UR Nation End of Month Regulatory News Summary

| | Technology & Integration, Utilization Review

DEA Wants to Reduce Manufacturing Quota for Opioid Medications

The U.S. Drug Enforcement Agency (DEA) gave notice that they have proposed reducing the manufacturing quota for opioid medications for a third year in a row. The proposed 10 percent reduction for 2019 follows decreases of 5 percent in 2018 and 35 percent 2017. The DEA wants to make enough opioid product available for legitimate use, while restricting excessive amounts that may be diverted for illegal use.

Dr. Robert Goldberg, chief medical officer and senior vice president at Healthesystems, said the DEA’s quota reduction is a recognition that too many opioids are being manufactured, saying, “We could probably cut quantities of opioids by half, and still have enough to take care of all of us.”

Illinois Governor Bruce Rauner Signs SB 336 Medical Marijuana Law

Illinois Governor Bruce Rauner signed SB 336, also known as the Alternatives to Opioids Act of 2018. The bill expands access to medical marijuana by establishing a pilot program under which physicians may prescribe medical marijuana for patients who are taking opioids or have a condition for which opioids could be prescribed. While the bill does not exclude workers’ compensation patients from access to medical marijuana, it’s unclear how many employers and carriers would agree to pay for medical marijuana, since they are not required to do so. Currently, no commercial or state created treatment guidelines recommend medical marijuana.

Massachusetts HB 4742 Opioid Only Formulary Fails

HB 4470 was changed, with bi-partisan effort, to limit opioid prescriptions to injured workers and act as an “opioid only formulary.” Then HB 4470 was rolled into HB 4742. However, at the end of the 2018 legislative session, all of the “opioid only formulary” language was removed from HB 4742. What remained is language that assists in efforts to wean injured workers off opioids, improve access to non-opioid pain management, and increase access to Narcan by allowing pharmacies to dispense it without a prescription. Needless to say this was a big blow to system participants who were supporting the idea of an “opioid only formulary” in Massachusetts.

John Murphy, president of the Insurance Federation of Massachusetts, said “We would have been pleased if the language had stayed in.”

Frank O’Brien, vice president for state government relations for the Property Casualty Insurers Association of America, said, “It’s disappointing that statutory authority for establishing an evidence-based drug formulary was stripped from the bill.”

Marguerite Seidel, with the American Insurance Association, said, “We supported the creation of a formulary and were disappointed that it wasn’t part of the final package.”

Pfizer Seeking 6 Month Extension on Lyrica

Pfizer has requested that the FDA delay the patent expiration of Pfizer’s Lyrica by 6 months. Lyrica, a first-line medication for treatment of neuropathic pain, ranked number 1 in terms of per-user, per-year, in the Express Scripts 11th Edition of their Drug Trend Report. Pfizer is seeking the 6 month extension under what is called the ‘pediatric exclusivity’ provision. This is a provision whereby the FDA grants an addition 6 months before patent expiration as an incentive for drug companies to study the effects of certain drugs on children.

Scientists Developing Polymeric Materials that Repair Traumatized Human Organs

At a laboratory in St. Petersburg scientists are working on the development of three-dimensional porous materials made of collagen and chitosan. The polymer matrix is implanted into damaged liver tissue, bones or blood vessels. Since the materials are made from collagen and chitosan the body is tricked and does not reject them as a foreign object. Over time the matrix decomposes but not before it is covered by natural tissue. The researchers are also working on wound covers, prostheses of blood vessels, and suture threads, in addition to tissue engineering and cellular transplantation.

Vladimir Yudin, head of the laboratory, said “Experts are currently debating whether it is better to use an implant or restore the organ. A person with an artificial organ must take mediation for the rest of their lifetime to prevent the body from rejecting it. This is not the case for tissue grown from human cells.”

Texas Department of Insurance Seeking Input for Planned Audit of Neuromuscular Testing Referrals

From time to time, the Texas Department of Insurance (TDI) audits providers who treat injured workers. In the past, for example, they have audited doctors’ prescribing habits, finding that a number of physicians prescribed an excessive number of opioids and failed to keep adequate records, resulting in significant fines.

This time around they are planning to audit neuromuscular testing referrals. It is unclear at this juncture if TDI or workers’ comp carriers have noticed a surge in neuromuscular testing procedures in the past year or so. But something has caused TDI to initiate this planned audit.

Tom Swiatek

Tom Swiatek

As Assistant Vice President of Regulatory Services, General Counsel, and Editor in Chief of UR Nation, Tom Swiatek draws on his experience as an insurance attorney on both the general liability side, as well as on workers’ compensation matters. As a California Workers’ Compensation Section Member, Tom is leading the discussion with respect to the regulatory challenges and opportunities facing the workers’ compensation system.