Endo Pharmaceuticals to voluntarily withdraw Opana® ER

opana-er-85341864The FDA and the Endo International plc reached an agreement on July 6, 2017 to voluntarily withdraw its reformulated Opana® ER (oxymorphone HCL extended release tablets) from the market after determining the benefits of its use in patients no longer outweighs the misuse and abuse risks. Endo plans an orderly transition for patients to minimize treatment disruption and to ensure patients have time to work with their prescribers. Optum expects prescribers will review their patients’ current therapy, evaluate the continued need for ongoing opioid therapy and then choose their course of action. This new treatment plan may include either implementation of an opiate weaning schedule as a plan to discontinue opioid therapy for or to continue opioid therapy and begin the process of migration to a new medication. Should a claimant require continued opioid therapy, alternatives exist including a generic non-abuse deterrent formulation of oxymorphone extended-release tablets.

At this time, Optum highly recommends awaiting change of therapy to an alternative medication prior to submission of any Medicare Set Aside (MSA) to The Centers for Medicare and Medicaid Service (CMS) to avoid the possibility of inclusion of Opana® ER in the approved MSA. We are proactively reviewing previously completed (MSA) reports and current referrals and will notify clients whose MSA contains Opana® ER. This voluntary withdrawl provides an opportunity to help the prescriber in weaning or transitioning the claimant to another opioid regimen.

We offer a variety of clinical products and have a staff of pharmacists and nurses to assist claimants with a plan to render the most cost-effective treatment for the claimant while allowing for the best therapeutic outcome.

Note, at this point other formulations of Opana® will remain on the market; the only formulation slated for removal is the Opana® ER. Click here to view the Endo news release in reference to this matter.

CMS Expands Re-review Process

The long awaited update to the Workers’ Compensation Medicare Set-Aside (WCMSA) Re-Review process, as promised by The Centers for Medicare and Medicaid Services (CMS) in late December 2016, has arrived.

We reported in January through our blog entry, MSA Optimism for the New Year, CMS expected to update their Re-Review process sometime in 2017 to “address situations where CMS has provided an approved amount, but settlement has not occurred and the medical care that supported the approved amount has changed substantially”.  CMS released an update to their Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Portal User Guide on July 11, 2017 (click here to access the updated guide) which includes the much-awaited information, starting in section 12.4 (page 12-12) titled “Submit a Re-Review Request for an Approved Case”.

Previously there were two Re-Review options (1 and 2 noted below). Now, CMS adds a third option referred to as the “Amended Review”.

  • Option 1:  You believe CMS’ determination contains obvious mistakes
  • Option 2:  You believe you have additional evidence, not previously considered by CMS, which was available prior to the submission date of the original proposal which warrants a change in the CMS’ determination.
  • Amended Review:  You believe projected care has changed so much the new proposed amount would result in a 10% or $10,000 change (whichever is greater) in CMS’ previously approved amount.

CMS specifies only one Amended Review is permitted per case and another re-review cannot be requested if a request for an Amended Review is denied. The following criteria have to be met for a case to be eligible for an Amended Review:

  • The case must have been originally submitted between one and four years from the current date and cannot have a previous request for an Amended Review
  • Must result in a 10% or $10,000 change (whichever is greater) in CMS’ previously approved amount

CMS has also noted as part of the re-review request, you may change from brand-named medications to generic medications and drug types. However, this change cannot be the sole reason for your re-review request. You must include additional changes (such as changes in dosage and/or frequency, additional medications, or medications no longer taken) to qualify for a re-review request.

The Amended Review process is a welcome change and we feel it will be a great benefit to the industry. This new process allows cases that have a CMS approved MSA, but did not settle to be re-evaluated for a more appropriate allocation based on current medical status. Although the Amended Review is limited to files with CMS submissions between one and four years from the current date, it is still great news for the MSA industry and a step in the right direction. One further change we would like to see is a formal appeals system put into place.

We recommend carriers and Third Party Administrators (TPAs) evaluate open cases to verify if any would fit the criteria for an Amended Review if medical circumstances have changed since CMS submission. The new criteria may provide a chance to settle the case where previously it was held up.

We anticipate there will be the potential for many cases which have not settled to take advantage of the Amended Review process. This could result in a CMS backlog for a short time while the industry is evaluating their caseload for opportunities. We anticipate the outcomes and potential reductions will allow files, where settlement was precluded due to a large CMS approved MSA’s, to be resolved. Please continue to watch this site for additional updates, news or trends as this new process unfolds.

New Abuse-Deterrent Opioid Formulations Released

The Food and Drug Administration (FDA) released a notice in 2013, surrounding the long-time available acetaminophen (the active ingredient in brands like Tylenol®). This notice addressed two issues that would help to make acetaminophen-containing products safer for the ultimate consumer by limiting their exposure and drawing a connection to their risks. The first was a call to limit the amount of acetaminophen in prescription combination products to 325mg per tablet, capsule or other unit of dose. The second required updated labeling to include liver toxicity warning. This bulletin gave the manufacturers until January 14, 2014, to comply by removing medications containing more than 325mg of acetaminophen from the market.

Prescription combination products containing acetaminophen are frequently prescribed for workers’ compensation injuries, most commonly those with opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet®) and hydrocodone (Vicodin™, Norco®). As a result of the FDA restriction on acetaminophen, manufacturers reformulated their combination acetaminophen products (i.e. Vicodin 5/500mg (hydrocodone/acetaminophen immediate release) tablet to Vicodin 5/300mg). Other manufacturers began releasing new opioid products containing no acetaminophen (i.e. Zohydro® ER, Hysingla® ER, both hydrocodone extended release formulations).

With these new releases came concerns. Critics of the new single opioid formulations feared they would lead to more abuse, misuse, and deaths due to the removal of the acetaminophen. In other words, excessive use of acetaminophen would no longer be a deterrent for patients tempted to take the medications at higher doses than prescribed and it remained to be seen what steps would be taken by manufacturers to guard against abuse and misuse of these products. As part of the FDA’s strategy to address the opioid abuse epidemic, they encouraged manufacturers to produce abuse-deterrent formulations.

Recently there have been several new single opioid formulation products, containing no acetaminophen, approved by the FDA and released to the market. All have some form of abuse-deterrent property.

Arymo™ ER (morphine sulfate extended release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, $5.18/tab*, 30mg, $10.38/tab*, and 60mg, $20.76/tab* strengths.

Vantrela™ ER (hydrocodone bitartrate extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 15mg, 30mg, 45mg, 60mg, and 90m strengths.

Xtampza® ER (oxycodone hydrochloride extended-release) abuse-deterrent capsule: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 9mg, $4.42/capsule*, 13.5mg, $6.51/capsule*, 18mg, $8.26/capsule*, 27mg, $11.49/capsule, and 36mg, $14.15/capsule*strengths.

Troxyca® ER (oxycodone hydrochloride/naltrexone hydrochloride extended-release) abuse-deterrent tablet: FDA approved for the treatment of chronic severe pain in patients who require daily, around-the-clock, long-term opioid treatment. Available in 10mg/1.2mg, 20mg/2.4mg, 30mg/3.6mg, 40mg/4.8mg, 60mg/7.2mg and 80mg/9.6mg strengths.

Roxybond™ (oxycodone hydrochloride immediate-release) abuse-deterrent tablet: FDA approved for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Available in 5mg, 15mg, and 30mg tablets.

*Centers for Medicare and Medicare Services (CMS) pricing utilized if available. Pricing at time of this article was not available in Redbook or CMS portal for all other medications.

Even though these abuse-deterrent formulations will not prevent consumption of large doses of opioids, the most common method of abuse, they do have one or more properties that make their non- therapeutic use less rewarding and more difficult. All, except Troxyca, utilize a physical and chemical barrier to deter abuse by cutting, crushing, grinding, or breaking for intravenous or intranasal use, while Troxyca utilizes the addition of an opiate antagonist to block the patient from experiencing the opiate effects of the medication.

Opioids have a long history of being utilized to treat pain in workers’ compensation injuries and while they are considered safe and effective when properly utilized they also have a high potential to lead to abuse, misuse, and addiction. This can lead to health risks for the injured worker and increased medical expenses over the life of the claim for the carrier. Therefore, it is imperative that carriers and Third Party Administrators (TPAs) take proactive measures to quickly get control of cases where they suspect fraud, misuse, and abuse in the early stages of the patient’s treatment. However, even at the final stage of the claim when the patient is rendered to be at MMI (Maximum Medical Improvement) and settlement is being discussed, there is still an opportunity to take advantage of clinical programs available to address inappropriate narcotic prescribing or abuse and misuse at the time. Optum Settlement Solutions offers a variety of clinical products and has a vast staff of pharmacists and nurses to assist clients with a plan to render the most cost effective treatment for the injured worker while allowing for the best therapeutic outcome.

You Are Being Watched

All non-group health plans (NGHP) including all property & casualty insurers who insure auto no-fault (Med Pay/PIP) claims, workers’ compensation claims, premises Med Pay claims, get your assumption and/or termination of ongoing responsibility for medicals (ORM) reporting in order, a firm called MSP Recovery is coming after you. A recent 11th Circuit decision in MSPA Claims 1, LLC v. Ocean Harbor Casualty Insurance (Case No. 2015-1946-CA 06) is granting class certification paving the way for recovery of millions of dollars for Medicare or Medicare Advantage plans nationwide.

According to a recent article in Daily Business Review, MSP Recovery, LLC, has the ability to determine if someone who has an incident, such as a car accident or a slip-and-fall and an insurance carrier has reported assumption of ongoing responsibility of medicals (ORM) to the Centers for Medicare and Medicaid Services (CMS) for primary payer responsibility .

MSP Recovery, LLC has developed a sophisticated system to identify no-fault claims by collecting and matching data including CMS reports, police reports, ambulance transport records, insurance declaration sheets, and no-fault personal injury protection/medical payout sheets.

MSP Recovery, LLC plans to file lawsuits across the country on behalf of many Medicare Advantage plans (MAPs) to recover conditional payments in which an applicable plan has demonstrated responsibility to pay by assumption and reporting to CMS of ORM.

Your Data is Being Mined

Presumably, MSP Recovery, LLC is able to use the Medicare Secondary Payer Recovery portal (MSPRP) to identify specific Medicare beneficiaries that have had ORM reported from the police or ambulance reports.

For commercial general liability policies covering premises slip and fall cases, if there is a no-fault/med pay policy provision, then the applicable plan is required to report ORM via Section 111 mandatory insurer reporting (MIR). If a med pay claim is made by the Medicare beneficiary after being treated, these claims can be identified via an ISO Claim Search subscription.

Since compensable workers’ compensation claims involving Medicare beneficiaries are required to report to CMS assumption of ORM, state departments of industrial relations may be accessed as well.

What do I do to avoid being brought into a Class Action?

Do not assume and report ORM if a no-fault claim has not been made by a Medicare beneficiary, where no treatment is sought, or if there is a legitimate statutory or coverage basis for the claim denial.

Do not forget to report to CMS an accurate ORM termination date. ORM should be terminated when policy limits have been exhausted, the policy period has expired, when CMS has approved an MSA after settlement, when there is a settlement that included medical expenses, or where there is a judgment or arbitration award that has occurred that disposed of related medical expenses.

Do not ignore or refuse to pay Medicare or MAPs who have demanded or notified you of potential conditional payments you may owe.

When in doubt, consult us. For questions, please contact Optum Settlement Solutions Division at 888-672-7674 or contactus@helioscomp.com