Board Enacts Prescription Drug Formulary – Effective 6/5/19!
The April 2017 WC reform legislation, §13-p, required the Board to “establish a comprehensive prescription drug formulary on or before 12/31/17.” At last, effective 6/5/19, the Board has adopted the finalized Drug Formulary and proposed regulations, Part 441 of Title 12 of the NYCRR. The Board did not notify stakeholders by Subject Number, as would be expected with a significant regulatory change. Instead, the Board updated the “Health Care Information” section of its website to include a link to the Formulary and regulations.
Effective Date and Notice Requirements
Within six months of the 6/5/19 effective date, all new prescriptions must comply with the formulary, and within twelve months, all refills and renewals must comply. Also within six months of the effective date, Carriers and Self-Insured Employers (SIE) must identify all claims that have a current prescription for a Non-Formulary drug and, on a format prescribed by the Board, provide written notification to claimants and treating providers. The regulation does not require notice to Claimant’s counsel.
Carriers and SIEs must provide the Board, in the manner prescribed by the Chair, correct and complete contact information for the first and second level review levels within 30 days of the effective date, (6/5/19). Failure to provide the information within 6 months of the effective date, or failure to update the information upon a change, could subject Carriers and SIEs to Orders of the Chair and penalties. The due date for providing this information to the Board is Thursday, 7/4/19.
Prior Authorization and Formulary Drugs
Formulary drugs do not require prior authorization if prescribed in accordance with the Formulary. Of note, there are two significant special considerations. The first is designated in the formulary as “#1” and states that certain drugs are not to exceed a 7 day supply. These drugs include opiates, anti-anxiety medications, and muscle relaxants. Special consideration “#2” allows for the medication to be prescribed for the full course of treatment, (e.g. penicillin and anti-infectives).
There are three lists of drugs in the Formulary and detailed in Rule 441.4. Phase A are drugs that can be prescribed within 30 days of the accident or until a case accepted or established, for up to 30 days, except that controlled substances and muscle relaxants can only be prescribed for up to 7 days, and anti-infectives can be prescribed for the recommended course. Phase B drugs can be prescribed 30 days post accident or once the case is accepted or established, whichever occurs first, for up to 90 days and in accordance with Medical Treatment Guidelines (MTG) as applicable. Phase B formulary drugs allow for 2nd line drugs designated as “2nd” and only after a trial of 1st line drugs in accordance with Formulary. Perioperative drugs are those prescribed during the period 4 days before and 4 days after claimant goes to hospital, clinic or doctor’s office for surgery, with day of surgery being day 0. These drugs include analgesics (non-topical), one anti-convulsant (Gabapentin) and anti-inflammatories.
The prior authorization process is detailed in Rule 441.5. The treating provider must request authorization before prescribing or dispensing:
- Phase A, B or Perioperative drugs other than as set forth in these regulations;
- Brand name drugs if a generic equivalent available, even at different dosages and strength;
- Any Non-Formulary drug;
- Any Compound drugs;
- Formulary drugs in an accepted or established case in a manner inconsistent with the MTG if applicable.
Carriers and SIEs may deny payment if the treating provider did not request prior authorization when it’s required. If a case apportioned between multiple files, the treating provider must request prior authorization of each Carrier and SIE.
For the first level of review, the request cannot exceed 365 days, and if no limit is mentioned, the default is 30 days. Carriers and SIEs have 4 calendar days to respond. This level need not be reviewed by a medical doctor, and can be approved, denied or partially approved. Specific reasons are required for denial or partial approval. A denial or partial approval must also provide information on how to request review from the Carrier’s Physician. The lack of a timely and proper reply subjects Carriers and SIEs to an Order of the Chair and eliminates the option of objecting to payment of the drug without risk of penalty.
A treating provider may request a second level review within 10 calendar days of denial or partial approval. Such request must include information responsive to the denial or partial approval. This request is made to the designated contact (Carrier’s Physician who must be a licensed physician). The Carrier’s Physician has 4 calendar days to approve, partially approve or deny. The failure to timely and properly reply subjects Carriers and SIEs to an Order of the Chair and eliminates the option of objecting to payment of the drug without risk of penalty.
The third level review is the final level for the treating provider, Carriers and SIEs. It must be filed by the treating provider within 10 calendar days of a denial or partial approval. It must be submitted to the Medical Director’s Office (MDO) in format to be prescribed by the Chair, with all documentation in support of the requests and both levels of denials or partial approvals. The MDO decision is final and binding, and not appealable, except the claimant may request review by filing an RFA that demonstrates the drug is medically necessary and denial adversely impacts the claimant’s interests. The Board may respond by letter or make a referral to adjudication, and such decision is binding and not appealable. It remains unclear if this means the letter, the referral, the result of adjudication or all are binding and not appealable.
If prior authorization is denied on the merits, no new request can be submitted absent evidence of a change in condition which renders the prior denial no longer applicable.
All communication must be by electronic delivery unless the treating provider certifies that his/her office is not equipped for such delivery.
The Formulary is to be updated at least annually.
The Medical Treatment Guidelines prevail if there is a conflict with the Formulary unless the drug is prescribed in accordance with Phase A or B of Formulary.
It does not appear that any of the forms referenced in the Formulary or regulation have yet been promulgated. For further information concerning the Pharmacy Formulary, please contact our partner Renee Heitger.