Category Archives: News Bulletins

New Workers’ Compensation Review Contractor (WCRC) contract awarded

Capitol Bridge, LLC has been named the new Workers’ Compensation Review Contractor (WCRC) effective September 1, 2017, succeeding Provider Resources. Capitol Bridge is a Government Services firm headquartered in the Washington Metropolitan area with offices in Arlington, Virginia, Washington, D.C., and Columbia, Maryland.

Congratulations to Capitol Bridge and we look forward to working with you.

CMS’ newly updated WCMSA Reference Guide has arrived!

imageThe Centers for Medicare and Medicaid Services (CMS) released the latest update on July 31, 2017, of the Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide dated July 10, 2017. To view the reference guide click here. It contains some long-awaited good news for those jurisdictions with State-Specific Statutes, some clarification on several items and further information related to the new Amended Review process.

CMS provides information regarding what is required for approval when preparing a WCMSA according to State-Specific Statutes in Section 9.4.5 (page 24). They also throw out a warning to include this information in the initial submission and note, “Failure to include the required documentation at the time of original submission will not constitute a reason for the request of a re-review.”

Submitters requesting an alteration to pricing based upon state-legislated time limits must be able to show by a finding from a court of competent jurisdiction, or appropriate state entity as assigned by law, the specific WCMSA proposal does not meet the state’s list of exemptions to the legislative mandate. For example, this would apply to Georgia statute limiting future medical to 400 weeks for non-catastrophic cases here the date of injury is after July 1, 2013. While it appears CMS will now honor state statutes with time limits for treatment, a court order or finding confirming the claim does not meet the exemptions under the state law will be required.

CMS also indicates for those states where treatment is varied by some type of state-authorized utilization review board, the submitter shall include the alternative treatment plan from the treating physician confirming what treatment has replaced what was deemed unnecessary by the utilization review board. In California, carriers and Third Party Administrators (TPAs) will no longer be able to rely on the Independent Medical Reviews (IMRs) alone. Going forward, carriers and TPAs will need to seek an alternative treatment plan from the treating physician prior to submission of a WCMSA when treatment has been deemed unnecessary. It also brings up scenarios where no alternative treatment is necessary. If a claimant is receiving duplicate therapy, (such as two skeletal muscle relaxants) and utilization review deems the use of one of them as unnecessary there may be no alternative treatment or replacement for that treatment. In those instances, an argument may need to be made that no replacement is needed. CMS may require a statement from the treating physician to that effect as well.

Information regarding the previously released Amended Review process has been added under Section 16.0; please refer to our prior blog from July 13, 2017, with further details regarding the items needed for this type of review. This section points out several warnings

  • Only cases not yet settled as of the date of the request for re-review qualify for this re-review process;
  • “The approval of a new generic version of a medication by the Food and Drug Administration does not constitute a reason to request a new case review for supposed changes in projected price.” This cannot be the only reason/change for the re-review request;
  • CMS will deny the request for re-review if submitters fail to provide the required information and justifications referenced with the request for re-review. Submitters will not be permitted to supplement the request for re-review. CMS is confirming all required information must be supplied with the Amended Review request or the request will be denied.

Further clarification regarding hearing on the merits of a case in the context of whether the WCMSA should be submitted to CMS is found in Section 4.1.4. Because the CMS prices are based upon what is claimed, released or in effect released, CMS must have documentation as to why disputed cases are compromised and settled with future medical costs allocated for less than the recommended pricing. As a result, when a state WC judge or other binding party approves a WC settlement after a hearing on the merits, Medicare generally will accept the terms of the settlement, unless the settlement does not adequately address Medicare’s interests. This shall include all denied liability cases, whether in part or in full. For example, CMS is asking to see supporting evidence that the burden of proof was not met by the claimant, no causation medical evidence was proffered by the claimant within the statute of limitations period, a judicial decision ruled the employer/defendant was not responsible based upon findings of fact and law. If Medicare’s interests are not reasonably considered, Medicare will refuse to pay for services related to the WC injury (and otherwise reimbursable by Medicare) until such expenses have exhausted the entire dollar amount of the entire WC settlement. Medicare may also assert a recovery claim, if appropriate.

Spinal Cord Stimulator (SCS) pricing with CPT codes has been added to section 9.4.5. The reference guide goes into great detail on how to price a SCS appearing to suggest pricing for SCS will be different per jurisdiction going forward, instead of the same price for all states across the board, which has been the current allocation methodology utilized by the Workers’ Compensation Review Center (WCRC) up to this point. We will be monitoring this closely for any changes. CMS also differentiates the allocation differences between the non-rechargeable (every seven years) and rechargeable SCS devices (every nine years).

CMS has added a new section addressing changes in the submitter of record, found in Section 19.4, stating “CMS requires a written release from services by the original submitter and a new signed Consent to Release form authorizing the new submitter. Both must be provided in order to continue the WCMSA review process. Submitter changes will not be accepted after settlement.” This has been the process for quite some time but was not previously documented. It is our hope this will also apply to files having been previously approved by CMS but never settled, which in the past CMS has not always been honored.

Other minor changes/additions are found in the following sections:

  • Section 9.4.4 Medical Review: Step 5: Verifies jurisdiction and calculation method
  • Section 16.1 Required Resubmission: If a file is closed by CMS for a year or longer the initial submission will have to be re-done completely (start over)
  • Section 17.1 Administrators: CMS has added a sentence to this section recommending professional administration
  • Section 9.4.6.2 Pharmacy Guidelines and Conditions – Medically Accepted Indications and Off-Label Use: (clarification)
  • Section 10.4 Section 20 – Life Care / Future Treatment Plan: CMS has added the following sentence and made this section in the CMS portal a mandatory addition: “For the purpose of evaluating plan proposals, either a Life Care Plan or Future Treatment Summary is required for submission.”
  • Section 10.5.3 Total Settlement Amount: This section has been expanded with more detail of what the computation of the total settlement amount includes.

We recommend our clients review the updated reference guide to determine if any updates/changes apply to their specific cases. Please continue to watch this site for additional updates, news or trends from CMS as the above updates start to unfold.

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.

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.