New York Workers' Compensation Drug Formulary
Walk us through what to anticipate for the 12/5/19 effective date?
Effective December 5, 2019, all new prescriptions are required to conform with the New York Workers' Compensation Drug Formulary (Drug Formulary). If a prescriber wishes to utilize a non-formulary drug, prior authorization approval must be obtained before prescribing or dispensing the non-formulary medication.
In terms of length of therapy or dosage, what constitutes an adequate trial for failure of a first-line agent before a "2nd" drug is authorized?
Although there is no required duration of use for a "Yes" drug, a "2nd" drug would be deemed appropriate if the "Yes" drug has been tried by the injured worker and discontinued due to provider documented:
- lack of efficacy or effectiveness, or
- diminished effectiveness, and /or an
- adverse event, or
- Would be considered contraindicated because of the injured worker's comorbid condition(s).
According to the Board, "One medical provider group expressed concern that the regulations do not incorporate "step therapy protocols" as set forth in the Insurance Law and Public Health Law. Step therapy protocols are not applicable to Workers' Compensation Insurance. Accordingly, no changes have been made to the revised proposed regulations as a result of this comment." Is step therapy required to account for the "2nd" drugs?
To use a "2nd" drug, there needs to have been an unsuccessful trial of a "yes" drug as described within the applicable adopted Medical Treatment Guideline.
For "2nd" line step therapy, how do we know what applicable first-line agents are if the ACOEM guidelines say: "First line therapy includes NSAIDs…." All NSAIDs? All formulations?
First line agents are identified in the adopted New York Workers' Compensation Medical Treatment Guidelines (NY WC MTG). Items within the identified therapeutic categories (i.e., NSAIDs) are delineated on the Drug Formulary.
What does it mean if a medication is marked as a Phase B drug = X but there is no "Yes" or "2nd" listed under any of the NY WC MTG? Are these medications non-formulary drugs? If so, why is there an X in the Phase B column? For example, Antacids.
The Board, via emergency regulation, will be releasing a modified version of the Drug Formulary that will contain Special Consideration #4: "As clinically indicated for causally related injuries or conditions utilizing accepted standards of medical care." Meaning that the item on the Drug Formulary can be prescribed and dispensed:
- When there is no adopted Medical Treatment Guideline for the established/accepted body part or condition, and/or
- For a condition directly associated with an established/accepted body part, but not specifically addressed in the NY WC MTG.
- An example would be the treatment of a post-operative infection following a knee replacement.
What happens when the scripting providers are out of state?
Out of state providers need to comply with the Drug Formulary and will have access to the Drug Formulary Prior Authorization System to submit requests for non-formulary medications.
How many periods of 90 days can the drug be prescribed? Should there be an interval?
Phase B Drug Formulary medications can be prescribed for up to a 90-day supply. There is no limit to the number of repeat 90-day supplies that a prescriber may order.
Please clarify the Drug Formulary regarding short and long-acting opioids and the Special Considerations.
Special Consideration 3 states that only the short-acting form of the medication is considered Drug Formulary. Therefore, if a long-acting form is desired a non-formulary request must be submitted and approved before the medication can be dispensed.
Does a non-NY WC MTG body part require prior authorization for non-formulary?
All non-formulary medications must be approved by a prior authorization request before they can be prescribed and dispensed. Special Consideration 4 has been added to address the use of medication in non-MTG body parts.
Specifically, Special Consideration 4 indicates "As clinically indicated for causally related injuries or conditions utilizing accepted standards of medical care". Meaning the item on the Drug Formulary can be prescribed and dispensed:
- When there is no adopted MTG for the established / accepted body part or condition, and/or
- For a condition directly associated with an established/accepted body part, but not specifically addressed in the MTG.
Is there any functionality in the Portal to verify that the requested drug requires prior authorization?
The Portal does not currently have the capacity to verify whether a drug that is requested requires prior authorization. The drug not needing prior authorization should not be utilized as a reason to deny the prior authorization request.
What happens when the Pharmacy Benefits Manager gets a request for a drug that requires prior authorization from the pharmacy before the physician has completed and transmitted the prior authorization request in the Portal?
If a prescription is received for a drug requiring prior authorization, and no prior authorization request has been submitted/approved, the patient should be referred to the physician.
Does the prior authorization request state the reason that the medication requires prior authorization?
The prescriber is required to submit justification/rationale for the non-formulary drug requested. This can be in the form of either free text, or attachment of documentation to the prior authorization form.
Is an approval of a medication request for authorization considered a waiver for future prescriptions of the same drug?
Prior approval requests must include a duration of therapy; this can be up to 365 days. At the end of the approved time period, a new prior authorization request would need to be submitted and approved. If a different non-formulary medication is requested, or the same medication for a different dosage, a new prior authorization must be submitted and approved prior to dispensing of the prescription.
Can a payer have more than one designated reviewer on a specific prior authorization request?
The Board encourages multiple reviewers at each level.
Can payers approve prior authorizations orally, or only in writing via the prior authorization procedure?
All responses, whether approved, partially approved or denied, should be submitted through the prior authorization process via the Medical Portal.
Can multiple medications be requested on one prior authorization request?
How long does the Board have to make a determination for a Level III requests?
The regulations do not dictate the time frame for Level III determinations. However, the Board expects this will be three to five days.
Does a payer have to use the new Drug Formulary as is, or can they add additional prior authorization requests?
Carriers, Self-insureds and provider must adhere to the Drug Formulary and prior authorization process as prescribed by the Chair of the Workers' Compensation Board
Will the prior authorization indicate how the requested drug falls outside of the Drug Formulary?
When submitting a prior authorization request, the prescriber must provide rationale for requesting the non-formulary medication.
If a Level I prior authorization takes a few days to complete, who is responsible for informing the injured worker of the decision?
The prescriber is responsible for communicating medication status to the patient.
Is there an expected percentage of instances that an Order of the Chair approval will be issued for a prior authorization review response not given after four calendar days? Will this occur effectively every single time?
It should be expected that if the Level I or Level II requests are not responded to in the allocated time frame, that an Order of the Chair will be issued.
Should carriers process prior authorization requests for continuation/refill of medications submitted prior to June 5, 2020?
Yes. All prior authorization requests submitted via the Medical Portal (whether for new or continuation/refills) should be process and reviewed.
Although refills/renewals of medications are not required to comply with the New York Workers' Compensation Drug Formulary (Drug Formulary) until June 5, 2020, if a prescriber submits a request via the Medical Portal, the carrier must process and review the request.
How should a prior authorization request for a refill/renewal of a non-formulary medication be processed by the carrier that is submitted prior to June 5, 2020?
If the prior authorization request provides appropriate clinical rationale/justification that would justify the use of the non-formulary medication, it may be approved for up to a one-year supply. Said differently, if you were reviewing this on June 5, 2020, and would approve it, then approve it now for up to one year.
If the prior authorization request does not provide appropriate clinical rationale/justification for use of the non-formulary medication, then an approval (for up to a 30-day supply of the medication) should be granted. The reviewer should indicate that it is being approved as a refill/renewal for no more than a 30-day supply in anticipation that a subsequent request will be submitted with appropriate documentation to fully support the use of the non-formulary medication.
While a variance is not necessary for a refill/continuation of a medication, if an Attending Doctor's Request for Approval of Variance and Carrier's Response (Form MG-2) for a refill/continuation is submitted, the carrier should process the request using the current procedures until June 5, 2020, at which time all requests must go through the Medical Portal Prior Authorization process. Please be reminded that all requests for new medications must go through the Medical Portal Prior Authorization System effective December 5, 2019.
If a provider submits a prior authorization request for a renewal or refill of a non-formulary drug prior to the 6/5/20 effective date, what will be the process for the Level I reviewer to indicate in the Medical Portal that the request does not yet require prior authorization?
Prescribers may utilize the electronic prior authorization process for requesting non-formulary drugs any time after the electronic process is released for general use. Prescribers are actively encouraged to submit prior authorization requests well in advance of the June 5, 2020, deadline for Drug Formulary compliance of refills. This will help insure that injured workers have the medications they need.
How long does the prior authorization request stay on the Dashboard after a determination is entered?
At this point requests will stay on the dashboard indefinitely. The Board is currently exploring options for archiving fully completed requests, recognizing that there may be a need for all users to access older requests.
If prior authorization request for a medication is denied, will the provider ever be able to ask for a prior authorization for it again, say a month or a year later?
If a request is denied, a substantially similar request should only be submitted with additional appropriate supporting clinical documentation and rationale.
If the prescriber does not use the Portal, and the injured worker takes a prescription directly to the pharmacy, would the prescription not be approved until the provider does so?
If an injured worker presents at the pharmacy with a prescription for a non-formulary drug for which a prior authorization request has not been approved, the pharmacy may either (a) reach out to the prescriber and inform them that a prior authorization request must be submitted and approved before the medication can be dispensed or (b) refer the injured worker back to their provider.
Is there a requirement for the provider to submit clinical documentation to support the request for non-formulary medication? Or is the free text box explanation considered sufficient by the State?
Justification/rationale for the use of a non-formulary medication must be submitted as part of the prior authorization request. This can be either free text entered onto the prior authorization form and/or attachments to the request form.
Is it four business days, or four calendar days to respond?
The prior authorization process utilizes a 96-hour clock for purposes of calculation. Actual calendar days are not counted. The 96-hour clock will continue to tick during weekends and holidays.
If a request is reassigned to a different entity, does it restart the clock on the four days? For example, if the physician sent the request to the wrong Level I reviewer.
The prescriber does not select the reviewer. The request is automatically routed based on the information the insurer has entered into the system. The clock starts when the prescriber submits the request.
Is there a way to identify a covering adjuster when out of the office, to meet the four-day deadline?
The workload administrator is responsible for assigning (or reassigning) reviews. The Board recommends that an entity identify multiple workload administrators and multiple reviewers.
How long does the Medical Director's Office have to respond to the request?
The regulation does not specifically address the turnaround time for the Level III review. However, it is expected that there will be a three to five-day turnaround on Level III reviews.
I am a utilization review (UR) organization agent. This process does not seem to involve UR. Is that correct? This process is reviewed by the Payer (Workers' Compensation Insurance) or the Pharmacy Benefit Manager?
The insurer may identify their choice of entities to perform the Level I reviews. Level II reviews are restricted to the carrier's physician. The carrier's physician means a physician or physicians, licensed by New York State, or the appropriate state where the physician practices who is:
- Employed or contracted by the insurance carrier or self-insured employer; or
- Employed by a URAC accredited company retained by the insurance carrier or self-insured employer through a contract to review claims requests for non-formulary agents and advise the insurance carrier or self-insured employer; and
- Not employed or contracted by the carrier or self-insured employer's pharmacy benefits network.
If a carrier is going to use a URAC accredited company for Level II reviews, approval is needed from the Chair of the Worker's Compensation Board prior to utilizing the review organization. Such approval should be requested in writing to:
NYS Workers' Compensation Board
328 State Street, Schenectady, NY 12305
If the UR sends the request to be reviewed and the peer responds – the UR nurse cannot enter the information? The peer enters this information into the Portal?
The individual who is performing the review will need to log into the Medical Portal, access the dashboard, select the item to review and enter the decision directly into the designated section of the prior authorization request form.
Where do utilization review organizations (and their second-level reviewers) fit into this flow and registration?
Carriers and self-insured employers are responsible for designating their Level I and Level II reviewers. The Level II review must be conducted by the carrier's physician, there are no specific requirements for who may perform the Level I reviews.
What qualifications must the Level I reviewer meet, if any? Are clinicians required for Level I review? Are nurses or pharmacists allowed to make Level I review?
No specific qualifications are included in the regulation. However, the reviewer must be able to directly respond to the prescriber's submitted rationale for the request for the non-formulary medication.
Can a person be registered as a workload administrator and a reviewer?
Will the reviewer get email notification of the item in their dashboard, such as if the workload administrator reassigns to a specific reviewer?
The workload administrator will get an email notification that an item has been submitted to their dashboard (and needs to be assigned to a reviewer). All other notifications will be made via the users Dashboard.
Does the Level II decision require that a rationale be returned with it?
All reviews need to directly respond to the rationale submitted by the prescriber for the request.
Will the reviewer (third-party) be able to see the former decisions?
Although the Board is developing an archiving process for completed reviews, at this point completed reviews will remain on the Work Load Administrator's dashboard indefinitely.
Is a Level I user able to reassign to another Level I user? Or does that need to be done by the payer administrator?
Only the workload administrator can assign/reassign reviews. However, an individual can be both a workload administrator and a reviewer.
I have heard that Level II reviewers must be individually registered in the Portal. Is this true? Is the URAC-accredited entity able to assign the specific reviewer for each case and enter the reviewer's decision into the portal?
The prior authorization application is housed within the Medical Portal. Therefore, all users of the prior authorization application need to be registered to access the medical portal. Each level of review will have a designated workload administrator who is responsible for assigning reviews to individual reviewers. Given the authentication that's is required to access the prior authorization system within the Medical Portal; individual reviewers are expected to enter their own decisions.
For a Level I review, you mentioned that we need to respond to the rationale the doctor provided. Does the response need to be from a medical professional at this Level I review?
Reviews and associated responses should be completed by individuals competent to respond to the information provided by the prescriber.
If there are multiple Pharmacy Benefit Managers per insurer, will the insurer or their Third-Party Administrator then need to manage the individual users, rather than the Pharmacy Benefit Managers given the functionality?
Yes. If a payer has multiple Pharmacy Benefit Managers per insurer (W number), the insurer must manage the Pharmacy Benefit Manager users in their organizational profile. The payer's workload administrator must assign the requests in their dashboard to the correct users accordingly.
Does a payer need to enter users for Level I if they are using a Pharmacy Benefit Manager for Level I reviews?
All reviewers must be entered into the Drug Formulary administration system. Drug Formulary Administration
Can the Pharmacy Benefits Manager choice by payer be confirmed on the website by the Pharmacy Benefit before the choice is reflected?
The Pharmacy Benefits Manager must be registered in the system before they can be selected as a reviewer.
Must Pharmacy Benefit Managers still register, if they are assisting only one single payer? Pharmacy Benefits Managers can't differentiate what payers they are assisting.
A Pharmacy Benefits Manager can be assigned as a reviewer for one or multiple payers.
If a Pharmacy Benefits Manager is not doing the Level I review, do they still need to register as a Pharmacy Benefits Manager?
Only reviewers need to register for the prior authorization system.
Can you confirm that the physician must be the payer's physician (medical director) and not the Pharmacy Benefits Manager's physician?
Please see Subchapter M of Chapter V of Title 12 of NYCCR Part 441.1(g) for the definition of "Carrier's Physician".
If an employer is self-insured, will they need to register the contact for their Pharmacy Benefits Manager?
All users of the prior authorization system must be registered.
Is it required that the Pharmacy Benefits Manager be designated by the payer?
Both Level I and Level II reviewers must be designated by the payer.
Is a Third-Party Administrator with multiple carriers, able to assign different reviewers for each unique carrier?
Can a Third-Party Administrator be designated as Pharmacy Benefits Manager?
There is no requirement for the designation of a Pharmacy Benefits Manager; only Level I and Level II reviewers need to be designated.
Prior to the launch date, will there be an opportunity for us to work with the Portal to further understand how it works?
A test environment of the Medical Portal and the prior authorization system is not available for users.
When will the Portal access be granted?
Information about signing up for the Medical Portal can be found at the Medical Portal page.
Can there be more than one user administrator per insurer and more than one workload administrator?
Yes, the Board encourages multiple users in each of these roles.
What happens when a claimant has several claims, and the provider submits the prior authorization request on the incorrect claim?
A prior authorization request submitted on a wrong claim may be denied by the carrier.
Is the NY WC MTG information that is now searchable in the Portal able to cut/paste into the Portal where a Level I review decision is submitted?
The MTGs will continue to be posted as PDF files and can be utilized as such.
When will the communication templates (for injured workers and providers) be available?
Subject Number 046-1198, released August 13, 2019 contained the templates required for communication with prescribers and injured workers.
When do you anticipate/expect to have the Treatment Lookup Tool and/or the Drug Formulary Lookup Tool implemented and ready to use?
The Drug Formulary lookup tool will be available upon implementation of the prior authorization system. The MTG lookup tool will be released early 2020.
When would a provider submit Form MG-2 for medication vs using the Portal, or should all requests go through the Portal?
Upon the release of the prior authorization system, all requests for non-formulary medications must be submitted through the prior authorization system. Only requests for medical marijuana should continue to go through the current MG-2 process.
Are the NY WC MTG going to be updated? Or we are still using 2014 version?
MTGs are reviewed on an ongoing basis. Currently adopted versions of the MTGs are posted on the Board's website and should continue to be used.
If a claim is apportioned between two different carriers, will both carriers get the request?
No. The primary insurer will receive the request.