State News : Pennsylvania

On January 2, 2024, the Pennsylvania Commonwealth Court issued what may be a decision that has significant effect upon workers’ compensation liability for insurers and self-insured employers, the pharmaceutical industry and may for injured workers as a consequence of the Decision.  In Federated Insurance v. Summit Pharmacy, the Court set aside the Bureau of Workers’ Compensation’s regulatory adoption and use of Red Book values as setting the Average Wholesale Price (AWP) to resolve payment disputes for pharmaceuticals.  It noted that doing so was inconsistent with the phrase AWP as utilized in Section 306(f.1)(3)(vi)(A) as has been interpreted by the Court.  If an agency’s regulations are inconsistent with the legislative intent of the statutory provisions, the regulations are invalid.  Thus, the Court invalidated utilizing Red Book values as to AWP when determining what amount needs to be paid under the Pennsylvania Workers’ Compensation Act and corresponding Medical Cost Containment Regulations when remitting payment for prescription medications.  The Court ordered the Bureau to promptly identify a “Nationally recognized schedule” of AWP which is to be utilized as being the basis of payment for prescriptions. 

This case had its genesis in a dispute over an alleged underpayment of approximately $72,500.00 for prescription medications.  The prescription bills submitted from 04/15/21 – 09/08/22 totaled $74,011.81 and payment was made by the carrier using the AWP of the drugs are reported in the National Average Drug Acquisition Cost Index (NADAC), which totaled $1,511.93.  The Bureau’s Fee Review Section issued determinations apply the costs per Red Book, based upon the cost containment regulations promulgated under the Act.  See 34 Pa. Code §§127.1 – 127.755; see also Section 306(f.1)(3)(vi)(A) of the Act, 77 P.S. §531(3)(vi)(A), which limits reimbursement for drugs and professional pharmaceutical services to “one hundred ten per centum of the … [AWP] of the produce, calculated on a per unit basis, as of the date of dispensing.” 

The Carrier argued that Red Book pricing was artificially inflated and did not accurately represent the actual AWP, which is what the Act required to determine pricing for pharmaceuticals.  It was noted that Red Book is a privately published, electronic compendium of pharmaceutical and over-the-counter “AWPs” available online.  The publisher of Red Book is IBM Watson, which has changed over the years.  It the statement policy, even IBM Watson indicated that, in most cases, the manufacturer’s AWP does not reflect the actual AWP charged by the wholesaler.  The values used in Red Book were what was reported by the manufacturer and IBM Watson did not independently analyze the data to ascertain the amounts paid by pharmacies to wholesalers.  Accordingly, it was asserted that Red Book values were inconsistent with the Act and cost containment provisions.  The Court looked to prior case law, Indem. Ins. Co. of N. Am. v. Bureau of Workers’ Comp. Fee Rev. Hearing Off. (Insight Pharm.) 245 A.3d 1158 (Pa. Cmwlth. 2021) to conclude that the plain meaning of AWP is a price which is an industry average and not one “charged by a single manufacturer,” and “is a number derived by averaging the wholesale prices of all manufacturers or wholesalers.”

While the Bureau adopted Red Book as AWP to be used in payment disputes, it was noted that an insurer may introduce evidence challenging the “accuracy” of the Red Book pricing.  Here the carrier challenged the use of Red Book on the basis that its values can never reflect an accurate AWP.  It was noted that NADAC pricing was based on the aggregated and averaged prices pharmacies typically pay for a drug at wholesale nationally. Whereas, Red Book pricing was chosen unilaterally by a drug’s manufacturer and was not a mathematical average.  It was not based upon an prices in actual wholesale transactions.  The prices under Red Book and NADAC differed considerably, especially for generic drugs.  An example was the acquisition price of a bottle of Prozac, which was $9.00.  The Red Book price for reimbursement was $2,000.00.  Thus, at payment of 110% of AWP, the carrier’s payment could be $2,200 under Red Book or $9.90 under NADAC. 

The Court agreed that the Bureau’s regulatory adoption of Red Book’s values as to AWP to resolve payment disputes was inconsistent with the phrase AWP as used in the Act and that an administrative agency’s regulations cannot conflict with the statutory intent.  Thus, they held as a matter of law that Red Book’s values could not be used as to AWP because they are inconsistent with the Act.  The Court however, did not indicate that NADAC is to be utilized.  Instead, it remanded and directed the Bureau to “promptly identify and publish” in the Pennsylvania Bulletin a “National recognized schedule to determine the AWP of prescription drugs” to be used to resolve payment disputes.

Thus, we are now left with a situation in which there is uncertainty as to what amount is payable for any prescription submitted for reimbursement.  It is uncertain as to when the Bureau may publish a new National recognized schedule.  Does this excuse or toll the payments to now be issued for prescription medications for which bills are submitted.  If payment is not made within 30 days of receipt of the bills, typically statutory interest is to start to accrue on the payment to be issued.  Should carriers now start to pay under NADAC and then if a different schedule is implemented, pay any difference in the amount payable along with interest on the additional payment.  The Bureau may well adopt NADAC.  However, it is not bound to do so.  It should be noted that with the drastic difference in the amount payable, pharmacies may elect to not fill some drugs for workers’ compensation claims.  In the Decision, the expert for the pharmacy indicated that the cost to fill a prescription is $12.50 per prescription such that the pharmacy would be losing money any time they fill a script for a mediation that has an AWP that does not provide for payment above this amount.  This could be problematic for injured workers if they are no longer able to secure certain mediations if pharmacies do not find it cost effective to provide.   However, with how inflated Red Book values are, it is obvious that pharmacies have been significantly profiting to the detriment of insurers and self-insured employers for years relative to the cost of prescription medications.  More likely than not there will be more comment and discussion about how to come up with a schedule that makes sense for all stakeholders.

The Medical Cost Containment Regulations were enacted back in 1994.  They may no longer be adequate in a number of ways in terms of addressing issues that arise in the workers’ compensation and fee review forums.  It may be time for the General Assembly of Pennsylvania to revisit the regulations, seek commentary from all stakeholders and to address any and all deficiencies that are arising either from the regulations not accurately reflecting the times as to payment for medical treatment and pharmaceuticals as well as addressing cases that have been rendered over time that appear inconsistent with the Act and regulations that have led to even further confusion over implementation and interpretation of the Act and Regulations.  This case is most likely going to have a significant financial impact upon carriers in Pennsylvania as well as pharmacies and injured workers’ may also feel the fallout.  However, other than simply forms the basis for determining the cost of prescription mediations moving forward, perhaps, it will provide the impetus for even more broad and sweeping changes regarding the payment of medical treatment under the Pennsylvania Workers’ Compensation Act.