UR Nation End of Month Regulatory News Summary

| | Evidence Based Medicine, Technology & Integration, Utilization Review

California to Delay Implementation of Drug Formulary

The CA DWC has confirmed that implementation of the workers’ comp drug formulary has been delayed to January 1, 2018. The initial public comment period was May 1, with two dozen separate organizations providing 119 pages of feedback. Many of the comments centered on whether there would be enough time for system participants to implement the formulary in their business operations. As you may remember, on May 17, Peter Melton, spokesman for the CA DWC, said the agency was “seriously considering” delaying the implementation date. So UR Nation was expecting, and welcomes, this news.

Optum Workers’ Comp was among the system participants who also welcomed the news. In a statement, Optum called the delay one of “wisdom and prudence,” and said “the anticipated delay is deliberate and serves to allow time for stakeholders to program the necessary changes, as well as provides California Division of Workers’ Compensation leadership time to educate physicians and injured workers on how the formulary is intended to work.”

FDA Asks Drug Company to Pull Opana ER Because of Abuse

For the first time ever, the FDA has told a drug company to pull a painkiller off the market because it has a high potential for abuse.  In June the FDA made the request to the drug company Endo because users were taking the extended release opioid and crushing it and injecting it as part of a widespread drug abuse pattern.  In addition, the FDA has noted that injection abuse from Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as people using the drug often share needles.

Endo, for its part, is pushing back, claiming the drug is safe if used as directed. They have said “Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.” However, the FDA has already said that if Endo does not voluntarily pull the drug from the market, it will withdraw FDA approval of Opana ER.

Healthy California Single Payer Health Care Bill Held Over to 2018 Legislative Session

SB 562, California’s “Healthy California” universal health care bill has been held in committee by Assembly Speaker Anthony Rendon, D-Lakewood. As reported in the Sacramento Bee, Rendon said that while he supports a universal health care bill, the current bill appeared to be “more of a statement of principles” than a serious public policy proposal.  He hopes that by carrying the bill over to the 2018 legislative session lawmakers in the Senate will use the time to take the bill more seriously than they did before.

Rendon also said that part of his motivation to carry the bill over to 2018 were the threats levied by the bill’s supporters, including the California Nurses Association and individuals who call themselves “Berniecrats.” These people said they would lead primary battles against lawmakers who would not openly support the bill.

As stated earlier, if passed, “Healthy California” would have large implications for workers’ comp, including carriers, TPAs and UROs that do business in California, as SB 562 would presumably absorb the medical portion of workers’ compensation.

Looking at 2018, the big problem for Healthy California will likely be cost. Many have grave concerns about how California could ever pay for such a program. “How do we possibly pay for this thing?” asked Sen. Tom Berryhill, R-Modesto. “This seems to me like what we did originally with “Covered California” and we are going to just figure it out as we go… We don’t have the money to pay for this.”

Charles Bacchi, president of the California Association of Health Plans, said the bill would cause “dangerous disruptions in health coverage and quality of care” for millions of Californians.

One daunting fact is the bill’s estimated $200 billion in potential new spending is larger than the entire state’s annual budget of $180 billion.

TX DWC Proposes Rule Requiring Preauthorization for All Prescription Drugs Created Through Compounding

The Texas Division of Workers’ Compensation proposed a rule that would require preauthorization for all prescription drugs created through compounding. You may recall that back in 2011 when the Texas Formulary was created many system participants thought they did not close a loophole that allowed excessive amounts of compounded drugs. This was because compounds avoided the preauthorization requirements by simply containing “Y” ingredients (as listed on the ODG formulary). In other words, if the compound avoided “N” drug ingredients, then it would also not require preauthorization.

The proposed rule change would amend Sections 134.500, 134.530 and 134.540 of the rules to exclude compounded drugs regardless of the ingredients unless preauthorization was obtained.

TX DWC said in a memo “The division emphasizes that the proposed rule changes are not intended to prohibit the use of medically necessary compound medications in the workers’ compensation system. Rather, they are intended to ensure that injured employees have access to all health care reasonably required by the nature of the injury as and when needed.”

The division has to date only proposed the rule informally, meaning it has not started the public hearing process required by the Administrative Procedures Act. The rule would take effect 60 days after formal adoption.

Louisiana Gov. John Bel Edwards Signs Three Bills to Help Combat Opioid Addiction

The HB 592 formulary bill based on ODG was held in the Louisiana Senate committee as time ran out and never made it to Gov. John Bel Edwards’ desk. But three other bills did, and he signed them into law.

HB 192 will limit first time opioid prescriptions for acute pain to a 7 day supply. The law would also require doctors to explain to patients the risks associated with opioids and give them the option to be prescribed a smaller quantity.

SB 55 will require physicians to take continuing education on controlled substance prescribing. It will also require prescribers to check Louisiana’s prescription drug monitoring program (PDMP) before prescribing any opioid, and if the patient’s course of treatment continues more than 90 days.

HB 490 will require the Drug Policy Board to establish an advisory council on heroin addiction and opioid prevention and education.

Overall, we at UR Nation are very pleased to see that these bills passed. It would have been nice to see a formulary in place as well, but limiting first fills to a 7 day supply for acute pain and requiring physicians to check the PDMP will go a long way in helping to get the Louisiana opioid crisis under control.

New Report Shows Prescribing Larger Supplies of Opioids Increases Addiction

A new report by pharmacist Bradley Martin and colleagues from the University of Arkansas show that prescribing larger supplies of opioids early increases the likelihood of long term addiction.  The study looked at 1.3 million patients who had at least one opioid prescription from 2006 to 2015.  The study looked at patients from group health as well as workers’ comp.

The study found that about 13.5 percent of patients receiving a first time opioid prescription of 8 days or more were still taking opioids a year later. That number shot up to 30 percent for those patients who received a first time prescription of 31 days or more.

“This is one of the reasons states have enacted caps,” said Mark Pew, senior vice president at Prium. For example, just this month Gov. John Bel Edwards of Louisiana signed HB 192, which limits first time opioid prescriptions for acute pain to a 7 day supply.

The report also talks about the dangers of Tramadol. Tramadol was not on the DEA’s list of controlled substances until August of 2014. But the report notes that Tramadol has become a top five prescribed opioid. And although it’s perceived as being weaker, it is still addictive and potentially dangerous.

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.