<![CDATA[GLOBAL COMPLIANCE STRATEGIES - Blog]]>Thu, 30 Jul 2026 14:29:37 -0700Weebly<![CDATA[Louisiana ramps up price transparency efforts]]>Mon, 22 Jun 2026 15:12:41 GMThttps://www.glocomstrategies.com/blog/louisiana-ramps-up-price-transparency-effortsState legislatures are continuing their crackdown on rising healthcare costs by putting pharmaceutical manufacturer prices under the microscope.

On June 12, 2026, Louisiana Governor Jeff Landry signed into law Senate Bill 401 (enacted as Act No. 915), significantly ramping up the state's transparency requirements.

Here is what you need to know about Louisiana's new framework, how it stacks up against neighboring Texas, and what it means for the state's existing reporting landscape.

Summary of Louisiana SB 401 Requirements

Louisiana’s new law creates a Prescription Drug Affordability Board (PDAB)-centered transparency framework within the Department of Insurance and adds new manufacturer reporting obligations. The key components include:

  • Annual Pricing Disclosures: By January 15 of each year, drug manufacturers must submit current Wholesale Acquisition Cost (WAC) information for all FDA-approved prescription drugs sold in the state.
  • Price Increase Triggers: If a drug costing at least $100 for a 30-day supply sees a WAC increase of 15% or more in a single year or 40% or more over a rolling three-year period, manufacturers must flag it. They must submit a report within 30 days of the effective date explaining the exact factors driving the increase.
  • Targeted Deep Dives: Every year by June 1, the newly formed board will select up to 10 high-spend prescription drugs to undergo an intensive review, requiring manufacturers to hand over specific company-level R&D and capital expenditure data.
  • Public Transparency Webpage: The state will host a consumer-facing webpage featuring a prominent, dedicated link on the Department of Insurance homepage to display public prescription drug pricing data.

Compare & Contrast: Louisiana vs. Texas (HB 1033)When comparing Louisiana's SB 401 to Texas’s drug transparency law, the text reveals a few identical mechanisms alongside completely different enforcement philosophies.

The Similarities
  • Identical Triggers & Timelines: Both states utilize the exact same mathematical benchmarks for price increases (15% in one year / 40% over three years for drugs over $100).
  • Submission Deadlines: Both Louisiana and Texas set their annual WAC report deadlines for January 15.
  • Penalties: Both states enforce compliance via an administrative penalty of up to $1,000 per day for each violation.
  • Brands and Generics: Both states include reporting requirements for both brands and generic drugs.
  • Who is Required to Report: Louisiana and Texas law both cast a wide net across the supply chain, requiring annual transparency reports from Pharmacy Benefit Managers (PBMs) and health benefit plan issuers regarding aggregated rebates and spending metrics (in addition to these requirements on the manufacturers).

The Differences
  • The Oversight Body: Louisiana creates a dedicated, multi-member Prescription Drug Affordability Board tasked with actively analyzing drug classes and recommending cost-containment measures. Texas relies on its standard health department structure without a specialized board.
  • Targeted Audits: Louisiana's board proactively isolates 10 high-impact drugs per year for detailed financial scrutiny. Texas lacks this targeted "top 10" auditing mandate.
  • Administrative Fees: Texas requires manufacturers to submit an administrative fee (capped at $400) with their reports to fund the program. Louisiana's text does not outline an upfront filing fee for its submissions.

How SB 401 Impacts Current Louisiana Reporting

Louisiana has previously adjusted its laws surrounding drug costs, but SB 401 completely modernizes the state's approach by shifting from passive data collection to active, centralized accountability.

While older laws or historical quarterly WAC tracking focused primarily on static price logs, SB 401 introduces a multi-layered oversight system. It adds teeth to the state's regulatory framework by establishing a dedicated board to investigate the underlying "drivers" of those costs, launching an open-access public webpage for consumer awareness, and imposing strict 30-day notice requirements on triggering price increases.

Importantly, Section 3 of the new act explicitly cleans up the statutory books by repealing R.S. 22:1870(B)(5) to make way for this robust new standard. This is significant because in addition to creating a different price increase requirement, effective January 1, 2027, it ELIMINATES the requirement to provide a new drug notice to the state when introducing a new drug for distribution in this state when the wholesale acquisition cost is greater than the amount that causes the drug to be considered a specialty drug under the Medicare Part D program. Although the new drug notification requirement was proposed in earlier versions of SB 401, Senate Bill 368 would have preserved a new-drug-style reporting trigger but it remained pending in Senate Insurance and did not pass. Therefore, currently it does not appear that a new drug notice requirement will be in effect after January 1, 2027.

A Critical Compliance Note for 2027

With the law officially taking effect on January 1, 2027, manufacturers face an immediate compliance gray area. Companies will need to determine exactly how the annual reports due after that date must incorporate or disclose significant price increases that were taken prior to the law's effective date. Manufacturers should watch for Louisiana Department of Insurance rulemaking/guidance on the first January 15 annual WAC report.]]><![CDATA[SPTR UPDATE (5/26/2026)]]>Tue, 26 May 2026 14:41:29 GMThttps://www.glocomstrategies.com/blog/sptr-update-5262026With many state legislative sessions wrapping up in the coming weeks, we wanted to provide an update on some notable legislative activity in 2026 that we have been tracking over the last few months.

In short, several key Prescription Drug Affordability Board (PDAB) proposals have recently failed, including a governor veto alongside some bills which died in committee; however, some PDAB/transparency legislation remains actively moving through state legislatures, while similar measures in several other states remain pending or stalled as their respective legislative sessions wind down. Nonetheless, a recent judicial update is likely to spur new and enhanced state requirements.

Below are some notable updates:

  • Oregon PDAB given expanded capabilities
In April 2026, Oregon updated its PDAB's capabilities by amending the PDAB's drug selection process. The amendment also expands the affordability review criteria, adding new considerations such as whether a drug has contributed to health inequities in communities of color.

  • Illinois PDAB likely to be enacted
This bill (originally passed in the Senate and then passed in the House on May 21, 2026) is back in the Senate for a concurrence vote on a recent House amendment. With the legislative session adjourning on May 31, it is highly likely to reach the governor's desk, though Governor Pritzker has not yet guaranteed a signature. If enacted, this PDAB would be another example of a PDAB authorized to set upper payment limits for prescription drugs.

  • Virginia PDAB (Prescription Drug Affordability Board) bill vetoed by Governor
On May 19, 2026, Gov. Abigail Spanberger vetoed legislation that would have created a state board to review prescription drug costs, saying that evidence from other states shows that such boards do not achieve the goal of lower prices.

  • Bills penalizing "unsupported" or "excessive" price increases
An interestingly novel bill in Rhode Island, if enacted, would penalize pharmaceutical manufacturers for taking an "unsupported price increase" (i.e., an increase in which there was as no, or inadequate, new clinical evidence to support the price increase). To determine this, the state would rely upon analyses prepared by the Institute for Clinical and Economic Review (ICER) annual report.

The penalty in any calendar year would equal 80% of the difference between the revenue generated by sales within the state of the identified drug and the revenue that would have been generated if the manufacturer had maintained the WAC from the previous calendar year (adjusted for inflation).

Similarly, a New Jersey bill attempts to directly penalize manufacturers if a drug's WAC increases by 50% or more in a single year.

However, based on current progress, it is unlikely that either of these bills will be passed in their current form.

  • Judicial update expected to further state regulation
On May 18, 2026, the U.S. Supreme Court formally declined to hear multiple pharmaceutical industry challenges to the federal Medicare Drug Price Negotiation Program. By leaving lower court rulings intact, the Supreme Court has effectively signaled a reluctance to invalidate government-negotiated drug pricing frameworks. Legal analysts note this is expected to embolden state legislatures to aggressively pursue their own PDABs and upper payment limits with less fear of constitutional challenges.

]]><![CDATA[Download our PDAB Summary]]>Tue, 25 Feb 2025 15:03:36 GMThttps://www.glocomstrategies.com/blog/download-our-pdab-summaryWe recently presented on a hot-button topic in the world of drug pricing, "Prescription Drug Affordability Boards (PDABs): Overview, Challenges, and Recommend Strategies."  This presentation provides an informative overview for pharmaceutical manufacturers by covering the following aspects:
  • The reasons why there so many PDABs being established
  • The current PDAB landscape in the US
  • PDAB authority & tools
  • Pharmaceutical Manufacturer burdens
  • Legal Challenges
  • Example of affordability reviews and consequences
  • Interactions of Federal and State Controls
  • Next steps: What manufacturers need to think about

If you are interested in receiving a copy of the presentation, please enter your information in the contact form below and we will automatically provide you with a copy.
]]><![CDATA[Biohaven Settlement Includes Open Payments Violations]]>Tue, 28 Jan 2025 15:09:59 GMThttps://www.glocomstrategies.com/blog/biohaven-settlement-includes-open-payments-violationsAs reported by PolicyMed, Biohaven, a Pfizer subsidiary, recently resolved a settlement with the Department of Justice (DOJ) for nearly $60 million.  While the settlement resolved allegations of false claims related to improper physician remuneration for speaker programs, notably the case also highlighted violations of the Open Payments law for the failure to report speaker payments to CMS.

In the legal complaint, the Department of Justice stated that "Biohaven now attempts to hide the number and payments it made to speakers to cover up its quid pro quo activities. Biohaven is required by federal law to report all payments made to prescribers for the entire year in the first reporting period the following year.  Notwithstanding the actual data contained in Biohaven’s internal documents, the Company reported to CMS only approximately ten percent of the payments made to each of the speakers in order to prolong its scheme."

The significance of this claim is two-fold.  First, the DOJ used Biohaven's apparent failure to report accurately under the Open Payments law as evidence that Biohaven attempted to hide illegal arrangements with HCPs, bolstering the DOJ's false claims allegations.  Second, the failure to report likely allowed the DOJ to negotiate a larger settlement against Biohaven in light of civil monetary penalties that can be levied under the Open Payments law for failure to report accurately.

This case is yet another example of the government using Open Payments data (or the lack thereof) to strengthen the case for enforcement against life sciences manufacturers - not to mention imposing millions of dollars more in settlement amounts.  With the CY2024 report deadlines fast approaching, it also underscores the need for accurate and complete reporting under state and federal spend transparency laws, as well as the importance of viewing the data through a compliance lens prior to reporting.]]><![CDATA[NJ SPTR Registration Is Open]]>Thu, 23 Jan 2025 01:50:10 GMThttps://www.glocomstrategies.com/blog/nj_sptr_regOn Tuesday, January 21, 2025, the Garden State officially opened the registration process for its State Price Transparency Reporting (SPTR) program.  This means that drug manufacturers who meet the reporting criteria must now register with the Drug Affordability Unity at the NJ Division of Consumer Affairs and prepare to comply with the state's drug price transparency requirements.

All reporting entities - including drug manufacturers - have a short window to register; registration is required by January 31, 2025.

To register, manufacturers must use the Excel spreadsheet template provided.  For additional guidance, you may refer to the Data Collection Manual.  While not explicitly stated in the Manual, it appears that the "entity type" for drug manufacturers should be: "Manufacturer."  Moreover, it appears that completed registration forms should be emailed to: dau@dca.njoag.gov.

As a reminder, in NJ, reporting of applicable price increases and new drugs already went into effect on August 1, 2024.

To visit the NJ registration page for more info, please see here.]]><![CDATA[New Year, New Drug Price Reporting Bills]]>Sat, 04 Jan 2025 00:57:28 GMThttps://www.glocomstrategies.com/blog/new-year-new-drug-price-reporting-bills2024 was a record-setting year for new State Drug Price Transparency Reporting (SPTR) requirements.  From California to New Jersey, North Dakota to Texas, Maine to New Mexico, Washington to Florida, we've seen new SPTR laws enacted in every area of the country and across the political spectrum.

But brace yourselves because 2025 is picking up right where we left off.  In fact, while we are just a few days into the new year, we already have one of our first bills in New York that is proposing new SPTR requirements (in addition to the NY law that was already enacted last year)!

Already managing perpetual SPTR requirements in 15+ states with 30+ price increase calculations (not to mention new drug notifications and similar reporting ) is enough to make your head spin.  To alleviate this burden and help avoid potential regulatory scrutiny by exceeding price increase thresholds (not to mention severe enforcement penalties which have already been levied against the industry), our clients have trusted our cost-effective reporting services and first-of-its-kind software platform, Rx Price Transparency Tracker, which provides instant analysis on drug pricing considerations and their regulatory impact.

We've started this blog to help keep the industry informed of SPTR (and Spend Transparency) reporting requirements.

Keep checking back for more updates.  In the meantime, we hope you had no issues submitting the Louisiana SPTR report and have submitted or are about to submit the other January SPTR reports, such as North Dakota, Texas, West Virginia, Maine, Pennsylvania, and California.  Good luck!]]>