Tag Archives: bill review

9 Key Factors for Drug Formularies

These remarks were prepared for testimony at a recent Assembly hearing in Sacramento on California’s consideration of a workers’ comp drug formulary.

Thank you for the opportunity to be part of this hearing on the potential development of a prescription drug formulary in California. My name is Mark Pew, senior vice president of PRIUM, a nationwide medication management company based in Duluth, GA, that has conducted business in California for more than 15 years and been a utilization review organization since 2009. I have followed the development of workers’ compensation drug formularies in other states since 2010 and, through observation and dialogue and corresponding deployment of services, have come to identify success criteria. I spoke on the subject at the National Workers’ Compensation and Disability Conference in November 2012 and at that time opined that California should consider a drug formulary. Since 2013, I have had several conversations with various California stakeholders to further that discussion, so I’m very pleased to see progress being made towardsthat goal.

Because I value the time of this committee hearing, I will be brief in what I consider to be important foundational tenets when constructing a drug formulary. I will forego any statistics or rationale for a drug formulary as that has already been well articulated in the bill’s analysis.

  1. A drug formulary should be about better patient clinical outcomes, not cost. My opinion is that if you do what’s right for the patient, all other stakeholders win by side effect. While much of the discussion leading up to this hearing has been about cost savings, it would be shortsighted to think that should be the criteria for success. In my opinion, true success from a drug formulary would be a decrease in disability, a decrease in addiction and dependence, an increase in return-to-work and an increase in the use of less dangerous treatment options. If the focus is on better patient clinical outcomes, there should be no stakeholder in California workers’ compensation that can argue that this isn’t a good thing.
  2. A drug formulary should rely on evidence-based medicine. Robust clinical studies that indicate what drugs should be used when, and what non-pharmacological treatment options should be tried in advance, should dictate which drugs require additional evaluation before prescribing. There are some very dangerous drugs that are generic and inexpensive, so the trigger should be what produces the best clinical outcomes in proper sequence. Step therapy, the idea that you start with the most effective, least dangerous option, is built into evidence-based medicine and should be the template for prescribers. The optimal approach to evidence-based medicine is the adoption of third-party, peer-reviewed standards that are regularly updated to reflect contemporary medical practice standards.
  3. A drug formulary should not handle new and legacy claims in the same manner. By “legacy claims,” I mean those claims that exist before the formulary rules come into effect. A patient taking his first opioid is different than a patient who has taken opioids for many years. While new claims require primarily process education for the stakeholders, there should be a remediation period for “legacy” claims to allow time for appropriate weaning and development of alternative treatment methods. Based on my observations, there should be a one- to two-year period between the rollout of a drug formulary for new claims vs. “legacy” claims. Both implementation dates should be unchangeably enforced to ensure action is taken. To be clear, any formulary that applies to new claims should also apply to legacy claims, albeit at a later date. Not applying the formulary to legacy claims would result in two different standards of care for injured workers in California depending on when the worker was injured. This is clinically inconsistent with the application of evidence-based medicine.
  4. A drug formulary will change prescribing behavior. The extra steps required for a drug that is not allowed by the formulary requires the prescriber to think through the best options as opposed to just maintaining past practice patterns (however they were developed). For example, if carisoprodol was excluded from the formulary, the prescriber either needs to validate the medical necessity through a preponderance of evidence or choose a muscle relaxant that is included (which likely means it has less dangerous side effects, has proven to be more effective for certain conditions and does not have dangerous drug-to-drug interactions). Given experience in other states, the prescriber will often choose the less dangerous drug included in the formulary, which should result in better clinical outcomes for the patient.
  5. A drug formulary should be enforced at the point-of-sale. Allowing drugs to be given to the patient and THEN deciding whether they are clinically appropriate allows the start of a potentially dangerous path to polypharmacy regimens that create more harm than good. A workers’ compensation drug formulary, just like those we see in group health plans, should be implemented at pharmacies within their point-of-sale system. The information provided to pharmacists will help them better communicate with the patient and prescriber as necessary for an option that is allowed by the drug formulary. One advantage for California is that pharmacy benefit managers (PBMs) and pharmacy chains already have experience with implementing a workers’ compensation formulary in other states. If California is modeled after that same process, there should be less up-front time required to develop processes for California.
  6. A drug formulary should be the result of consensus among all stakeholders. While reaching consensus takes longer, providing a seat at the table for every workers’ compensation stakeholder in a very transparent process will ensure a smoother implementation. It’s extremely important to the ultimate success of a drug formulary that everyone be part of the deliberation process. And if everyone is involved in developing the drug formulary, ultimate implementation will be more easily achieved. A point of clarification: while the process surrounding the drug formulary should be based on stakeholder consensus, the medical treatment guidelines upon which the formulary is built should NOT be based on consensus, but rather on the best contemporary medical evidence available. California stakeholders should focus negotiations on the rules governing the formulary, not on the medical principles that underpin it.
  7. A drug formulary should educate all stakeholders clearly and consistently. Clear (and free) education needs to be provided to all prescribers, all attorneys, all payers, all employers and preferably all injured workers as to how the drug formulary was constructed, how it will be implemented and how best to comply. Preferably, this would be led by the Division of Workers’ Compensation. This education should not stop in the lead-up to implementation but should continue in a feedback loop during and after to ensure that issues are identified and resolved quickly.
  8. A drug formulary should be simplified for ease of implementation. States with workers’ compensation drug formularies have made the choice of drugs relatively binary. For instance, a drug may be classified as one that is recommended for first line therapy (“Y” drug) or a drug that is not recommended as first line therapy (“N” drug) and should not be used unless it has been reviewed and approved by a second clinical opinion. The definition of what is and is not included in the formulary should not be narrative or interpretive, but something easy to read and — more importantly — to program into pharmacy benefit management (PBM), utilization review (UR), independent medical review (IMR) and bill review systems.
  9. Drug formulary rules should include a well-defined dispute resolution process and expedited appeal process. The goal of a closed formulary is to ensure that there are safeguards in place to prevent unnecessary medications from being dispensed to injured workers. The exclusion of a drug from the formulary (for example, an “N” drug) should not mean it cannot be utilized, only that the prescriber should be required to validate its medical necessity vs. drugs that are included. California obviously already has that infrastructure, which is why I felt in 2012 that California was a candidate for a workers’ compensation drug formulary. The onus should be on the prescriber to provide necessary evidence as to why this particular drug is required for this patient at this time. If that can be established, then that drug should be allowed to be given to the patient.

If the above steps are taken and appropriate time is given for their completion, a properly constructed and implemented drug formulary in California should result in cost savings to the system. The primary savings will emerge over time as fewer and fewer of California’s injured workers are lost to dependence, addiction and overdose. The ability to settle and close claims more quickly will be a positive result for both employers and employees.

A workers’ Compensation drug formulary could have a lasting and significant change in how prescription drugs are prescribed in California. I truly believe that by making everyone in the system think before prescribing, the injured workers will receive better care, and stress on the workers’ compensation system in California will be reduced.

I would enjoy being a continued resource to this committee as deliberations evolve. Thank you again for the opportunity to be part of this hearing.

Moneyball and the Art of Workers' Comp Medical Management

Recently, I watched “Moneyball,” the movie, for the third or fourth time. The story is compelling, as is the book by the same name that preceded it.1

“Moneyball” is based on the concept called Sabermetrics, defined as “the search for objective knowledge about baseball.” The central premise of “Moneyball” is that the collective wisdom of baseball insiders, including players, managers, coaches, and scouts over the past century, is subjective and flawed. The book argues that the Oakland Athletics general manager, Billy Beane, took advantage of analytic, evidenced-based measures of player performance to field a team that could compete successfully against far-richer teams in Major League Baseball. During the 2002 season, the Oakland A's won enough games to make the playoffs in spite of a meager salary budget and “inferior” players.

Even though the two industries are diametrically dissimilar, distinct parallels can be drawn between baseball and workers’ compensation medical management.

Similar Resistance to Analytics

One similarity is the resistance to adopting analytics as a knowledge tool. Baseball insiders and managers opposed Beane’s analytics, sometimes vehemently. Long-held beliefs among baseball insiders promoted measures of performance such as stolen bases and batting averages. Beane’s metrics debunked the old methods, revealing unrecognized strengths in lesser-known, more affordable players.

Similarly, workers’ compensation leaders have relied on traditional medical provider networks and personal preferences to select medical doctors. If doctors are in a network and offer a discount on medical services, all is good. Yet, industry research has shown that not all doctors are equal. Doctors and other medical providers who understand and acknowledge the nuances of workers’ compensation drive better outcomes. It’s a matter of finding those doctors.

Finding Best Performers

The purpose of “Moneyball” Sabermetrics is the same as workers’ compensation medical metrics—to find the best performers for the job. The way to do that in baseball is to analyze the data defining actual performance in terms of outcome—games won. In workers’ comp, the data must be scrutinized to find doctors who drive positive claim outcomes. In both cases, a variety of metrics are used to support the most effective decisions.

Performance Indicators

As in baseball, the goal in medical management is to apply objective information to decision-making using evidenced-based measures of performance. For both industries, cost is a factor. However, in workers’ compensation, the cost of medical care must be tempered by other factors:  What is the duration of medical treatment? What is the return-to-work rate associated with individual doctors? What providers are associated with litigated claims?

As in baseball, the list of indicators for performance analysis is long. However, the sources of data differ significantly.

The Data Challenge

In baseball, all the data necessary for analysis is neatly packaged. Statistics are gathered while the game is in progress. In workers’ comp, the data that informs medical management resides in disparate systems and must be gathered and integrated in a logical manner.

Essential data lives in bill review systems, claims adjudication systems and pharmacy (PBM) systems and can also be found in utilization review systems, peer review systems, and medical case management systems. The data must be integrated at the claim level to portray the most comprehensive historic and current status of the claim. Data derived from only one or two sources omits critical factors and can distort the actual status or outcome of the claim.

Once the data has been integrated around individual claims, meaningful analysis can begin. Indicators of performance can be analyzed with new conclusions drawn about the course of treatment and medical provider performance. Moreover, concurrently monitoring the updated claim data leads to appropriate and timely decisions.

Data Positioned as a Work-in-Progress Tool

In baseball, the data is used as a work-in-progress information tool. Decisions about the best use of players are made daily, sometimes hourly. Workers’ compensation medical management can do the same. Systems designed to monitor claim details and progress can alert the appropriate persons when events or conditions portend complexity and cost.

Industry Status

Analytics in baseball is not exclusive to the “Moneyball” Oakland Athletics. All of Major League Baseball now relies heavily on its use. Unfortunately, there are still only a few visionary Billy Beanes in workers’ compensation medical management. Yet, applying analytics for cost and quality control is simple and affordable and can be adopted quickly by all.

1Lewis. M. Moneyball: The Art of Winning an Unfair Game 2003. The film “Moneyball”, starring, Brad Pitt was released in 2011.

How to Tap the Secret Power of ICD-9's

The medical portion of Workers’ Compensation claims now meets or exceeds 60% of claim costs. That fact alone should easily convince payers to focus on the rich medical information in their data. Very powerful information residing in claims data is virtually untouched—diagnostic codes in the form of ICD-9’s. The problem is few in the industry really understand ICD-9’s or in what ways they could inform powerful medical management.

ICD Defined
ICD-9 codes are not unique to Workers’ Compensation. ICD-9’s are the World Health Organization's International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). They are a standardized method of describing injuries, illnesses, and related issues worldwide.

ICD is the classification that codes and classifies mortality data worldwide. The ICD-CM is used to code and classify morbidity data from inpatient and outpatient records and doctor’s offices.

The purpose of the ICD and of WHO (World Health Organization) sponsorship is to promote international comparability in the collection, classification, processing, and presentation of mortality statistics. New revisions of the ICD are implemented periodically so that the classification also reflects advances in medical science.

ICD’s in Standard Billing Forms
Those who bill for medical services in the U.S. are required to use one of two CMS (Center for Medicare and Medicaid) standard forms, the HCFA-1500 (Health Insurance Claim Form) for outpatient and UB-04 Unified Billing) for hospitals and other facilities. Both standardized forms require the medical provider to list ICD-9’s appropriate to the medical procedures for which they are billing. The verdant data derived from these forms should be analyzed and incorporated into managed care processes.

Unwieldy and Ignored
Bill review organizations and payers capture data from the standardized billing forms in their systems. Nevertheless, while the ICD information is documented in systems, it’s use usually stops there. ICD-9’s are difficult to interpret.

ICD-9’s on bills are displayed in the form of codes, not descriptions of injuries and illnesses and they number in the thousands. Individuals cannot remember the codes, nor do they have the time to look up codes for interpretation. Instead, they simply ignore them.

Secret Power of ICD
Incremental essential knowledge resides in ICD-9 codes that can be translated to powerful medical management. When they are monitored electronically and concurrently, they reveal and inform.

ICD-9’s Reveal Migrating Claims
For instance, migrating claims accrue ICD’s. Migrating claims are those that are not going well, are becoming more complex and costly, often an insidious process that is missed by claims adjusters and medical case managers until considerable damage is done. What happens in migrating claims is the injured worker is not recovering for some reason and is referred to multiple specialists. Each specialist adds new ICD-9’s to the claim.

As a claims migrates, the number of ICD-9’s associated with it mounts.

Computer Monitoring
Using a computerized system especially designed to monitor ICD-9’s is a powerful knowledge solution. Alerts are sent to appropriate persons when the number of ICD-9’s in a claim increases beyond a designated point. Migrating claims cannot be missed and intervention is early, therefore far more effective.

ICD-9’s are Predictors
Another way to tap the secret power of ICD-9’s is to score them individually for medical severity, the seriousness of the injury or illness. Each claim then contains a total ICD-9 score in the system for medical severity. As ICD-9’s are added during the course of the claim, the claim ICD score increases. As a claim migrates and accumulates ICD-9’s, an appropriate person is automatically notified by the system. Migrating claims cannot go unnoticed.

Claims with high ICD-9 scores are predictors of risk and cost. Claim ICD-9 scores can be monitored from the outset and throughout the course of the claim.

ICD-9’s Scores Level the Playing Field
The claim ICD-9 score reveals the seriousness and complexity of a claim. Medical doctors managing difficult claims can be differentiated from those handling less arduous claims, thereby creating fairness in measuring provider performance.

Many indicators are used for claim monitoring and provider performance including medical cost, frequency and duration of treatment, indemnity costs, return to work and multiple other factors. The claim ICD medical severity score automatically predicts trouble and alerts the appropriate medical managers.

Moving on—ICD-10
The ICD-9 contains thousands of codes. Moreover, the ICD-10 revision will more than double the number of codes, making its information value exponential. ICD-10 is slated to be activated in October of 2014.

SB 863 Update: Is the California Workers’ Compensation System Better Than it Was One Year Ago?

The passage of SB 863 in California came with a promise of higher benefits for injured workers and lower costs for employers.  Just over one year later, where does this promise stand?There has been improvement, but there is still a long way to go.

I recently attended and spoke at the California Workers’ Compensation & Risk Conference in Dana Point, California, where, as expected, the major focus was SB 863.  Just over one year ago, employers and labor came together at the end of the legislative term to pass a bill designed to improve benefits for workers and reduce costs for employers.

I moderated the opening session, which was a diverse panel featuring representatives from employers, carriers, injured workers, and medical providers. My first question to the panel set the tone for the rest of the session, and for the rest of the conference. That question was: “From your viewpoint, is the California workers’ compensation system better off now than it was a year ago?”

Before you can gauge the success of SB 863, you must remember where we started.  Permanent disability (PD) benefits to injured workers had been cut significantly under prior reforms, so injured workers were unhappy with the system. Employers were equally unhappy, as workers’ compensation costs in California had been increasing steadily for years.

With a system that both injured workers and employers were very dissatisfied with, something had to be done.

SB 863 provided an immediate increase in permanent disability benefits for accidents occurring after 10/10/2013.  PD is being increased by a total of 30%, phased in over two years. There is also a $120 million fund to compensate certain workers who are unable to return to their pre-injury job because of physical restrictions.

The savings for employers are to come over time.  The largest of the savings under SB 863 are to come from changing the processes for liens and medical disputes. Thus far, these changes are receiving mixed reviews.

On the plus side, liens have fallen significantly since a fee for filing them was implemented Jan. 1. Some of the drop can be attributed to the fact that medical providers filed all the liens they could before the fee took effect. However, there clearly has been a significant drop in new liens filed.

The filing fee is being challenged, though, by a lawsuit that seeks to have it declared unconstitutional, and some of the anticipated savings from SB 863 are likely to be eroded if the courts don’t uphold the fee.

The bill also restructured the medical dispute resolution process, with the introduction of the Independent Medical Review (IMR). The IMR process was modeled after successful programs in states such as Texas. It is designed to have physicians, not judges, deciding disputed medical issues. It is also designed to expedite resolution so appropriate treatment is provided to injured workers in a timely manner. The IMR process clearly remains a work in progress. First, 10 months after implementation, the process is still operating under emergency rules. Until the final rules are in place, those participating in the process will face uncertainty. Second, it appears there is significant gaming of the IMR process. Approximately 16,000 requests were filed in both August and September of this year alone, significantly more than anticipated.  In one month, there were more disputes filed than in an entire year for the same process under group health.  Employers alone bear the costs of the IMR process, so those filing all these requests may be attempting to cripple the system at absolutely no cost to themselves.

The issues facing the IMR and lien processes illustrate what many see as the major impediment to delivering cost savings for employers in California: There are special interest groups that do not want the system to become more efficient and self-executing, because they make a great deal of money off the chaos.

In her speech at the conference, Christine Baker, director of the California Department of Industrial Relations, expressed concern about “significant gaming.” While this gaming is not unique to California, from my national viewpoint its impact on the workers’ compensation system is more profound in California than in other states.

The biggest challenge is that the workers’ comp system in California is flawed by design. No other state has issues with medical liens in workers’ compensation. Bills are reduced to fee schedule with no further disputes seeking additional payment. Treatment that is not authorized is subject to litigation over necessity. If the employer prevails, “no” means “no.”  In California, “no” means “file a lien and litigate further.”

Another issue facing California employers is continuous trauma (CT) claims, which can be filed for a 1% aggravation of a pre-existing condition. The legislature recently fixed this problem for the National Football League by passing a bill specifically limiting CT claims by professional athletes, but CT claims in California continue to be a significant cost driver for other employers, and their frequency has more than doubled over the last 10 years.  It is common in California for injured workers to file both CT and specific injury claims for the same body part.  In no other state are CT claims as prevalent and embedded into the workers’ compensation system as they are in California.

In addition, allocated loss adjustment expenses (ALAE) covering items such as bill review, utilization review, and litigation costs are higher in California than other states, and these costs are increasing at an alarming rate.

The gaming of the system significantly increases the costs for employers and delays the delivery of benefits to injured workers.  The main stakeholders in workers’ compensation, the employers and workers, need to work together so that benefits can be delivered faster and at lower cost.  SB 863 was a step in this direction, but there is more work to be done. The people who worked together to make SB 863 a reality need to continue to work together to preserve the savings elements designed into the bill.  If they can do this, perhaps California can finally achieve some stability in its workers’ compensation marketplace, which would benefit both employers and injured workers.

Workers' Compensation—What the Numbers Say

Even though people talk a lot about the value of analytics for workers’ compensation, few have actually implemented them in ways that provide their full value.

To improve, insurers should draw on lessons from, of all things, supermarkets. Supermarkets and grocery stores have long automatically documented transactions at the register. When those transactions are analyzed in context with other data, such as inventory turns and factors such as season and weather, conclusions can be drawn about how buying behavior, and predictions can be made. Operational decisions spring from the analytics, such as diverting high-demand inventory to regions that are projected to need it. The result is increased sales and satisfied customers.

Like the supermarket industry, the workers’ compensation industry collects data continually. Bill review systems document medical bills received and recommend payment based on data analysis. Claims systems document medical bills paid, indemnity paid, work loss, legal actions and other factors, all related to the claim. Still more data is collected related to pharmacy, utilization review and other issues.

But, amazingly, the rich data is rarely converted to operational tools like those that drive supermarkets. Most in workers’ compensation neglect to use their data to identify opportunities to mobilize action early and limit, or even thwart, potentially high risk and costly situations.

As with supermarkets that anticipate demand, insurers should analyze all available data in real time, and alerts about workers’ compensation should be sent to appropriate persons to give them the jump on problems. Adjusters and nurse case managers should receive specific information regarding new conditions so they can mobilize action—when a known, high-risk condition occurs in a claim, that information should be automatically transmitted to an appropriate person. A simple example is when multiple prescriptions of opioids are found; a nurse case manager should be electronically notified and take action. 

Besides saving money, analytics can allow for a formal infrastructure for medical management, optimizing efficiency.

So, as unlikely a model as supermarkets might appear to be, workers’ compensation companies should learn a lot from them.