Editor’s Note: This month, we offer pharmaceutical market updates on three significant topics. As always, if you have questions on any of the content found in this or previous market updates, please reach out to your IntegriChain Consulting Lead or consulting@integrichain.com and we would be happy to talk you through it.

---

ICYMI – Pharma Market Access News

Medicaid Drug Rebate Program (MDRP): US Territory Enrollment Updates 

• Puerto Rico’s Health Insurance Administration, ASES, opted into the MDRP as of January 1, 2023, and will utilize its PBM (Abarca Health) for processing claims and submitting invoices starting 60 days after the end of Q1.
• Guam has currently opted out of the program through March 31, 2028.
• US Virgin Islands received preliminary approval for a waiver as of March 30, 2023, with a 30-day comment period.
• American Samoa and Northern Mariana Islands do not appear to have any waivers as of yet. 

References

• Medicaid

Puerto Rico Medicaid Drug Rebate Program Claims Administrator

Per CMS Release #117, pharmaceutical manufacturers were required to include all sales of Covered Outpatient Drugs (CODs) from Puerto Rico in their AMP and Best Price calculations as of January 1, 2023. As such, manufacturers should expect to start receiving invoices from Puerto Rico within the next month or so.

Abarca Health LLC, Puerto Rico’s Pharmacy Benefit Manager (PBM), has been designated to provide PBM services for the Puerto Rico Medicaid program. Abarca will be adjudicating and providing both Medicaid and Managed Medicaid claim invoices to pharma manufacturers.

Manufacturers may expect to receive invoices from ASES that will be separated into the following programs: OBRA, MCO OBRA, JCODE, MCO JCODE, CHIP, MCO CHIP, CHIP JCODE, and CHIP MCO JCODE. 

References

• MDRP Manufacturer Release No 117, January 23, 2023
• ASES ABARCA Announcement

TAA Compliance and its Relevance to FSS Agreements

According to the Trade Agreement Act of 1979 (TAA), the US government must purchase products that are manufactured in the US or from countries that participate in specific trade agreements with the US. These countries are referred to as TAA-compliant countries. Therefore, per pharmaceutical manufacturers’ Veteran’s Administration Federal Supply Schedule (VA FSS) contract agreements, the country of origin for all drug products being sold to the VA must be from TAA-compliant countries. Non-TAA-compliant drug products can still be offered by manufacturers to the VA via their FSS contract; however, the VA as a government buyer does have the option to decline the purchase of any non-TAA-compliant products offered on a manufacturer’s FSS contract.

For reference, there are 126 TAA-compliant countries. The eleven countries that are not compliant are Brazil, China, India, Indonesia, Iran, Iraq, Malaysia, Pakistan, Russia, Sri Lanka, and Vietnam.  

References

• Federal Acquisition Regulation
• TAA Designated Countries
• Trade Agreements Act

State Price Transparency Reporting Updates

We have received updates from the states of Louisiana, Oregon, and Florida and wanted to provide a summary of the State Price Transparency Reporting changes and how it will impact Pharmaceutical companies moving forward.

Louisiana

Due to grant funds no longer being available to fund Louisiana’s reporting website, the existing web portal will no longer be available as of July 1, 2023, but the state has clarified that the reporting requirements are still in effect and quarterly WAC reports are to be submitted via email directly to the state beginning with the Q3 2023 reports due by July 1, 2023.

Reports are to be emailed in spreadsheet form to the Board of Pharmacy at info@pharmacy.la.gov with the subject line: Pharmaceutical Cost Transparency Reporting.

Quarterly report spreadsheet requirements include Generic Name, Trade Name, Indicate Branded or Generic, Dosage Form, Drug Strength, Therapeutic Class, National Drug Code (NDC) Number, Package Size, and Per Unit Wholesale Acquisition Cost (WAC) of Product in USD.

Oregon

Oregon has added some rules to follow regarding registering manufacturers to their portal.  Some of the highlights that will impact manufacturers and IntegriChain are:

• Going forward, all customers must have their own username and password, which are not to be shared with IntegriChain.
• IntegriChain (and all third-party vendors) will have secondary credentials to log in and submit reports on the manufacturers’ behalf. 
• Only the manufacturer can control who has access to their account. 
• IntegriChain can no longer capture or track the manufacturers’ credentials for Oregon therefore, they will need to be tracked by the manufacturers themselves.

Florida

Florida passed its first State Price Transparency Reporting bill (SB 1550), which requires drug manufacturers to notify the Department of Business and Professional Regulation of reportable drug price increases. This bill is effective July 1, 2023.

Reportable drug price increases are defined as a “WAC increase of 15% or more during the preceding 12 months, or 30% or more during the preceding 3 calendar years, for a prescription drug of at least $100 per course of therapy.” Reports are required both on the effective date of the increase and annually by April 1 the year after the increase.

Enforcement and Penalties:

• SB 1550 states that failure to accurately complete and timely submit reportable drug price increase forms, reports, and documents as required under SB 1550 is a Prohibited Act under the Florida Drug and Cosmetic Act.
• Prohibited Acts may be subject to administrative fines, not to exceed $5,000 per violation per day, among other enforcement actions.

For more information on State Price Transparency, please contact the IntegriChain at price.transparency@integrichain.com.

GET MORE PHARMA MARKET UPDATES