide (Reference Guide), which can be found here. Per the new version, the changes included in this version of the guide are as follows:

  • To eliminate issues around Development Letter and Alert templates auto populating with individual Regional Office (RO) reviewer names and direct phone numbers, these will now display the generic “Workers’ Compensation Review Contractor (WCRC)” and the WCRC customer service number “(833) 295-3773” (Appendix 5).
  • Per CMS’ request, certain references to memoranda on cms.gov have been removed.
  • The CDC Life Table has been updated for 2015 (Section 10.3).
  • Updates have been provided for spinal cord stimulators and Lyrica (Sections 9.4.5 and 9.4.6.2)

The most noteworthy changes are those in regards to the spinal cord stimulators and Lyrica. In regards to the spinal cord stimulators, CMS specifically included in this version that “Routine replacement of the neurostimulator pulse generator includes the lead implantation up to the number of leads related to the associated code. Revision surgeries should only be used where a historical pattern of a need to relocate leads exist” …and “Surgery pricing may include physician, facility, and anesthesia fees. SCS pricing is based on identification of: 1.) Rechargeable vs. Non-rechargeable and 2.) Single vs. Multiple Arrays (leads). If unknown, CMS will default to non-rechargeable single array.” These pricing clarifications appear to be in line with the approved MSAs that CMS has approved over the last few months.

Lyrica has been a hotly discussed topic over the last few months. Those who are active in the industry have noted that Lyrica has been included more and more in many MSAs for conditions that are not related to a spinal cord injury, when this has been historically argued as an off-label usage. However, CMS seems to have quashed this debate with the release of the updated language regarding this prescription. Per the new update, “Lyrica (Pregabalin) is cited in MicroMedEx for an off-label medication use related to neuropathic pain from spinal cord injury, and a number of scientific studies indicate that Pregabalin shows statistically significant positive results for the treatment of radicular pain (a type of neuropathic pain). Spinal cord neuropathy includes injuries directly to the spinal cord or its supporting structures causing nerve impingement that results in neuropathic pain. Lyrica is considered acceptable for pricing as a treatment for WCMSAs that include diagnoses related to radiculopathy because radiculopathy is a type of neuropathy related to peripheral nerve impingement caused by injury to the supporting structures of the spinal cord.” In other words, a diagnosis of radicular/neuropathic pain would now support the inclusion of Lyrica in a MSA. Again, this has been in line with the recent approvals issued by CMS wherein this prescription medication has been included for radicular pain, such as radicular pain noted into the upper and/or lower extremity pain. However, in its attempts to clarify Lyrica’s accepted usage CMS has muddied the waters in the language when indicating “injury to the supporting structures of the spinal cord”. This could open the door to inclusion for conditions that are arguably unrelated to the spine simply because other areas of the body touch the spine. I.e. If prescribed for pain that originates not at the spine (ex. radicular pain from a shoulder injury).

The Gordon and Rees Medicare group will continue to follow this issue closely and will update you as soon as additional information is available.

Proposed Rule Regarding Section 111 Penalties Issued by Office of Management and Budget

Another notice relevant to the world of MSP compliance has been issued by the Office of Management and Budget. The notice, which was issued following the notice regarding Liability Medicare Set-Asides we previously reported on earlier this week, is titled “Civil Money Penalties and Medicare Secondary Payer Reporting Requirements” ,which can be found here. Per the abstract:

“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).”

Although this is only a Notice of Proposed Rulemaking (NPRM), this issue is expected to be decided upon in September 2019, corresponding with the Notice of Proposed Rulemaking for Liability Medicare Set-Asides as well.  Of note, the actual rule was not available for review.

The Gordon and Rees Medicare group will continue to follow this issue closely and will update you as soon as additional information is available.

Updated Life Table To Be Used Starting January 2019

CMS recently issued a notification regarding the use of Life Tables in Workers’ Compensation Medicare Set Asides. Per the notice found here, CMS advised that beginning January 5, 2019 CMS will convert to the CDC’s “Table 1: Life Table for the total population: United States, 2015” for the Workers’ Compensation Medicare Set Aside life expectancy calculations. They then provided the link to said table here. Interestingly, comparing to the 2014 Life Table, the life expectancy in the updated table have decreased slightly. Ex.: An individual who is sixty-one (61) had a life expectancy in 2014 of 22.5 while the updated 2015 table shows a life expectancy of 22.4, which would be a whole year difference for MSA allocation purposes.

The Gordon and Rees Medicare group will continue to follow this issue closely and will update you as soon as additional information is available.

LMSA Rules by September?

Once again the possibility of regulations from the Department of Health and Human Services regarding Liability Medicare Set-Asides (LMSA) and No-Fault Medicare Set-Asides (NFMSA) has been brought into the spotlight.  In recent days, the Office of Information and Regulatory Affairs’ Office of Management and Budget published a notice of proposed rulemaking to provide guidance to Medicare beneficiaries and to protect the Medicare Trust Fund.  The full notice can be found here.  Per the abstract:

“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.”

Interestingly, this proposed rule in regards to Liability Medicare Set-Asides (LMSAs) is noted to have “economically significant” priority. According to the Office of Management and Budgets, “significant” regulatory actions are defined in an executive order as those that: ‘Significant regulatory actions are defined in the Executive Order as those that have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive order.”[1] Furthermore, a Notice of Proposed Rulemaking (NPRM) is expected to be decided upon in September 2019. Although the actual proposed rule was unavailable for review, to those of us that are familiar with the industry, rules for LMSA and NFMSA have been anticipated for some time.  However, this is the first indication of movement outside the Department of Health and Human Services.

This posting by the Office of Management and Budget is the first step to development of regulation and is not yet a proposed rule. This publication is simply notification that CMS is currently in the process of putting together a proposed rule.  Once the draft is prepared it will be published in the Federal Register and after publication any interested parties in the rule will be provided 60 days to comment.  Once the period for comment closes, CMS will decide whether to proceed with development of the regulation.

It is unclear as to whether CMS will seek ongoing feedback from interested stakeholders. As of this date, no Town Hall has been scheduled.

Gordon & Rees has previously written official comments for prior notices of proposed rulemaking and is equipped to do so on behalf of interested stakeholders. If you are interested in this service, please contact us. As this process develops Gordon & Rees will continue to keep you apprised of the progress.

[1] Department of Management and Budget FAQs. https://www.reginfo.gov/public/jsp/Utilities/faq.myjsp

IDS Property Casualty Insurance Class Certification Reversed, Remanded

As previously reported, the Third District Court of Appeal for the State of Florida recently reversed and remanded the class action certification for MSPA Claims 1, LLC v. Ocean Harbor. On October 24, 2018, the same Court reversed and remanded the only other certified class action suit brought by MSPA Claims 1, LLC.

Citing Ocean Harbor specifically, the Third District Court again opined that in this case, MSPA has failed to establish that common issues predominate over individual issues. Applying the same rationale as Ocean Harbor, the Court noted “to quantify the claims of the putative class members will require a comprehensive and distinct analysis of each underlying PIP claim and automobile accident…Plainly this is one of those cases where merely proving entitlement to reimbursement from IDS for payments made by Florida Healthcare Plus on behalf of MA., in no way proves the cases of the other class members.” IDS Prop. Cas. Ins. Co. v. MSPA Claims 1, LLC, 2018 Fla. App. LEXIS 15107

The Court then went on to reverse as well on the alternate ground of standing. Harkening back to MSPA Claims 1, LLC. v United Auto. Ins. Co., 204  F. Supp. 3d 1342, 1345 (S.D. Fla. 2016), the Court ruled that the approvals of assignment did not occur until after the initial complaint had been filed. The parties in question did not assign benefits until June 1, 2016 as a part of a settlement agreement. However, MSPA filed its amended complaint on March 8, 2016, several months prior to the Receiver’s approval. As previously found, standing must exist at the inception of a case. As IDS had based its attack on standing on validity of the assignment, standing was not present[1].

As such, the Court reversed and remanded for proceedings consistent with the opinion.

It would be remiss to not point out that this was MSP Recovery’s only other certified class action suit. With its reversal and remand, the future of these class action proceedings seems dimmer and dimmer, at least in the Third District Court of Appeal for the State of Florida.

 

[1] The court does note that this case does differ from MSP Recovery LLC v. Allstate Insurance Co., 835 F. 3d 1351 (11th Circ. 2016) which similarly argued lack of standing. In that IDS argued that MSPA’s private cause of action against IDS was barred by the federal anti-assignment statue. This was rejected by the Eleventh Circuit.