Pharmacy Benefit Manager Legislation and the Impact on the Pharma Supply Chain

The Cost of PBMs

Last week, Senator Elizabeth Warren (D-Massachusetts) and Josh Hawley (R-Missouri) introduced a bill requiring healthcare companies that own health insurers or pharmacy benefit managers (PBMs) to sell pharmacy assets within three years. If this legislation were to pass, it would significantly impact the pharmaceutical supply chain and perhaps help to control rising medication costs.

The bill, titled the Patients Before Monopolies (PBM) Act, seeks to address a variety of objectives focused on lowering costs for patients and allowing independent pharmacies a more favorable market environment. Advocates of the bill claim pharmacy benefit managers (PBMs), or the middlemen between pharmacies and insurance companies, have become “conglomerates” that profit at the expense of consumers and smaller pharmacies.

The New York Times recently published an article highlighting the impact of PBMs on consumers and smaller pharmacies alike. Yough Valley Pharmacy, which had served residents of the rural community of Confluence, Pennsylvania for decades as its only healthcare provider, was recently forced to close its doors as a result of the actions of PBMs. According to the article, “PBMs frequently pay (smaller independent) pharmacies at rates that do not cover the costs of the drugs, according to more than 100 pharmacists around the country and dozens of examples of insurance paperwork and legal documents.” Situations like Yough Valley Pharmacy are unfortunately not uncommon.

Objectives of the PBM Act

The PBM Act would place a ban on spread pricing, which is when PBMs pay a lower amount for dispensing a pharmacy and raise the price when they sell it to a health plan (i.e. an insurance company). These PBMs then keep the “spread” as profit. Additionally, the new law would delink PBM fees from the list price; proponents of the bill argue PBMs have pushed higher-priced medicines that earn them higher commissions, as opposed to lower-cost alternatives that save their patients and employers money.

Other components of the bill include (per the Elizabeth Warren Senate Website):

  • Prohibiting a parent company of a PBM or an insurer from owning a pharmacy business;
  • Requiring that a parent company in violation of the PBM Act divest its pharmacy business within three years;
  • Enabling the FTC, Department of Health and Human Services, Antitrust Division of the Department of Justice, and state attorneys general to issue orders requiring violators of the PBM Act to divest its pharmacy business and disgorge any revenue received during the period of such violation;
  • Directing the FTC to distribute any disgorged revenue to harmed communities, including consumers overcharged at vertically integrated pharmacies.
  • Mandating reporting of all divestitures to the FTC, and allowing the FTC to review all divestitures and subsequent acquisitions to protect competition, financial viability, and the public interest.

PBMs and the Pharmaceutical Supply Chain

With sources indicating this bill could likely pass within the next few days, it’s important to discuss how the PBM could affect the pharmaceutical supply chain:

  • Transparency and pricing reforms; the will may introduce stricter transparency requirements for PBM’s, such as mandating pricing methodologies, rebates, and fees. This could lead to improved negotiation dynamics between different trading partners throughout the supply chain.
  • DSCSA compliance: enhanced transparency could streamline the implementation of interoperable electronic systems from product-level drug tracking.
  • Supply chain optimization: improved coordination among PBMs, manufacturers, and wholesalers may help streamline distribution processes.
  • Risk of increased complexity: If the PBM Act requires additional reporting or operational requirements, trading partners may have trouble implementing these requirements with existing DSCSA protocols.

What do you think about the Patients Before Monopolies (PBM) Act? What impact could its passing have on the pharmaceutical supply chain?

Trump’s Tariffs and Drug Prices

Following his election victory, president-elect Donald Trump announced intentions of implementing tariffs on Canada, Mexico, and China; these tariffs include 25% tax on imports from both Mexico and Canada, and an additional 10% increase on the tariffs already in place on Chinese exports to the United States. The goals of these imports, according to the Trump administration, are to protect U.S. manufacturing; incentivize companies to build facilities in the U.S. (and create American jobs); provide billions to the federal reserve to help offset the cost of tax cuts; and deter the flow of illegal immigrants, fentanyl, and other illicit drugs.

However, those opposed to the tariffs (including many economists) emphasize how taxing goods could result in price increases for consumers, including prescription drugs. About 85% of the Active Pharmaceutical Ingredients (APIs) used by U.S. manufacturers for generic pharmaceuticals are from India and China; Mexico and Canada are also exporters of these materials. Taxing these APIs as they enter the United States could result in higher prices for finished goods. Companies importing these goods may simply pass the cost of the tariffs to end consumers, who are already burdened by inflation.

According to the Active Pharmaceutical Ingredient Innovation Center (APIIC), this overreliance on China, India, and other foreign nations for most of our APIs is detrimentally impacting the supply of essential medications in the United States. The APIIC also believes rising imports of pharmaceuticals to the U.S. “creates serious risks to national security and patient safety.” In the past decade, the number of API-facility locations has decreased by 61%, while foreign nations continue to scale their operations. Reshoring the manufacturing process could help mitigate these concerns, and eliminate the financial risk of higher costs associated with tariffs; could Trump’s tariff plan present further opportunity to invest in domestic API production facilities?

What do you think about the impact of tariffs on drug prices? Will tariffs raise prescription drug prices, or could the benefits of in-country production outweigh the potential-price hikes in the long run?

What Isn’t Included in the Recent Exemption

Who Does It Apply To?

Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption.

First, as noted in my previous posts, the recent exemption doesn’t apply to everyone. As the FDA emphasized in their release, trading partners who are eligible for the exemption include “those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners”, and “those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” In other words, now is not time for trading partners to start initiating their systems and processes (that ship has sailed)—it’s time for trading partners to refine them.

Progress Necessary

The FDA wants to see progress made toward finalizing systems and processes capable of exchanging DSCSA transaction information and transaction statements with one another. Key enablers of this progress include:

  • Reconciling receipts of digital and physical representations of Serialized Information
  • Investigating suspect process
  • Verifying product for saleable returns
  • Responding to a trace request

In addition to documentation of progress, the FDA expects trading partners who plan to rely on the extension to communicate their intentions with immediate trading partners.

The FDA, similarly to when they announced their decision to implement the stabilization period, does not want trading partners to view this exemption as a “justification for delaying efforts to implement enhanced drug distribution security requirements.”

The deadline for compliance will come sooner than many expect, especially for manufacturers. In fact, there are only 129 working days until the May 27th, 2025 EDDS deadline.

Risks of Noncompliance

For those who haven’t initiated these systems and processes, punishments could be severe, and include:

  • Regulatory Risks: Potential for regulatory actions like warning letters, import alerts, or product seizures.
  • Operational Disruptions: Potential for supply chain disruptions and delays in product acceptance.
  • Market Exclusion: Risk of being completely excluded from the supply chain

Partners who do not meet the exemption criteria will need to submit a Waiver, Exception, or Exemption, or will more than likely face the consequences outlined above.

Stabilization Behind Us

Navigating DSCSA compliance amidst the constant changes to legislation can be tricky. However, one thing is for sure: if your business lacks systems and processes in place to implement EDDS requirements, the business is at risk.

With stabilization behind us, let Gateway Checker put you on the fast path towards supply integrity and regulatory compliance. Visit our website to view our services, or contact our team with any questions.

So, You Think You’re Exempt

DSCSA Deadline: Just Days Away

The deadline for DSCSA stabilization is just days away, mandating Enhanced Drug Distribution Security (EDDS) requirements for manufacturers, repackagers, wholesale distributors, and dispensers. While the FDA announced an extension from certain components of the FD&C in the form of a phased approach, this extension only applies to certain eligible trading partners. Eligible trading partners include those who have either completed connections with immediate trading partners, or who have initiated efforts (with documented evidence) but could not complete them by the November 27th deadline.

The phased approach to exemptions arose after industry stakeholders and House of Representatives members called for additional reform, emphasizing how a lack of government intervention can lead to drug shortages. The deadline for eligible trading partners is as follows:

  • Manufacturers and Repackagers: May 27th, 2025
  • Wholesale Distributors: August 27th, 2025
  • Large Dispensers (>25 fulltime employees): November 27th, 2025
  • Small Dispensers (<25 fulltime employees): November 27th, 2026

In light of these exemptions, it’s important that we understand the details: who is and isn’t exempt, and from what specific requirements are eligible trading partners exempt from?

Who Is Actually Exempt? For How Long?

Unlike the 1-year stabilization period announced in August of 2023, this exemption only applies to certain eligible trading partners. To be eligible for the exemption, trading partners must have initiated their systems and processes in alignment with requirements outlined in section 582(g)(1) of the FD&C Act by the November 27th, 2024, start date. Section 582(g)(1) mandates the exchange of transaction data in an electronic and interoperable manner, implements procedures for product verification, and requires partners to keep transaction records in the case of a recall or in case product may be illegitimate or counterfeit. The announcement states,

“In order to prevent confusion, the FDA made it very clear in their announcement who they consider eligible for the exemption; they stated, “eligible trading partners are those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners and those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.”

Additionally, this exemption “extends to trading partners throughout the pharmaceutical distribution supply chain who subsequently transact such product.” In other words, if a manufacturer is exempt and sends product downstream to a wholesale distributor, then that partner would be exempt for that product as well.

It’s also important to highlight the specific regulations eligible partners are exempt from. The announcement clarifies eligible partners are only exempt from certain subsections of 582(g)(1), 582(c)(4), and 582(d)(4). These specific regulations are as follows:

  • Section 582(g)(1) (A-F) for manufacturers and repackagers, wholesale distributors, and dispensers with 26 or more full-time employees
  • Section 582(c)(4)(D) For Wholesale Distributors
  • Section 582(d)(4)(A)(ii)(II) and (B)(iii) for Dispensers with 26 of more full-time employees

To read these specific requirements in full, click here.

How to Prepare for November 27th and Beyond

With FDA inquiries and audits to confirm compliance on the horizon, here’s a few steps you can take to ensure you aren’t at risk:

  1. Confirm the “Who” and “What” of the Recent Exemption:Understand if you are eligible, and if so, from what specific regulations you are exempt from.
  2. Test your exchanges: Testing exchanges is the best way to ensure your organization meets federal requirements. Gateway Checker’s TraceReady™ platformevaluates DSCSA conformance and compliance in line to the receiving and fulfillment process, enabling continuous quality assurance for your transactions.
  3. Prepare ahead of time: don’t see these exemptions as an excuse to delay compliance efforts. By preparing your systems before the deadline, you prevent disruptions to supply chains down the line, avoid potential penalties of noncompliance, and demonstrate your commitment to supply chain security.
  4. Communicate Consistently: by communicating your challenges consistently with your trading partners, you can address any complications before the deadline.
  5. Ask questions: The Gateway Checker team is here to support compliance efforts, no matter where you are in the process. Whether you need help providing evidence of data exchanges to trading partners, support communicating extension reliance, or need help meeting extension eligibility requirements, don’t hesitate to contact us.

 

 

What Is Exempt, per recent DSCSA Update 

According to the DSCSA Exemption Announcement from the FDA on October 9th, here are the specific components of the legislation that eligible trading partners are exempt from. 

Section 582(g)(1)(A-F) for Manufacturers and Repackagers, Wholesale distributors, and Dispensers 

‘‘(A) The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection. 

‘‘(B) The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction. 

‘‘(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary. 

‘‘(D) The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary (or other appropriate Federal or State official) in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required. 

‘‘(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required—  

‘‘(i) in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or 

‘‘(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause (i). 

‘‘(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the trans- action information and transaction statement associated with that product. 

Section 582(c)(4)(D) For Wholesale Distributors 

(D) VERIFICATION OF SALEABLE RETURNED PRODUCT: Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act, upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

Section 582(d)(4)(A)(ii)(II) and (B)(iii) for Dispensers with 26 of more full-time employees* 

‘‘(II) Dispenser must promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product beginning 7 years after the date of enactment of such Act, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all pack- ages, if there are fewer than 3, corresponds with the product identifier for such product 

‘‘(iii) RESPONDING TO A NOTIFICATION —Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A). 

*Recall that an exemption was given to dispensers with 25 or less full-time employees already until November 27th, 2026. This is one year after the dispensers with 26 or more full time employees. 

For any questions regarding the exemption, feel free to contact the Gateway Checker team