New York, NY (WorkersCompensation.com) – New York’s Workers’ Compensation Board may be hoping the third time is the charm to adopt a drug formulary. A notice of proposed rule making was published in the State Register this week. While it simplifies aspects of the first two proposals — published in December 2017 and October 2018 — it also leaves some questions unanswered and may create some confusion.
“It’s incredibly nuanced,” said David Price, director of Government Affairs for Preferred Medical. “It’s meant to include more nuance than others, but that means it’ll be more complex for providers, payers, and pharmacy benefit managers. It will require a substantial amount of implementation and communication between stakeholders.”
The Board initiated a 30-day public comment period, beginning January 23.
“A drug formulary that includes high-quality and cost-effective preauthorized medication,” is the idea behind the proposal, according to the text. Drugs in the formulary do not require prior authorization from the insurer or self-insured employer.
Drugs included in the formulary fall into one of three phases:
- Phase A – covering medications in the first 30 days after an injury
- Phase B – covering medications beyond the first 30 days after an injury
- Perioperative phase — covering medications prescribed in the period stretching from four days prior to surgery to four days following surgery, with the day of surgery being ‘day zero’
Additionally, some drugs are categorized as ‘second-line therapy.’ These are to be used only when other drugs associated with the injury and phase of treatment have been deemed ineffective.
Prior authorization would be required for
- Drugs not included in the formulary
- ·Formulary brand name drugs when a generic is available
- ·A brand name drug when a generic version with the same active ingredient(s) is commercially available in a different strength/dosage. For example, if a generic drug is available in 5mg and 10mg a brand name drug in 7.5 mg would require prior authorization.
- Compound medications with any non-formulary ingredient or with formulary ingredients prescribed for a non-FDA approved route of administration, such as topics, oral and/or systemic.
- Combination products, “unless specifically listed in the formulary.”
Some medications are marked as ‘special considerations.’ Among them are drugs that can only be prescribed and dispensed one time only without prior authorization, for a maximum of a 7-day supply. In addition to the anti-anxiety agents Alprazolam and Buspirone are the following analgesics-narcotics:
- ·Morphine (Short Acting)
- Oxycodone HCl (Short Acting)
- Tramadol HCl (Short Acting)
A footnote says “Prescriber should consider appropriateness of naloxone when prescribing opioids. The WCB supports the NYS DOH recommendations. After appropriate claimant assessment, if in the prescriber’s judgement it is appropriate for the claimant to obtain naloxone, the provider should submit a prior authorization request.”
- Compound medications. Contrary to what workers’ compensation stakeholders may have expected, the latest proposal does not explicitly ban the use of compound medications.
“The Board noted that ‘several commenters’ recommended requiring prior authorization for all compound drugs instead of just those containing a non-formulary drug; however, the Board didn’t really offer an explanation as to why preauthorization shouldn’t be required for all compound drugs. Instead, in its response to those comments, the Board simply re-asserted that the formulary would require prior authorization for compounds that include a non-formulary ingredient,” Price said. “The fact that a customized compound medication is not FDA-approved and not recommended by the medical treatment guidelines (MTG) or any other objective medical evidence, but still somehow exempt from prior authorization requirements seems at odds with the purpose of the formulary.”
Price and others are also perplexed by another issue. “While it’s not mentioned anywhere in the proposed rules, the formulary document itself does mention that prior authorization is required for ‘combination products’ that are not explicitly listed in the formulary. Unfortunately, the term ‘combination products’ isn’t defined. Generally speaking, this term isn’t used to describe compound medications.”
- 2nd line medications. The ‘second line therapy’ inclusion may cause some confusion. “Payers and their PBMs will need to look at the patient’s drug history and determine whether the new medication is being prescribed as a first-line medication or a second-line medication,” Price said. ”It potentially requires more work. It will depend on how thorough the records are and how easily accessible they are.”
- Anti-opioid medication. Finally, there is the issue Naloxone. “The Board mentions it as a footnote, but doesn’t say if requires prior authorization,” Price said. “It’s not included in the formulary itself; although it probably would require preauthorization.”