Evolving CMS Controls on Opioid Prescriptions

Despite notable guidance available in other arenas, more than two thirds (69.4%) of California's submitted WCMSA proposals include extended funding for opioid medications. The statistic is startling considering that Medicare itself does not recommend using opioids for long-term use or chronic pain. The National Alliance of Medicare Set-Aside Professionals (NAMSAP) and the National Council of Self-Insurers (NCSI) have joined to review the situation and identify how the MSA industry can collectively address the nation's opioid crisis, and new opioid prescribing guidelines recently issued by CMS are designed to address the challenge, too.


Managing America's Opioid Crisis

Since 1999, the Centers for Medicare and Medicaid Services (CMS) have been tracking the growing opioid addiction crisis. Deaths caused by opioid overdoses have risen alarmingly in number, accounting for over 500,000 premature deaths between 2000 and 2014. Further, the number of prescription overdoses quadrupledin that timeframe, indicating that those using and abusing the drugs are frequently getting them from a legitimate healthcare professional and not a black-market street dealer.


From the CMS perspective, gaining control over the epidemic within the CMS beneficiary population has been challenging. CMS oversees the funding of healthcare servicesfor millions of Americans, including paying for the services of hundreds of thousands of healthcare professionals and their clinics, labs, and supporting facilities. CMS patients, including both Medicare and Medicaid beneficiaries, access CMS services through many portals, depending on their status and/or health condition. These various CMS systems have each grown independently of the others over time, so the rules governing one do not necessarily comport with the regulations of another. The resulting complicated matrix of directives, rules, and guidances makes it difficult to structure comprehensive regulations to govern any one issue (such as opioid management) that encompass and apply to all CMS departments. The opioid epidemic is now shining a light on how significant a challenge that complicated matrix poses to both CMS and its constituents.


NAMSAP and NCSI Highlight a Conflict

At its June 2018 annual conference, leadership for both entities presented data reflecting the apparent conflict in CMS documentation regarding opioid management. According to NAMSAP president Rita Wilson, the review policy for WCMSAs requires future, MSA-funded opioid prescriptions to match the dosage and frequency of orders posted within six to 12 months of the MSA submission date. However, Medicare Part D guidelines set out different directives, as do the evidence-based guidelines issued by the CDC. As the WCMSA guidelines stand now, the prescribers treating WCMSA beneficiaries are required to maintain opioid dosages and frequencies at unnecessarily high levels if they want their patient's WCMSA submission to pass the review process.


Opioid Management in Medicare Part D

In 2013, CMS issued a directive that shifted attention to the opioid concernto Part D sponsors. From that point in time, Part D sponsors were expected to identify and address opioid medication overutilization by implementing claims controls, signifying high-risk patient populations, and modifying case management practices to stem the flow of opioids into their patient base. The CMS then launched the "Overutilization Monitoring System" (OMS) so it could oversee compliance by those sponsors with the new directives. Although progress is slow, data reveals that opioid "overutilization" numbers are decreasing in the Medicare Part D population.


Notably, CMS is revising its Part D guidelines again in 2019 to continue improvements in that department. In April, CMS released its proposal for new guidelines(specifically directed at high-dose opioid prescriptions) to be included in its 2019 Medicare Advantage and Part D Rate Announcement and Call Letter. Those revisions include the expectation that all Part D sponsors will limit to seven days an opioid prescription for acute pain, and the expansion of the OMS to integrate it with the standards established by the 2016 Comprehensive Addiction and Recovery Act(CARA).


Opioid Management per the CDC

Also converse to the WCMSA policy is the CDC's guidance on opioid management, which balances the need for controlling chronic pain with the concurrent need to prevent opioid misuse disorder. Prescribers following the CDC recommendations will access opioid therapy only after other, less addictive therapies have been proven ineffective, and will start with a low dose, immediate-release opioid medication for a specified duration after discussing the challenge presented by opioid use to the patient. Further, physicians are encouraged to pursue regular reassessments over time to determine the continuing validity of the opioid as the preferred medication and to test for evidence of excessive opioid use. If or when they suspect an addiction has occurred despite their cautious use of the drug, the CDC also supports a referral for treatment of an opioid use disorder as early as possible. A subsequent survey indicated that almost 90 percent of surveyed doctors welcomed and would use the guidance.


California's Stats are Troubling - and Revealing

Despite the national awareness of the opioid problem and the various strategies in place to combat it, the California Workers Compensation Institute (CWCI) surveyreveals that it remains almost intractable, at least in that state's workers’ compensation cases. Released in October 2017 by the CWCI, the study paints a dismal picture of the future for more than two-thirds of the state's WCMSA beneficiaries. The group compared the statistics of WCMSA submissions in 2015 and 2016 with those of a closed control group consisting of similar cases with similar injuries. The data is disturbing:

  • Over 69 percent (69.4) of all California WCMSA's included funding for opioids specifically, more than double the volume of any other class of drugs;
  • Many of those opioid prescriptions were in significantly higher dosages than those in the closed cases, averaging 45 times the "morphine milligram equivalent" (MMEs) of the dosage found in the control group, and
  • the WCMSA cases proposed funding for the equivalent of 54.7 "morphine equivalents" (MEDs) per day for an average of 20.9 years.


Not surprisingly, two popular opioid brands, Norco and Vicodin, were prescribed in almost half the WCMSA cases (44 percent), and medication funding itself (for all medications) totaled almost half (47.6 percent) of all the included WCMSA submissions.


CMS is working hard to curb the opioid crisis within its Part D population, but the California survey indicates that its Workers’ Compensation sector is equally in need of that attention, if not more so. With the assistance of the CDC’s nuanced approach to the concern, CMS would do well to overhaul the WCMSA review rules to reduce or eliminate the egregious levels of opioids that continue to plague the WCMSA industry.