Many questions surround Formulary and MTUS updates proposed by California, relevant in all states considering treatment guidelines.
Phil LeFevre, Senior VP of ODG, an expert nationally on treatment guidelines, will present ODG analysis by Webinar on September 14th (Weds), at 11:00 AM Pacific (2:00 Eastern). Below are FAQs received by ODG since the announcement, including issues to consider when submitting comments to DWC by the deadline of September 16th (Friday).
A: California Assembly Bill 1124 requires adoption of a workers’ comp drug formulary by the Division of Workers’ Comp (DWC) by July 1, 2017, a tight timeline. DWC hired Rand to perform a study, which recommends updating the state’s Medical Treatment Utilization Schedule (MTUS), which is a mix of ODG and ACOEM guidelines. DWC agrees that it’s time for an update, and has so far updated the ODG portion last month, and is now considering similar updates to the ACOEM chapters.
Most importantly, DWC has also created their own MTUS Drug List (“MTUS Formulary").
Q: Is the proposed MTUS Formulary the same as the ACOEM Formulary, the ODG Formulary, or something else entirely?
A: It is neither ODG's nor ACOEM's new Formulary. It is a state-specific formulary, created by DWC. Their intentions are good, but stakeholders should understand what is happening, why it is happening, and the potential missed opportunity.
While the MTUS Formulary is being positioned as based on the ACOEM Guidelines, it is significantly different from the ACOEM Formulary marketed by Reed Group since November 2015. The differences are many (the Formularies have little in common), and I encourage stakeholders to compare them. There are many approved drugs on the ACOEM Formulary that are Non-Preferred on the MTUS Formulary.
Second, the “claim to fame” for proponents of the ACOEM Formulary is that it is diagnosis-specific, while ODG has indicated this approach is impractical from a regulatory standpoint. ODG’s position has been that while treatment guidelines must be diagnosis-specific (patient selection is applied in the clinician’s office and through UR), a Formulary must be a binary indicator. A pharmacist should not be expected to apply evidence-based treatment guidelines and patient selection criteria at the counter at Walgreens, when they simply have to determine quickly (yay or nay) if they need preauthorization before releasing a medication to a customer. DWC veered away from the ACOEM Formulary to use a binary indicator (Preferred and Non-Preferred), validating the ODG approach. This is consistent with the Rand recommendation that “condition-specific requirements be imposed sparingly” (Rand page xiii).
Q: Who created the MTUS Formulary?
A: The California Division of Workers’ Comp.
Q: Is the MTUS Formulary evidence-based?
A: It is not, and that is not a knock on DWC staff. They are highly educated, experienced, and qualified, but they do not have the resources to conduct an evidence-based process.
Evidence-based medicine requires a systematic review of the medical literature, ranking and weighting studies on their design and quality, and then sourcing the Formulary to that literature. That was not done by DWC in creating the Formulary, although they did list the chapter in the MTUS guidelines where they found discussion of each medication, but without any linkage or references. The elephant in the room is that the MTUS Formulary is in disagreement with the ACOEM Formulary, and both are suggested to be sourced from the same guidelines. Which is right? That is a mystery.
Q: Does the MTUS Formulary fulfill the requirements of AB 1124?
A: It most certainly does not. The main requirements of AB 1124 are that the formulary be evidence-based, nationally recognized, updated quarterly. We covered the evidence-based piece – it was not based on a systematic review of the medical literature. As for national recognition, this is a brand new formulary. It has never been put into practice, and up until last month, had never seen the light of day, so it’s most certainly not nationally recognized. As for updates, it is purportedly based on the ACOEM Guidelines, and per Rand, the ACOEM Guidelines are updated every 3-5 years (Rand page 34: “ACOEM Guideline revisions occur every 3–5 years”). That misses all three marks.
Q: Why didn’t they just use the ACOEM Formulary?
A: Rand confirmed the ODG format is preferable for a formulary. While the ACOEM Formulary is interesting in theory, it is unworkable from a regulatory standpoint (Rand page 31: “While the Reed Group markets its final product as a drug formulary, it is not a formulary in the traditional sense. A traditional formulary is a list of covered drugs with rules on how the drugs may be accessed and under which conditions”).
Q: Why didn’t they just use the ODG Formulary?
A: This is where things went awry. Rand’s primary recommendation is that the California Formulary be consistent with MTUS. While all formularies performed well, and ODG was acknowledged by Rand as the most proven in other jurisdictions and easiest to implement (Rand page 77: “For several reasons, the ODG formulary would be easier to implement. It is already in use by several WC programs and has been operationalized through NDC codes. The ‘Y/N’ structure of the formulary preauthorization rules makes it easier to operationalize because it does not require diagnostic information when processing most pharmacy bills”), Rand also noted that most of MTUS is currently ACOEM. Thus, the logic was they have to try to stick to MTUS.
Q: Do you anticipate problems with the MTUS Formulary?
A: It is new, unknown, and unproven, so at best, it is a gamble, and I would not advise playing dice with the world’s sixth largest economy. There are also many obvious reasons why it is suboptimal. Here are the top two-
1) The recent CWCI study reports that 78% of prescription drug payments in California will require preauthorization under the MTUS Formulary. That acts as a tax, delaying access to care on three of every four medications prescribed, which goes too far. ODG has twice as many preferred drugs, which have proven safe and effective when coupled with ODG guidelines, and thus do not need pre-authorization. This will further frustrate doctors from taking patients in the workers’ comp system, and increase the IMR backlog that has plagued the MTUS era with frictional costs.
2) The MTUS Formulary is merely a PDF file, and cannot be operationalized in its current state using NDC or GPI codes. Applying it will be like a trip back to the 1970s. We live in the age of automation, which is the only way for California businesses to compete on a global scale. Any formulary or treatment guideline must not only be easily searchable and sortable (this one is not), with links to the supporting treatment guidelines (not available), but also accessible and automatable by API, or Application Programming Interface (not even close). We receive over one million API calls PER DAY to the ODG servers from healthcare providers, PBMs, insurance carriers, and TPAs, using medical codes to determine medical necessity and RTW data in real-time. Manufacturers release hundreds of new NDCs each month, which get rolled into the ODG database. None of these things can happen for the MTUS Formulary, which is simply a static PDF file.
Further, keeping a product like this up-to-date is an impossibility for a state agency. Editorial control for the MTUS Formulary also remains mystery, given copyright questions and multiple parties claiming credit.
Q: Is there a better solution?
This is a huge opportunity to fix what has been wrong with MTUS for 13 years, namely that it is an amalgamation of outdated guidelines that are not easily integrated or operationalized. The success with ODG at the state level (better RTW outcomes, by 13-35%, and lower costs, by 30-50%, in TX, OH, ND, KS, OK, NM, AZ and TN) is not simply because we have the most comprehensive, evidence-based, multidisciplinary, and up-to-date treatment guidelines available, but also use state-of-the-art application tools to apply them efficiently, ensuring quality care quickly, while using managed care judiciously. That cannot happen with old PDF files from different sources slapped up on the Internet.
We are 13 years into the MTUS era, and California is still the highest cost state, with poor health outcomes, and frustrated doctors. Is it not time for wholesale change?
The better solution, frankly, is to adopt ODG (guidelines and formulary) system-wide, to unleash stakeholders to use the one solution proven to work best in multiple jurisdictions, and already integrated with claims, medical management, and UR systems. ODG is the most widely used workers’ comp guideline in the world, for good reason. The academic evidence and reports from successful adoptions in other states is overwhelming.
Q: Why does this matter outside of California?
A: This is the age old debate of state-specific guidelines/formulary, versus a nationally recognized solution. We need to spread the word not just in California, but across the country. Evidence-based medicine does not vary from state to state, no more than the acceleration of a falling object due to gravity, or the atomic number of helium. For a well-functioning system, with good health and RTW outcomes, quality medical care, and low premiums, stakeholders should demand a proven solution. With guideline adoptions in more than 15 states over the last 15 years, it is clear what works and what does not in the ODG, ACOEM and Frankenstein (state-specific) debate.
Remember, you cannot reinvent the wheel, without changing the design. Don't reinvent the wheel.
Q: What should stakeholders do?
A: Make your voice known. Submit comments to the Open Forum posted at the DWC site, and hurry. The due date is Friday, 09/16/16.
Call to action:
Alert DWC on what solution is proven to work best in your experience. This is not simply an opportunity to fix the proposed Formulary, but all of MTUS. Think big, about the best system-wide solution in your mind, be that ODG, ACOEM or Frankenstein.
Don’t miss this opportunity, for one week only. Historically, Forum comments have resulted in revamped regulations by DWC to better the system, but they do REQUIRE PUBLIC SUPPORT to make the changes rather than passive acceptance. This is an opportunity to get on the record, and talk about real solutions.
DWC is full of intelligent, qualified, pragmatic people, who asked for feedback and will not cling to a bad idea in the face of evidence to the contrary. They are expert regulators, but they need to hear from you, the expert guideline users.
When this window closes, it closes for a long time.
Q: Are you not self-interested, and can stakeholders trust you, Phil?
A: Thank you for taking the time to get this far, and yes, like everyone, of course I am self-interested. What I like most about working and growing with ODG over the last 16 years is that we have aligned our interests with improving the workers’ comp system in California and elsewhere. We cannot be successful without doing that, and thankfully, we have earned ample opportunities to prove our merit along the way.
This is a story that I and others like the late Dave Depaolo have been telling for a long time. I am the one who revealed that device lobbyists were writing content for the Louisiana Medical Treatment Guidelines, and the same guy who has been writing your “ODG Update” emails for 15 years, who has always tried to be available to take your calls and reply personally. Maybe I was even the young Account Exec on your ODG installation many years ago, or the one who trained your staff.
Whatever our connection, my job is to tell you what I would want to know, if our roles were reversed. To me, that means gaining your trust, only by being right.
Expertise is hard won, and always comes with a track record. Look long and hard at it, because it predicts the future.
And if you have a story about guidelines that improve outcomes in workers’ comp in California, let your voice be heard, and be specific. Then join our Webinar below.
Thanks again, and be well!