Regulatory Market Update

We want to keep you up-to-date with relevant, timely industry insights and regulatory updates that may impact your business. If you have questions on any of the content found in this or other newsletters, reach out to your IntegriChain Consulting Lead or advisory@integrichain.com and we would be happy to talk you through it.

 

In Case You Missed It:

On April 8th, IntegriChain hosted an informative discussion with Rupal Patel, Director of Consulting Services, and John Whitridge, Senior Manager of Consulting, to discuss the current state of drug pricing transparency laws. Listen to the webinar replay, or read our latest blog with a summary of the discussion.

 

New Virginia State Price Transparency Report

The Virginia annual price increase report is effective on January 1, 2022. Manufacturers that take a qualifying price increase during the previous year shall report annually by April 1 to the nonprofit organization with which the Department of Health has entered into a contract or agreement for each product that took a price increase above the specified threshold during the previous year. The price increases should be measured as the difference between the WAC of the generic drug after the increase and the average WAC of such generic drugs during the previous 12 months.
A brand-name drug and biologic other than a biosimilar with a WAC of $100 or more for a 30-day supply or a single course of treatment and an increase of 15% or more in WAC over the preceding calendar year. A generic drug with a price increase that results in an increase in the WAC of such generic drug that is equal to 200% or more during the preceding 12-month period, when the WAC of such generic drug is equal to or greater than $100, annually adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day supply, defined as the difference between the WAC of the generic drug after increase and the average WAC of the generic drug during the previous 12 months.

Link to read more:

Virginia.gov Bill Tracking – 2021 session

Michigan Becomes the Next State to Adopt Price Transparency Reporting

The latest bills from Michigan aim to expand access to affordable medication by allowing pharmacists to talk with patients about their options. The main goals of the plan are to place a cap on out-of-pocket costs for insulin, create better access to oral chemotherapy treatments, limit unregulated prescription middle that manipulates the drug prices. It also required drug makers to provide details on how prices are set on drugs. If you believe this will have a direct impact on your product please reach out to our pricing transparency consulting services at price.transparency@integrichain.com.

Link to read more:

Michigan House approves bills for transparency in pharmacies, health care

 

Maine’s Medicaid Supplemental Program Annual Manufacturers Fee

Maine has implemented a new fee that any manufacturer of prescription drugs that are provided to residents in Maine through the MainCare (Medicaid) program or Maines Elderly Low-Cost Drug Program must pay an annual $500.00 fee. This fee is per manufacturer and must be paid by May 1, 2021, to the Maine Department of Health and Human Services. 

This 2021 Annual fee is for 2020 Utilization and if the company has a presence in the state of Maine with direct sales, the use of sales representatives, other promotional activity, or a rebate agreement with the State of Maine, your company owes the fee. This applies even if the drug was discontinued in 2020. If the company only manufactures OTC drugs then you are excluded from the fee. The manufacturer fee is not part of the Drug Rebate, as that is a separate fee. This fee is to provide funding to the prescription drug academic detailing program.

 

Texas COI: New Portal Requiring Registration Effective April 1, 2021

As of April 1, 2021, the Texas Health and Human Service Commission will no longer accept Form 1326. This form is being replaced with a browser-based eCOI application which replaces the 1326 paper form. This is used for when there is a new drug on the market or an existing drug on the Texas Drug Code Index has a labeler changed or a new formulation.

There are a few rules a drug must have to be considered for inclusion on the TDCI:

• A rebate agreement with the centers for Medicare & Medicaid Services
• A listing on the Medicaid Drug Rebate Program website
• A listing on First Databank and Medi-Span

Manufacturers (or vendors on behalf of the manufacturer) who access the portal, must complete the access form 1403 as the first step in the process. The portal is also used to announce any changes regarding the information drug companies with one or more of their products in the TDCI. Any drugs that are submitted in the portal should include the NDC of the company as well as the label of the container sold to the pharmacy. The FDA approval letter is required for the submission of COI.

More details can be found here:

Texas Vendor Drug Program User Guide