Winter 2024-25

Drug Pricing Legislation and Its Impact on Workers' Comp

Fast Focus

In an effort to combat high prescription drug costs for consumers, lawmakers look to regulate the U.S. drug supply chain in ways that could impact workers’ comp pharmacy management.

High prescription drug prices have concerned American consumers, and therefore American lawmakers, for decades. And there is good reason for those concerns. Prescription drug prices in the U.S. are almost three times higher than in other countries,1 and the average manufacturer drug price increase from 2022-23 was over 15%.2  Since 1980, U.S. spending on prescription drugs increased from $30 billion to $435 billion in 2023,3 although the total spend accounts for an increase in utilization, as well as prices.

This is in contrast to workers’ compensation,  where drug spending has been trending downward for more than a decade, mainly due to a combination of clinical and cost management strategies.4  The bulk of prescription drugs are purchased under group health insurance, including government and commercial plans, and both drug prices and utilization are on the rise for this sector.5 Their members, also known as healthcare consumers are directly impacted by high drug prices, and 82% of them say prescription drugs cost too much.6

Rx drug costs and utilization are trending up in group health and down in workers’ compensation

In response to consumers’ (also known as constituents) concerns, lawmakers have attempted to address the drug price issue in various ways.  These efforts have historically been – and still are – motivated by the desire to reduce costs for individual patients, focusing on the way drugs are paid for under Medicare and commercial health plans.

“The nuances of workers’ compensation healthcare delivery are often overlooked when these new laws are proposed and enacted,” said Sandy Shtab, VP, Industry and State Affairs for Healthesystems. “Unfortunately, workers’ comp pharmacy management is impacted just the same, sometimes in negative ways.”  

Legislative activity has been ongoing at both the federal and state levels, as outlined below, but the majority of laws that impact workers’ compensation are state laws.

Federal Legislation

Federal lawmakers have made sporadic efforts to pass legislation aimed at containing costs for their constituents. These efforts have taken many forms, but historically, few laws have been enacted and even fewer have impacted drug prices.

One notable exception was the Hatch-Waxman Act of 1984, which created the Abbreviated New Drug Application process that allowed generic drugs to gain FDA approval more quickly, catalyzing the generic drug market, which now accounts for over 85 percent of prescription drugs sold.  Generic drug prices are typically 80 percent lower than brand drug prices7, and this law truly did make most prescription drugs more affordable.

Another federal law, the Medicare Prescription Drug Improvement and Modernization Act (MMA) signed into law in 2003, ushered in Medicare Part D (implemented on January 1, 2006) to make medications more affordable for Medicare beneficiaries. While effective in its mission, MMA merely shifted the cost of prescription drugs from Medicare consumers to the federal government, without decreasing market prices.

More recently, the Inflation Reduction Act, signed into law on August 16, 2022, contains multiple provisions that are also intended to lower prescription drug costs for Medicare beneficiaries but through different methodologies than MMA, including negotiating prices and requiring rebates for some drugs if price hikes exceed the rate of inflation.8 Medicare accounts for over 20 percent of U.S. healthcare spending, 7 and Medicare prices are often used as benchmarks by other healthcare payers, so this downward pressure on drug prices may have a ripple effect that will reduce prices for certain drugs across the board. The Inflation Reduction Act is being phased in over a period of several years, however, so its impact on the prescription drug market remains to be seen.

Federal policy debates regarding prescription drug costs continue. Currently, attention is largely focused on regulating pharmacy benefit managers (PBMs). Twenty-six bills have been introduced in the 2023-24 session, but, as of this writing, only one bill was passed by the House, none have been passed by the Senate, and progress is slow.

State Legislation

State lawmakers have been more active than their federal counterparts, with a rash of bills aimed at reining in drug costs in recent years. Since 2017, 347 bills intended to curb prescription drug prices have been passed across all 50 states. As of August 2024, 402 state bills addressing various aspects of the prescription drug market were proposed, pending, or passed.9 The 2024 bills range in focus from expanded reporting requirements to limiting health plan member co-pays, establishing prescription drug advisory boards to capping manufacturer and distributor prices. The largest portion (43%) of bills are intended to regulate PBM operations.

State Drug Price Legislation Types 2024

The National Academy for State Health Policy9, which tracks and reports on all healthcare related bills, organizes drug pricing bills into 10 categories: 

Affordability review

Most of these bills seek to establish and direct a Prescription Drug Affordability Board (PDAB) or other advisory board to review prescription drug prices, explore strategies, and advise government officials on policies to make drugs more affordable.

Consumer cost sharing

These measures address consumer co-pays and set various restrictions on health plans and their PBMs regarding member cost sharing, including how co-pays are calculated and applied.

Importation

Bills allowing prescription drugs to be imported into the state from Canada.

Out of pocket caps

Most of these bills are specific to insulin and a few other drugs and specify a limited dollar amount that consumers can be required to pay for that drug.

PBM

The largest number of bills (171 bills or 43% of total) are intended to regulate a wide range of PBM operations. These include, but are not limited to, pharmaceutical manufacturer rebates and how to apply them; payments to and contractual terms with pharmacies; pharmacy network management; formularies and generic substitutions; reporting and licensing requirements.

Price gouging

These bills target pharmaceutical manufacturers and distributors with the intention of prohibiting unjustifiably high prices.

Reference rates

These measures establish official reference rates, or prices, for some or all prescription drugs sold in the state based on varying formulas.

Transparency

These bills vary in pertaining to manufacturers and wholesalers, health plans, PBMs, or government agencies within the relevant state. Generally, they require visibility into prices and price changes through specific reporting requirements.

Unsupported price hikes

The smallest number of drug pricing bills in 2024 target pharmaceutical manufacturers in efforts to discourage or prohibit large price increases, as defined by the state in question.

Other

The miscellaneous bills in this category cover some of the same ground as the defined categories, as well as budget appropriations and internal agency directives.

Many of the 402 state bills related to drug pricing are similar and/or overlap, even within individual states, and it is hard to predict which will become law. Current trends indicate that laws intended to regulate PBMs and insurers have the most support among state lawmakers, while laws that would regulate pharmaceutical manufacturers’ prices have the least. This is partly because the primary goal is to reduce prescription drug costs for consumers, as opposed to driving down prices for commercial insurers or government payer programs.

Designed for Group Health

Almost 70% of the $4.5 trillion of national healthcare spending takes place under group health plans, and the portion of that spend that went to prescription drugs in 2022 was $405 billion. By comparison, workers’ compensation total medical spend was $37.6 billion in 202210 with less than $3 billion (approximately 7%) spent on prescription drugs.11 Legislators naturally focus on the largest dollar amounts, so most of the current drug-pricing bills are written with group health insurers and their PBMs in mind.

2022 National Healthcare Spend Distribution

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The vast majority of prescription drug spend is processed through PBMs contracted with health plans. This is because these plans provide comprehensive health benefit coverages for the majority of patient populations, inclusive of most diseases and disorders, injuries and illnesses. This is in contrast to workers’ compensation coverage,  which are limited to treatment for a defined set of compensable injuries and occupational diseases.

As with most consumer goods, a number of entities are involved in the prescription drug lifecycle, including manufacturers, wholesalers, insurers, PBMs, and pharmacies, and each of these entities play an important role in providing needed drugs to patients. So, it’s debatable whether bills to exclusively regulate insurers and their PBMs will reduce drug prices, but there is no question that most of the current drug pricing legislation is directed at group health insurers and PBMs. This is evident in the language and provisions contained in many of the bills, such as measures to limit or reduce member co-pays and requiring that manufacturer rebates be credited to the price of drugs at the point of care. However, newly enacted laws can and do impact entities beyond their intended targets.  

Portion of $100 Rx drug cost

retained by each major drug supply chain entity13:

U.S. Retail Drug Distribution System

Impact on Workers’ Compensation

Eligible injured worker patients are entitled to all reasonable and necessary medical care, including medications with no out of pocket expense. Because medications are fully covered by  workers’ compensation insurers, regulations that address member or consumer costs simply do not apply. But most of these bills do not specifically exclude workers’ compensation coverages, which means that sometimes laws pertaining to insurers and PBMs also can unintentionally apply to workers’ compensation drug benefits. So, any new laws and regulatory requirements that are enacted have the potential to impact prescription workers’ compensation pharmacy program prices and operations.

Drug Pricing Legislation Impacting Workers’ Compensation

Bans on spread pricing

Requires that PBMs pay pharmacies the same amount for each drug as they charge their payer customers, also known as pass-through pricing, allowing no margin in the price. PBMs may charge a transaction fee on each prescription as a way to cover costs
Potential Impact:
A shift from simple discount pricing models to a drug cost price plus a higher transaction fee to cover costs for clinical services, technology, customer support, etc.

Minimum pharmacy payment requirements

Specify minimum price levels that PBMs can pay pharmacies for drugs.
Potential Impact:
Establishing a payment “floor” can interfere with competition in the marketplace and protect some retail pharmacies without enriching injured worker care or passing on savings to the insurer.

Pass-through rebates

100% of rebates paid by pharmaceutical manufacturers to PBMs must be credited back to the insurer. Some bills also require that the insurer must credit rebates back to their customers.
Potential Impact:
Rebates are paid long after the service is rendered, which would require refunds to claim files after the fact and could adversely impact claim reserving and closure activities for workers’ comp insurers.

Limits on in-network requirements

Prohibit insurers and PBMs from requiring that covered patients use in-network pharmacy providers and/or reimbursing out-of-network pharmacies at lower rates than in-network pharmacies.
Potential Impact:
Out-of-network providers are not bound by contractual agreements and can charge higher prices, which will be absorbed by payers.

Physician dispensing

Stipulate that PBMs may not prohibit or discourage physician dispensing of drugs.
Potential Impact:
Prices for physician dispensed drugs are usually much higher than retail pharmacy dispensed drugs and these costs will have to be covered by payers. 

Mail order pharmacy

Disallow the requiring of mail order fulfillment for prescriptions, specifying that patients cannot be required to receive their medications through mail order or required to pay more if they choose to use a local pharmacy rather than mail order.
Potential Impact:
Mail order requirements are not common in workers’ comp and injured worker patients do not pay for their prescriptions, so provisions such as this will only have an impact if price parity between mail order and retail is also required for payers. 

Transparency

Visibility into drug pricing practices is good for payers who need to understand all aspects of their pharmacy program economics.
Potential Impact:
However, price transparency does not directly regulate or reduce drug prices, and these laws may increase the administrative burden of state reporting requirements for insurers.

Since 2017, 177 laws pertaining to PBM operations have been passed,9  but few of them pertain directly to pricing. While almost all states are considering various pricing measures that target PBMs and insurers, 11 states have enacted pass-through pricing laws. In some states, these and other drug pricing bills conflict with the state’s workers’ compensation regulations, so remedies such as excluding workers’ compensation insurers and PBMs must be considered. 

To date, the impact of these legislative approaches on drug prices is uncertain, having thus far produced no evidence that they have lowered drug costs for consumers. Many state legislatures, however,  continue to propose and adopt similar law changes.

“State and federal lawmakers are focused on regulating PBMs whose influence on prescription drug prices has been greatly exaggerated,” said Shtab. “The degree to which these laws will lower drug prices is minimal, at best. Sadly, the  unintended result has been an increased administrative burden  on PBMs and the government agencies who regulate them., without any corollary benefit to the patients we serve. This increased burden also places pressure on PBMs and could ultimately result in changes to how certain complimentary services , like clinical management and regulatory compliance, are offered to workers’ compensation payers.”

States with Laws Regulating PBM Spread Pricing

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Price vs. Cost

Overall, prescription drug expenditures in the U.S. are significantly higher than in comparable nations and have continued to increase in recent years. Ironically, this is not the case in workers’ compensation where drug costs per claim have decreased by 24% since 2012.14 Prices did increase for the drugs commonly used in workers’ comp by an annual rate of 3.7% during this period, but total costs decreased, mainly due to utilization management.

Workers’ compensation drug costs per claim have decreased 24% since 2012

Price is obviously a crucial component in total drug costs, but quantity and selection of drugs being prescribed and dispensed is at least as important. Together, managed care organizations, including insurance carriers, TPAs, and PBMs, have reduced workers’ compensation costs through rigorous drug utilization management, which should be considered when weighing the potential benefits and consequences of pending legislation.

References

  1. Mulachy, Andrew, et. al. International Prescription Drug Price Comparisons. Rand Corporation. 2024. RAND_RRA788-3 (1).pdfhttps://aspe.hhs.gov/reports/changes-list-prices-prescription-drugs#:~:text=For%20those%20drugs%20with%20a,and%202022%20of%2011.5%20percent.
  2. Bosworth, Arielle, et. al. Changes in the List Prices of Prescription Drugs, 2017-2023. October 6, 2023. Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. https://aspe.hhs.gov/reports/changes-list-prices-prescription-drugs#:~:text=For%20those%20drugs%20with%20a,and%202022%20of%2011.5%20percent
  3. The IQVIA Institute for Human Data Science. The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028 May 7, 2024. IQVIA. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-use-of-medicines-in-the-us-2024
  4. Raji, H. et. al. Inflation and Workers’ Compensation Medical Costs Part 4: Prescription Drugs. March 28, 2023. NCCI. https://www.ncci.com/Articles/Pages/Insights-Inflation-WorkersComp-Medical-Costs-Prescription-Drugs.aspx
  5. Sonal, P. and Murphy, S. Trends in Prescription Drug Spending, 2016 – 2021. September 30, 2022. ASPE, Department of Health and Human Services. https://aspe.hhs.gov/sites/default/files/documents/a3849b001cb2b9b961a3b8399ddbfe23/sdp-trends-prescription-drug-spending.pdf
  6. Krinzinger, Ashley, et. al. Public Opinion on Prescription Drugs and Their Prices. Kaiser Family Foundation. August 21, 2023. https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and-their-prices/
  7. Federal Trade Commission Consumer Advice. How to Get Generic Drugs and Low-Cost Prescriptions. October 2023 Federal Trade Commission. https://consumer.ftc.gov/articles/generic-drugs-low-cost-prescriptions#:~:text=Generics%20have%20the%20same%20active,to%20your%20doctor%20and%20pharmacist.
  8. Cubanski, Juliette, et. al. Explaining the Prescription Drug Provisions in the Inflation Reduction Act. January 24, 2023. Kaiser Family Foundation. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/
  9. National Academy for State Health Policy. 2024 State Legislation to Lower Prescription Drug Costs. July 19, 2024. NASHP. https://nashp.org/state-tracker/2024-state-legislation-to-lower-pharmaceutical-costs/
  10. NSC Injury Costs. Work Injury Costs. 2024. National Safety Council. https://injuryfacts.nsc.org/work/costs/work-injury-costs/#:~:text=This%20figure%20includes%20wage%20and,worker%20in%202022%20was%20$1%2C040
  11. Cooper, Stephen. Medical Inflation Insights – July 2024. July 25, 2024. NCCI. https://www.ncci.com/Articles/Pages/Insights-medical-inflation.aspx
  12. Centers for Medicare and Medicaid. National Health Expenditure Data: NHE Fact Sheet. June 12, 2024. CMS Data & Research. https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet#:~:text=Historical%20NHE%2C%202022%3A&text=Medicare%20spending%20grew%205.9%25%20to,21%20percent%20of%20total%20NHE.
  13. Neeraj Sood et.al. Flow of Money Through the Pharmaceutical Distribution System. 2017. es: USC Schaeffer. https://healthpolicy.usc.edu/research/flow-of-money-through-the-pharmaceutical-distribution-system/
  14. Chadarevian, Raji and Sinclair, Jon. Medical Cost Trends: What’s in the Mix? Annual Insights Symposium 2024. NCCI. https://www.ncci.com/Articles/Documents/AIS2024-Medical-Cost-Trends.pdf

RxInformer

Since 2010, the semi-annual RxInformer clinical journal has been a trusted source of timely information and guidance for workers’ comp payers on how best to manage the care of injured worker claimants and plan for the challenges that lay ahead. The publication is an important part of Healthesystems’ proactive approach to advocating for quality care of injured workers while managing the costs associated with treatment.
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