FORMULARIES CAN HELP ADDRESS LIFE THREATENING ISSUES
There is a consensus among Stakeholders that action needs to be taken to protect the well-being of Louisianans against the life threatening prescription drug crisis confirmed by the Workers Compensation Research Institute (WCRI), the Centers for Disease Control (CDC) and other respected sources. Louisiana has experienced record overprescribing in workers’ compensation, along with prescription related overdoses and deaths. It is therefore frustrating that a second or third year may pass with more lives being destroyed as stakeholders consider the options. It appeared that Stakeholders were on the road to agreeable legislative/regulatory language in 2015, and with appropriate modifications and provisions for development of regulations reflecting negotiated stakeholder positions, HB725 could be a vehicle to help address the crisis.
If Texas experienced improved patient outcomes with an over 60% decrease in prescribing of opioids and a decrease in over 80% in spending since the adoption of the ODG Formulary, Louisiana should be capable of significantly improved patient outcomes as well. The ODG Formulary will most significantly impact post adoption claims with associated changes in prescribing patterns, resulting in less drug dependency and less over prescribing. Formularies and their supporting guidelines further insure proper access to drug tapering and weaning programs as necessary, along with any other medically indicated restorative or maintenance care for the accepted condition.
In a group health scenario, formularies are a list of covered drugs and the associated pricing tiers. In workers’ compensation, injured workers are entitled to any drug that can be medically substantiated and causally related to the accepted condition(s) regardless of cost. The formulary is simply a means of bucketing prescriptions into levels of review for authorization (fast track versus needing detailed medical substantiation) to safeguard injured workers against higher risk or unnecessary medications. This affords all injured workers equal access to medications regardless of employer, insurer or pharmacy benefit managers (PBM). Delivery of lower risk medications is expedited while decreasing costly layers of processing and review.
A formulary affords safeguards in both employee or employer “choice of pharmacy” scenarios, with consistent formulary standards for all injured workers, improved outcomes, decreased prescribing of higher risk drugs and lower overall pharmacy spends.
EVIDENCE & CONDITION BASED FORMULARIES
Formularies and the supporting evidence-based guidelines afford decision makers access to the evidence-based medicine (EBM) to support fair and equal decision making for all injured workers while allowing for case specific scenarios.
Most PBM, Payer and UR systems have already successfully integrated the ODG Formulary (database over 33,000 lines with access to condition-specific guidelines) into their systems and processes with improved clinical outcomes. Physician, Pharmacy, PBM, Payer and UR systems offer varying degrees of automation and non-automated clinical decision making and support. These processes are largely dictated by state and policy specific laws, regulations, company policy and procedure, as well as employer and insurer specific prescription handling protocols.
It is imperative to recognize that an effective independent objective publisher of evidence-based medical treatment guidelines:
- Does not author or write the evidence;
- Amalgamates the extensive body of available evidence into a database;
- Objectively and transparently ranks the evidence; and
- Presents the evidence with summaries and electronic tools to support effective claims management for all stakeholders.
The ODG Formulary Table is based on the EBM and references cited in the condition-specific ODG Treatment guidelines. The extended list of treatment options are so displayed to stimulate consideration of the options, such as restorative or alleviating treatment versus prolonged care with addictive debilitating opioids and narcotics. This speaks against references to the Texas and ODG Formulary as a binary or flat system. The ODG Formulary tables, lookup tools and associated links are merely “search tools” to afford easy access to the evidence-based citations, studies and recommendations in the condition-specific evidence based guidelines text.
REALITIES VERSUS PERCEPTIONS
Unfortunately, many who object to workers’ compensation formularies have never physically viewed one and/or the associated supporting guideline. Further, most objectors have not reviewed the current, versus the possible, medication-related processes under an adopted formulary (meeting the Louisiana Guidelines criteria by statute) from the point of a patient-physician encounter, while also taking into consideration the treatment options through the prescribing, initial fill, refill, authorization/denial process, clinical review, UR, appeal, dispute resolution and payment processes for PBM and non-PBM dispensing. Experiencing the reality of a successful evidenced-based formulary program may afford insights into the benefits for all, and would likely dispel subjective perceptions and concerns. It is highly recommended that reviewers apply the formularies to real world, case-specific scenarios, simple and complex, as an insightful “test drive.”
Incorrect assertions have been made that ODG is “binary,” offering only Yes and No options to prescribing, which are not condition specific. On the contrary, the ODG Formulary Table is a look-up tool, linked directly to the supporting evidence, and it encourages consideration of optimal treatment options for the individual patient and causally related conditions.
Joe Paduda (a highly respected industry thought leader, principal of Health Strategy Associates and the founder and president of CompPharma – “a consortium of PBMs that identifies and prioritizes industry-wide problems and then develops and delivers solutions”) and other supporters of medically evidence-based, condition-driven formularies have presented on the topic in Louisiana and elsewhere. Many have been incorrectly led to believe that ODG does not meet these criteria or embrace this approach, but that the Reed/ACOEM Formulary, which has not been adopted in any jurisdiction, does.
Requiring a diagnosis at the time of prescription fill would clearly be a departure from the standard operating procedures in place throughout this country and would significantly negatively impact an injured workers access to prescription medications. It is important to recognize that:
- Diagnoses are not provided to pharmacists on prescriptions, nor are they required to be disclosed to pharmacists;
- PMB’s do not often have the original and/or updated accepted diagnosis or condition;
- Diagnoses and conditions change regularly through the course of a claim;
- All claims are not managed by PBM’s;
- Retail pharmacists or pharmacy techs cannot likely be mandated to validate associations between diagnoses and prescriptions under State Scope of Practice statutes and regulations.
STATUS & RECOMMENDATION CODES
Where ODG uses “Y” and “N” in the Formulary tables, Reed/ACOEM uses “Recommended,” “Not Recommended” and “No Recommendation.” Although these may both appear on the surface to be “binary” or “pick an option,” in the real world handling of claims they are not intended for flat decisions without clinical review. The fact remains that time sensitive and ideally immediate decisions need to be made to authorize, request substantiation or deny. These “Y,” “N,” “Recommended,” “Not Recommended” and “No Recommendation” terms are intended to be used in the pharmacy review process to route the approval of the prescription for case-specific deeper decisions as needed to factor in the injured workers’ scenario. Clinical review (real time, retrospective and/or prospective) of case-specific factors generally includes review of accepted conditions and diagnoses, poly-pharmacy interactions, confounding factors and unrelated medical factors.
Regardless of a ranking of “Y,” “N,” “Recommended,” “Not Recommended” or “No Recommendation,” and regardless of the use of a mandated formulary adoption, a medication must be medically necessary and causally related to be covered by workers’ compensation in most jurisdictions. In ODG, the “Y” designation indicates the drug is indicated as a first line treatment option without submission of detailed substantiation of medical necessity prior to authorization. The “N” designation in ODG indicates that there is a further, “Need for Medical Substantiation,” as a safeguard for the injured worker due to the associated risks of a drug on a stand-alone basis and/or in comparison to other evidence based alternatives. This flags “N” drugs for review of risks and/or medical substantiation prior to authorization of first or subsequent medication fills, thereby significantly decreasing overprescribing, abuse, overdoses and deaths from medications which are not medically substantiated. Review can be achieved in real time or within a short period of time stipulated by regulation and subject to rules for emergent, urgent, in-patient and ambulatory surgical center care. How a Reed/ACOEM “No Recommendation” would be handled when a decision must be made to cover, authorize, request additional substation or deny requests for authorization or payment is unknown to us at this time.
CITATION AND RANKING OF EVIDENCE
Both ODG and ACOEM cite and include high ranking evidence in condition-based guidelines sections/chapters.
ODG cites and transparently ranks the relevant available evidence, including low ranking quality of evidence. All ODG chapters are updated annually, with more frequent updates as needed to reflect growing bodies of evidence. Noting that an EBM guideline publisher amalgamates, rather than authors, the objective evidence, providing access to available evidence which may be low ranking is better than not citing any evidence.
It is our understanding that Reed/ACOEM Guidelines indicate “No Recommendation” or “Insufficient Evidence” when high ranking evidence is not available.
STATE ADOPTIONS & INTEGRATIONS
If a key factor under consideration is ODG versus Reed/ACOEM, it must be pointed out that ODG is the only commercially produced evidence-based formulary that has been formally and specifically adopted by statute and/or regulation in any jurisdiction for workers’ compensation in the United States as of April 2016. There are independent statistical and real world documented outcomes and projections of outcomes with ODG adoptions.
Most PBM, Payer and UR systems have already successfully integrated the ODG Formulary with access to the supporting evidence-based ODG guidelines into their systems and procedures.
The ODG Formulary has been formally adopted in Texas, Oklahoma, Tennessee and Arizona. ODG Formulary tables and updates are provided to adopting jurisdictions at no cost or charge for posting on the state agency websites and for unlimited use by regulators and stakeholders.
Jurisdictional adoptions (by statute or regulation) of the ODG Treatment guidelines and/or ODG Drug Formulary in the United States as of April 2016 include Arizona, California, Kansas, New Mexico, North Dakota, Ohio, Oklahoma, Tennessee and Texas. ODG is referenced and/or permitted by statute or regulation in multiple additional jurisdictions including Louisiana, Florida, New York and many others. ODG is commonly utilized by Louisiana Stakeholders to supplement the current Louisiana Workers’ Compensation Treatment Guidelines, as permitted by statute/regulations.
Additional jurisdictional adoptions (by statute or regulation) of the ODG Treatment guidelines and/or ODG Drug Formulary in the United States as of March 2016 are proposed, under review and/or consideration in jurisdictions including but not limited to Alaska, Georgia, Louisiana, Maine, Michigan, Montana, Nebraska, North Carolina, New York, Oregon, Pennsylvania, South Carolina and others.
The ACOEM Practice Guidelines sections were adopted in California (outdated sections dating back six to over ten years) as part of the Medical Treatment Utilization Schedule (MTUS), as were older and more recently updated ODG sections. Both ODG and ACOEM are deemed applicable by the California DWC under the 2015 Strength of Evidence Rules along with MTUS. The only other current state adoption of the ACOEM Guidelines is in Nevada, which adopted guidelines in the late 1990s. Application of the guidelines is not required in Nevada for authorization of care or permitted to be used for denial of care.
ACOEM Practice Guidelines content previously included in the New York Workers’ Compensation Treatment Guidelines has been removed, modified or significantly edited by the NY Workers’ Compensation Board and is not is sync with or supported by the current Reed/ACOEM Guidelines.
Approximately six years ago, ACOEM licensed a now outdated version of the ACOEM Practice Guidelines content to Montana Department of Labor & Industry to be blended with a now outdated version of the Colorado Guidelines to create a new treatment guideline now known as the Montana Utilization & Treatment Guidelines. This new Montana Utilization & Treatment Guidelines is periodically updated and edited by the Montana Department of Labor & Industry.
The ODG guidelines and associated ODG Formulary are published by Work Loss Data Institute (WLDI), an independent privately held company with over 20 years in the guidelines publishing business. WLDI and ODG ownership is independent of any insurance companies, case management or service providers, device or pharmaceutical manufacturers, special interests and/or medical specialty societies.
Multi-disciplinary, independent ODG editorial review boards are convened representing all specialties treating or evaluating specific conditions and body parts under review. Reviewers and are shielded from producers of evidence, citations, studies and reports, as well as special interests and outside influences. WLDI/ODG accepts and encourages open submissions of qualifying evidence for review and consideration.
The Reed/ACOEM Treatment Guidelines and Drug Formulary are the solely owned intellectual property of Reed Group, whose parent company is Guardian Life, an Insurance Carrier. The Reed/ACOEM Drug Formulary has yet to be mandated or specifically adopted in any jurisdiction in the United States. The earlier Beta Version of the Reed/ACOEM Drug Formulary was briefly introduced and withdrawn from the market in 2015.
STAKEHOLDERS & CompPharma
It is noteworthy that regional and national stakeholders doing business in Louisiana, as well as members of CompPharma, including Helios (the largest Workers Compensation PBM) and Coventry/First Script, are ODG users and have publically voiced positive experiences and improved outcomes with the ODG Formulary and Guidelines. Additional CompPharma PBM members are Express Scripts, Mitchell Pharmacy Solutions, My Matrix, and Optium (owners of Helios, CatamaranRX & HealthCare Solutions). These and other industry stakeholders specifically involved with drug formularies can provide testimony on the successes of ODG in other jurisdictions and will further support an ODG Formulary in Louisiana.