On March 9, 2018, Florida’s Governor, Rick Scott signed a bill into law that will reduce the length of time allowed for certain opioid prescriptions. Florida’s House Bill 21, entitled Controlled Substances, increases regulation, training, and reporting required when controlled substances are prescribed and dispensed in Florida. It was designed to curb prescription opioid addiction and enacted into law while the nation and state continue to see both prescription and non-prescription opioid drug overdose deaths surge. When medically necessary, doctors will be able to prescribe up to seven-day supplies of some controlled substances like prescription opioids, but often, the new law will limit those type of prescriptions to three days at a time. The shorter prescription time period was described in a recent article as an “inconvenience worth saving 50,000 lives nationwide” by bill proponent, House Speaker Richard Corcoran R-Land O’Lakes.
Part of the bill will require doctors’ offices to check and report into a statewide drug monitoring database to reduce the likelihood that patients are engaging in “doctor shopping” by visiting different doctors to get multiple prescriptions for the same injury. The article mentioned that in Florida in 2016, there were 968 overdose deaths from prescription opioids alone, including 723 from oxycodone (brand name Oxycontin) and 245 from hydrocodone (brand name Vicodin).
On April 18, 2018, the Florida Board of Podiatric Medicine will be hosting a “Multi-Disciplinary” conference call/discussion regarding implementation of House Bill 21.
Date and Time of Call: April 18, 2018, 12:00 p.m.
People interested may call (888) 670-3525 with participant code: 7342425515
A copy of the agenda may be obtained here.
The Centers for Disease Control and Prevention (CDC) has well documented the nation’s opioid crisis and the dramatic rise in prescription and non-prescription opioid overdose deaths since 1999. Deaths from prescription opioids since 1999 seem to be outpacing the close to 4x rise in sales of these medications during this time period. Between 2015 and 2016, opioid overdose deaths rose over 27%.
The risk of addiction and its consequences may be higher than people realize. The CDC’s website indicates that in 2014, almost 2 million Americans abused or were dependent on prescription opioids and that up to 25% of people who receive prescription opioids over a long term for noncancer pain in primary care settings struggle with addiction.
The Food and Drug Administration (FDA) seems interested in curbing opioid addiction. In late 2017, the FDA made two announcements regarding approval of medication assisted therapies (MATs) for opioid addiction., MAT uses other medications to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve people’s internal “cravings”, and normalize body functions. The FDA previously approved formulations of buprenorphine, methadone, and naltrexone for opioid MATs. More recently, the FDA approved the use of Sublocade™, a once-monthly injectable “depot” formulation of buprenorphine that allows for extended-release of the product over time. Sublocade is now available on the market.
Regarding Medicare Set-Aside (MSA) allocation reports that estimate future injury related, otherwise Medicare allowable medical expenses, including prescription drug expenses, the Centers for Medicare & Medicaid Services (CMS) sets some time limits on prescriptions of hydrocodone and oxycodone in its Pharmacy Guidelines – Section 22.214.171.124 of its recently updated Workers Compensation Medicare Set-Aside Arrangement Reference Guide Version 2.7 (WCMSA Reference Guide or WCMSA Guidelines – the only updates for which were a new phone number for the Workers’ Compensation Review Contract (WCRC) contractor that took over WCRC Medicare Set-Aside (MSA) reviews this month and a new clarified CMS confidentiality statement). While shorter than they used to be, these time limits are longer than those described in Florida’s new law. For example, Hydrocodone combination products, now classified as Schedule II controlled substances (C-II), require new prescriptions at intervals no greater than 30 days. In 2014 when they were classified as C-III controlled substances, new prescriptions used to last the earlier of five refills or six months. However, there is an exception for C-II drugs whereby practitioners may issue up to three consecutive prescriptions in one visit granting patients potential authorization to receive a total of up to a 90-day supply. WCMSA Guidelines changed on January 1, 2015, for all new cases submitted after that date to require at least 4 healthcare provider visits per year when C-II drugs are used continuously.
No recent prescription policy changes have changed the review process or recommended methods of preparing MSA allocation reports. Companies that prepare MSA allocation reports for Medicare beneficiaries or those with a reasonable expectation of becoming enrolled in Medicare within 30 months (claimants) will still follow CMS WCMSA Guidelines for usage for injured claimants’ life expectancies. While the WCMSA Reference Guide indicates that reviewers for the WCRC assess past pharmacy and medical history in cases of drugs prescribed on an “as-needed” (PRN) basis to determine “reasonably probable usage” for those drugs in the future, opioids for chronic pain management may be prescribed as an around-the-clock medication or PRN, depending on the situation.
CMS places a note in the subsection for “as-needed” prescriptions, reminding those preparing MSA allocation reports that “. . . non-compliance or non-adherence is not a reason to reduce a WCMSA amount.” There are currently no clear CMS guidelines providing a roadmap for reducing quantities (tapering) of prescription opioids over time to decrease the likelihood of addiction. The WCMSA Reference Guide states,
“Drug Weaning/Tapering Drug weaning commonly occurs with pain medications, such as opioids, especially when claimants’ work injuries improve. The WCRC takes all evidence of drug weaning into account, although in most circumstances the WCRC cannot assume that the weaning process will be successful. Usually, the latest weaned dosage is extrapolated for the life expectancy, but again, they assess all records when making these types of determinations. Where a treating physician believes tapering is possible and in the best interests of the claimant, CMS will consider all evidence in making a WCMSA determination, including medical evidence of current actual tapering.”
WCMSA Reference Guide 126.96.36.199 Version 2.7.
Let’s hope measures such as awareness education in provider and patient communities, reasonable prescription procedure changes and medication assisted therapies will all play a role in curbing opioid addiction among injured claimants and the U.S. population.
 Recent Notable FDA Approvals, December 13, 2017, Practical Law Legal Update w-012-1335.