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New York Workers’ Compensation Board Releases New Draft Formulary Rules

—October 18, 2018
New York Workers’ Compensation Board Releases New Draft Formulary Rules

By Brian Allen, VP of Government Affairs

On October 17, 2018, the New York Workers’ Compensation Board (WCB) released a revised version of their drug formulary rule. The initial draft was released for public comment last December and the WCB has been evaluating comments and making adjustments since then. The release of this rule has been highly anticipated.  

The revised rule is significantly different from the initially proposed draft and, if adopted, would make New York unique in its approach to a workers’ compensation drug formulary. The proposed formulary is much more complex than those seen in other states. There is, therefore, some concern that the complexity could lead to confusion and defeat the WCB’s original rule update purpose. Despite the complexity, there are some positive provisions in the revised draft.

 

The following is a summary of the proposed drug formulary rule:

Under the definition of non-formulary drug, the rule clarifies that medical marijuana is not addressed under the formulary but will continue to be regulated under section 324.3.

Phases

The drug formulary is broken into three phases and a perioperative group of medications:

Phase A:  0–7 Days
  • Phase A covers a specific set of drugs that can be prescribed and dispensed without prior authorization provided that the supply does not exceed 7 days (unless it is an antibiotic that has a longer course of treatment).
  • It is prescribed at the initial treatment visit within the first 7 days following the date of the disability event, and the dispensing occurs within the first seven days of the initial treatment.  
  • However, a Phase A drug that is also a Phase B drug may be prescribed for up to 30 days if the other time conditions are met. Phase A drugs that are prescribed outside of these criteria would be subject to prior authorization.
Phase B:  8–30 Days

Phase B covers a specific set of drugs that may be prescribed and dispensed without prior authorization from the eighth to the thirtieth day following a disability event if the supply:

  • Does not exceed 30 days.
  • The drug is prescribed at an initial or follow-up visit.
  • The dispensing occurs within 7 days of the date of treatment.
  • The case has not been accepted by the carrier or established by the WCB. 
  • Once the claim is accepted by the carrier or established by the WCB, all drugs must be prescribed consistent with Phase C.
Phase C:  After 30 Days
  • Phase C covers specific drugs that may be prescribed without prior authorization after 30 days following a disability event, or once the carrier has accepted the claim or the WCB has established the claims.  
  • Phase C drugs must be prescribed in accordance with the established treatment guidelines.  
  • Phase C 2nd Drugs may be prescribed and dispensed without prior authorization following the trial of a first line Phase C drug. 
Perioperative
  • Perioperative designated drugs may be prescribed without prior authorization in the four days prior to and four days following a surgical procedure.
  • Perioperative drugs require prior authorization if prescribed outside of the perioperative period unless they are designated for another Phase and are prescribed in accordance with the guidelines of that Phase.  

Prior Authorization Process

The rule also details when drugs are subject to the prior authorization process:

  • Drugs listed on the formulary as a phase drug when prescribed outside of the guidelines for the phase designated.
  • Brand drugs when a generic is available.
  • Non-Formulary drugs (drugs not listed on the formulary).
  • Compounded medications that contain non-formulary ingredients or compounds with formulary drugs being prescribed with a non-FDA approved route of administration.
  • Formulary drugs being prescribed in a manner inconsistent with the medical treatment guidelines, except Phase A and B drugs.
  • Prior authorization must be sought prior to the time the drug is prescribed.
  • Carriers and administrators may deny payment for a drug that was not prior authorized when required.
  • Carriers and self-insured employers must provide two levels of review for prior authorization. 
  • Carriers and self-insured employers must provide contact information to the WCB for individuals responsible for the two levels of review:
    • The first level of review is the initial review when a drug requires prior authorization.
    • The second level of review is when the prescriber requests a review of a denial that occurred during the first review.  The request must occur within 10 days of the denial and the second review must be completed by the carrier or administrator’s physician.

Other Provisions

  • If the second review results in a denial, the prescribing physician may file an appeal with the WCB Medical Director’s Office.  Decisions by the WCB Medical Director are final and not appealable.
  • The drug formulary will be updated at least annually.
  • If a conflict existed between the drug formulary and the medical treatment guidelines, the medical treatment guidelines prevail.

The effective date of the drug formulary, if approved in its current form, would be 6 months from the date the rule is adopted for new prescriptions, and 12 months for refill and renewal prescriptions. Carriers will be required to identify all claimants currently receiving non-formulary drugs and provide notice to the claimant and the prescribing physician listing the impacted medication, the process for determining a suitable formulary alternative, and the process for seeking prior authorization approval in the event there is not a formulary drug that meets the need of the claimant.

Comments on the proposed rule are due by November 15, 2018.

Mitchell is currently evaluating the rule and its impact and will be providing comment based on that evaluation. While there are some areas of concern, there are positive aspects in the proposed rule that we applaud. For example, strengthening the prior authorization process for compounded medications could have the benefit of improving patient health and decreasing fraud. Additionally, requiring prior authorization for brand medications when a generic is available will help increase adherence to the generic mandate that is currently in law. It is also important to note that the WCB did react to comments submitted in response to the initial draft of the rule and they either revised or eliminated some of the more problematic provisions that would have had unintended consequences.

Information about the revised New York drug formulary rule along with text of the new draft can be found here.


For questions regarding this alert, please contact Brian Allen, Vice President of Government Affairs, at Brian.Allen@mitchell.com or at 801.903.5754.

 

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