Supply vs Demand: Which States are Reaching their COVID-19 Vaccine Tipping Points?

Published: May 4, 2021

We recently estimated that the U.S. was close to its “COVID-19 vaccine tipping point” – that is, the point at which vaccine supply may start to outstrip demand.  We also noted that national averages may mask important differences by state. We therefore sought to understand where states fall along this spectrum; such differences are important for understanding how best to target efforts to increase vaccine coverage throughout the country.

To do so, we looked at the share of adults with at least one vaccine dose by state, daily rates of first doses administered (using a 7-day rolling average), and how this rate has changed in the last week (see methods). We were particularly interested in identifying states that may still have relatively low vaccine coverage (i.e., below 50% of adults 18 or older) coupled with evidence of a decline in the uptake of first doses, as these states may present the biggest challenges for achieving sufficient vaccine coverage in the U.S.

As of April 29, among the 50 states and DC, we find that:

The share of adults who had received at least one vaccine dose was 55% overall, and ranged significantly across the country from a low of 41% (Alabama) to a high of 74% (New Hampshire). In addition, there is evidence of a decline in the pace of new uptake in most states. The daily rate of first dose administration at the national level is 440 per 100,000, ranging from 136 per 100,000 (Mississippi) to 889 (Rhode Island). Most states (31 of 51) are vaccinating below the national rate, reflecting the fact that vaccination rates are generally higher in larger states (e.g., California). Furthermore, the rate of first dose administration per 100,000 in the last week dropped for the U.S. overall (-17%) and for almost every state (45 of 51) (see Table 1).

At the higher end of the vaccine coverage spectrum, more than 60% of the adult population has received at least one dose in 12 states. These states are primarily in the Northeast (8 of 12). Seven have vaccination coverage of at least 65% and all but 3 (New Hampshire, New Mexico, and Pennsylvania) are administering first doses at well above the U.S. rate. Eight of the 12 states have seen declines in first dose administration rates over the past week, suggesting that these states may be approaching or have reached demand saturation, albeit at relatively high vaccination coverage levels and rates of administration.

 

At the lower end of the vaccine coverage spectrum, less than 50% of the adult population has received at least one dose in 13 states, including 6 that are below 45%. Nine of these states are in the South and in all, the daily rate of first vaccination per 100,000 is below the national rate. Moreover, most are experiencing declines in the rate of first doses administered. This suggests that these states may not only be approaching or have reached their tipping points, they have done so at relatively low levels of vaccine coverage.

The remainder of the states, which fall in between these two extremes, are primarily in the Midwest and, to a lesser extent, the South and West. In about half of these states, between 55% and 60% of adults have received at least once dose. All but one experienced declines in the rate of first doses administered in the last week.

States that demonstrate a combination of low overall vaccination coverage along with slow and declining vaccine uptake raise the greatest concerns. There are the 13 states with less than 50% coverage with at least one dose, all of which are vaccinating their adult populations below the national rate. Twelve of these states also saw declines in the rate at which they were vaccinating adults over the past week. These include 3 states (Alabama, Louisiana, and Mississippi) with vaccination coverage at or below 42%, the lowest in the nation, each of which is vaccinating at about half the rate of the U.S. overall. These are the states that are potentially the greatest distance from reaching sufficient levels of vaccine coverage and might be at risk for future outbreaks if levels are not increased significantly.

Discussion

As with the U.S. overall, most states appear to be at or near their COVID-19 vaccine tipping points – the point at which their supply is outstripping demand.  While this may not be as big a concern for states that have already vaccinated large shares (> 60%) of their adult populations with at least one dose, about one in four states have not yet reached 50%, which is well below coverage levels likely to be needed to drive down the risk of outbreaks going forward. Furthermore, in these states, the pace of vaccination is below the national rate. The fact that most of these states are also seeing declines in the rate of first dose administration suggests that they will be important targets for focused efforts to generate increasing vaccine demand.

Methods

Vaccination data were obtained from Johns Hopkins University Centers for Civic Impact, which collects state-level vaccination data from both the Centers for Disease Control and Prevention (CDC) and state COVID-19 dashboards, and by the Pennsylvania Department of Health (Pennsylvania data do not include the city of Philadelphia). Adult population data (18 years and older) were obtained from the 2019 State Population by Characteristics from the U.S. Census Bureau. We calculated both the 7-day rolling average for first doses administered and the share of the adult population that has received at least one dose for each state and the U.S. overall (excluding territories and doses administered through federal facilities for the U.S. overall calculations). We used these rolling averages to calculate the rate at which states and the U.S. are administering first doses per 100,000 adults. Weekly changes in rates of first doses administered were calculated using the percentage change from the current rate (April 29, 2021) to the rate from 7 days prior. Finally, we categorized states by region using the 2010 U.S. Census Bureau Region and Divisions classifications.

News Release

KFF’s Kaiser Health News and Gray Television Partner to Examine the Drive Times and Roadblocks for Stroke Victims in Appalachia and the Mississippi Delta

Published: May 4, 2021

KHN and Gray Television’s InvestigateTV team joined forces to dig into the underlying reasons why strokes are a deadlier threat across most counties in Appalachia and the Mississippi Delta, rural regions that are characterized by high rates of poverty, vulnerable elderly populations, a shortage of medical providers and an epidemic of local hospital closures.

They found that large shares of the regions’ residents live more than 45 minutes from a hospital that is stroke-certified and able to provide the most advanced care. Routing patients from rural areas to the right level of care can be an intricate jigsaw puzzle. The closest hospital may not offer the full scope of stroke treatments, but hospitals with more advanced care could be hours away.

KHN and InvestigateTV teamed up on the story as part of Gray’s year-long effort — Bridging the Great Health Divide, which spotlights health issues that have historically plagued rural parts of Appalachia and the Delta.

The InvestigateTV story aired this week on 32 Gray stations in the Appalachian and Delta regions. A companion digital story appears on KHN.org, InvestigateTV.com and all Gray websites. KHN has plans to expand its reporting in the South and on rural health issues, and expects to partner with InvestigateTV on more stories in the coming months.

About KFF and KHN

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. Recent KHN investigations include a deep dive on the nation’s public health infrastructure, a year-long project examining health care worker deaths during the pandemic, and an ongoing crowd-sourced investigation into medical billing practices. For all recent KHN investigations, see https://kffhealthnews.org/news/tag/investigation/.

 About Gray Television and InvestigateTV Gray Television is a leading media company that owns and operates high-quality stations in 94 television markets. InvestigateTV is Gray Television’s national investigative team, delivering original, in-depth reporting for Gray stations from award-winning journalists around the U.S.

 

Potential Implications of Policy Changes in Medicaid Drug Purchasing

Authors: Rachel Dolan, Rachel Garfield, and Robin Rudowitz
Published: May 4, 2021

Executive Summary

Executive Summary

While prescription drug pricing was an issue at state and federal levels even prior to the COVID-19 pandemic, there may be increased attention to Medicaid prescription drug policies as states face fiscal pressures from the economic effects of the pandemic and as the federal government may seek spending offsets to upcoming legislation aimed to expand coverage.  Medicaid provides health coverage for millions of Americans, including many with substantial health needs who rely on Medicaid drug coverage both for acute problems and for managing ongoing chronic or disabling conditions. Though the pharmacy benefit is a state option, all states provide pharmacy benefit coverage. Due to federally required rebates (under the Medicaid Drug Rebate Program, or MDRP), Medicaid pays substantially lower net prices for drugs than Medicare or private insurers, but Medicaid must provide coverage for all approved drugs for manufacturers participating in the MDRP. Within federal guidelines, states have flexibility to administer the benefit with regard to pricing, utilization management and supplemental rebates.

Policies designed to generate federal or state savings are likely to have implications for and invoke behavioral responses from other entities including drug manufacturers, pharmacies, managed care organizations (MCOs) and pharmacy benefit managers (PBMs).  Because these policy changes do not affect federal rules limiting Medicaid cost-sharing to nominal amounts, we did not separately examine how each policy change would affect enrollee costs. This report examines how leading federal and state policy proposals that increase Medicaid drug rebates, increase price transparency, and target drug prices could affect these entities, which could influence debate over these proposals and what the effects would be (Figure 1).

Figure 1: Potential changes to Medicaid prescription drug purchasing.

Policy proposals to increase rebates reduce federal and/or state spending through lower net reimbursement to manufacturers. While Medicaid rebates already provide a significant offset to the program’s drug spending, several policy proposals aim to further increase drug rebates in Medicaid.  Changes to the statutory rebate require changes in federal legislation; however, states have flexibility to use supplemental rebates and decide whether benefits are delivered through MCOs or are carved-out.  Increased rebates under MDRP would lead to direct federal savings, though the effect on state spending is dependent on how the policy is structured. States efforts to increase supplemental rebate agreements generally aim to increase purchasing power or other leverage in negotiation with manufacturers. States may be able to pool purchasing power across or within states, but ability to increase supplemental rebates in the future is uncertain. States may also seek to carve out prescription drugs from MCO contracts to capture all supplemental rebates and concentrate negotiating power.

Lack of transparency through the prescription drug pricing process, both in general and specifically within Medicaid, has led to several proposed federal and state policy proposals that aim to provide accurate and public information on drug pricing.  Drug list prices affect not only the reimbursement paid to the pharmacy but also the rebates the Medicaid program receives.  While list prices are public, manufacturers do not provide public information on how they set list prices and historically have not been required to explain changes in a product’s list price. Price transparency policies aim to make pricing information public to identify cost drivers, provide evidence for policy makers, or sometimes apply pressure to get payers to lower prices. Such policies include efforts to ban or limit spread pricing by pharmacy benefit managers (PBMs), policies to make information about list prices more accessible and efforts to limit or monitor 340B programs. The estimated savings to federal and state governments from efforts to increase PBM transparency is uncertain because estimates of spread pricing or the effect of bans on it vary widely, making the scale of the cost savings to Medicaid difficult to predict. It is also difficult to predict how other price transparency changes would affect state or federal Medicaid drug spending. Early efforts in these areas have not yet reported their impact on prices or costs.

Several other policies under consideration directly target Medicaid drug prices or prices paid by other payers, which would affect Medicaid prices as well. Generally, proposals that reduce underlying drug prices will reduce federal and state spending and decrease manufacturer reimbursement overall. For example, policies to expand the number of drugs affected by price ceilings (state Maximum Allowable Cost, or SMAC) could lead states to pay less in drug reimbursement.  Medicaid’s rebate formula ensures that the program receives “best price,” but the best price provision is often cited by manufacturers and other stakeholders as a barrier to discounts and value-based contracts for other payers. Proposals to eliminate best price would generally increase federal and state costs and increase reimbursement for manufacturers. Proposals to import drugs from foreign markets as a way to lower drug prices for consumers and state governments have gained attention in recent years but are unlikely to have a substantial effect on Medicaid drug spending. Proposals that would allow the federal government to negotiate the price of prescription drugs on behalf of people enrolled in Medicare Part D drug plans would, in general, increase state Medicaid drug costs due to lower rebate payments but would decrease federal spending overall.

Changes to Medicaid prescription drug policies have implications for manufacturers, MCOs, PBMs and pharmacies. As part of the Medicaid pharmacy supply and payment chain, these entities may also see payment and revenue effects due to changes to Medicaid spending. State Medicaid programs increasingly have relied on MCOs and PBMs to help administer the pharmacy benefit, and arrangements between those entities, manufacturers and pharmacies may also be impacted by changes to Medicaid prescription drug policy. For example:

  • To mitigate lower reimbursement from increased rebates, manufacturers may alter other prices, such as launch prices. To the extent that changes affect both prices paid to pharmacies by state Medicaid programs and pharmacies’ costs to acquire the drug, net changes to pharmacies could be neutral. However, efforts to recoup lost profits or lost savings for MCOs through changes to dispensing fees could affect pharmacies.
  • In response to efforts to curb spread pricing, PBMs will still have incentives to negotiate discounts, so effects on manufacturers are unclear. Eliminating or limiting spread pricing could lead to increased reimbursement to pharmacies, depending on how PBMs change their negotiating tactics with pharmacies.
  • If statutory rebates are reduced, MCOs and PBMs may have a larger role to negotiate lower prices or rebates for certain drugs with manufacturers.
  • The impact of price ceilings (through state maximum allowable cost programs) on MCOs and PBMs depends on how proprietary prices currently paid by PBMs compare to state price ceilings. Price ceilings for Medicaid reimbursement to pharmacies for ingredient costs would not directly impact manufacturers unless pharmacies attempted to negotiate lower purchase prices from manufacturers or wholesalers in response to lower reimbursement.
  • Medicaid drug pricing policies also have implications for providers that participate in the 340B program. The ceiling price, the price paid by entities in the 340B program for prescription drugs, is currently tied to the Medicaid rebate calculation. In addition, changes to how states administer the pharmacy benefit, either through FFS or MCOs, may impact the rules for how 340B entities interact with the Medicaid program and their revenue.

Looking ahead, federal and state policymakers continue to show interest in proposals to lower prescription drug costs as the public remains concerned about high and rising drug prices. President Biden has voiced support for policy proposals related to Medicare drug price negotiation and drug inflation rebates, and Congress may look to enact drug pricing proposals that were voted on but not enacted into law in the previous session. In addition, drug pricing policies, including Medicaid proposals, that reduce federal spending may provide spending offsets for other legislative priorities. Assessment of the implications of these proposals for Medicaid, and the actors involved in state Medicaid drug policy, can help understand their potential direct and indirect effects.

Issue Brief

Introduction

Prescription drug spending has again returned to the policy agenda, with Congress and the Administration developing proposals to target drug prices. Though attention in current federal actions is largely focused on Medicare drug prices, federal legislation also has been recently introduced or enacted that would affect Medicaid prescription drug policy. In addition, some Medicaid drug pricing policies could be included in upcoming legislation that aims to expand coverage, particularly if the policies provide spending offsets. In response to increased spending on high-cost specialty drugs, the Medicaid and CHIP Payment and Access Commission (MACPAC) recently adopted policy recommendations to Congress related to the Medicaid drug benefit. While drug costs have been a focus for state Medicaid programs even before the COVID-19 fiscal crisis, there may be renewed state interest in examining policy options that would reduce Medicaid drug spending to address fiscal constraints and meet demands for other pandemic-related spending.  As of March 2021, 14 states had introduced 17 bills that included provisions related to Medicaid prescription drug costs, and states are also pursuing a range of administrative actions in this area.

Medicaid provides health coverage for millions of Americans, including many with substantial health needs who rely on Medicaid drug coverage both for acute problems and for managing ongoing chronic or disabling conditions. Though the pharmacy benefit is a state option, all states provide pharmacy benefit coverage. States administer the benefit in different ways within federal guidelines regarding, for example, pricing, utilization management, and rebates. Due to federally required rebates, Medicaid pays substantially lower net prices for drugs than Medicare or private insurers. After high rates of growth from 2014-16 due to specialty drug costs and coverage expansion under the Affordable Care Act (ACA), Medicaid drug spending growth slowed from 2017-2018; however, drug spending growth increased again in 2019, and policymakers remain concerned about Medicaid prescription drug spending as new, curative therapies enter the market.

Medicaid drug policy involves several entities with an interest in this issue: state and federal governments are payers, reimbursing pharmacies and (indirectly) manufacturers for the cost of drugs for beneficiaries; pharmacies purchase drugs from manufacturers or wholesalers, dispense drugs, and receive a dispensing fee and payment for the cost of the drug; manufacturers set prices for drugs and sell these to wholesalers or pharmacies; managed care organizations (MCOs) and pharmacy benefit managers (PBMs) play a role in negotiating prices and utilization management for drugs. Policies to target one component of this complex supply and payment chain are likely to have implications and invoke behavioral responses to changes throughout the system.

This brief examines how leading federal and state policy options related to changes in Medicaid Drug Rebate Program (MDRP), drug pricing, and payment and management of the Medicaid prescription drug would affect state and federal governments as well as private industry (including drug manufacturers, managed care organizations, and pharmacies). It discusses potential federal and state policy changes in three areas: policies that increase Medicaid drug rebates, policies that increase price transparency, and policies that target drug prices.1 

Effects of Policies to Increase Rebates

While Medicaid rebates already provide a significant offset to the program’s drug spending, several policy proposals aim to further increase drug rebates in Medicaid. The Medicaid Drug Rebate Program (MDRP), established under federal law, includes two main components: a rebate based on a percentage of average manufacturer price (AMP) or the largest “best price” discount provided to most private purchasers, and an inflationary component to account for price increases.2  States can negotiate rebates in addition to the statutory rebate, referred to as supplemental rebates, and often use placement on their preferred drug list (PDL) as leverage to do so. Manufacturer rebates accounted for 56% of gross Medicaid drug spending in 2019. 3  For certain brand name drugs, Medicaid rebates were higher— on average, statutory rebates were 77 percent of Medicaid retail price in 2017, with the inflationary rebate component accounting for about half of the total discount.4  Several policy approaches increase statutory rebates or state supplemental rebates even more. These specific policies differ in how they can be implemented (federal vs state policy change) and in some of the potential effects for stakeholders. However, in general, they would lead to savings for government buyers and lower reimbursement for manufacturers.

Policies to Increase Statutory Rebates

Policies to increase rebates under MDRP include a range of actions targeted to launch prices, high-cost specialty drugs, and loopholes and gaming. These policies aim to address several issues with MDRP. First, the MDRP formula does not explicitly address launch prices or currently high-priced drugs. Second, the rebate formula varies by type of drug, with a higher rebate for brand drugs than for generics, and thus enables some gaming or flexibility in how drugs are classified. The rebate calculations rely on the pricing information reported by manufacturers; misclassified drugs or inaccurate price information in these files affects the rebate calculation, and improving the accuracy of information would ensure appropriate rebates are paid and allow for penalties for reporting inaccurate information. Proposals to increase the statutory rebate include increasing the minimum rebate percentage based on launch price, increasing the minimum rebate for certain high-cost specialty drugs, increasing the inflationary rebate; implementing price enforcement mechanisms to improve accuracy of information used to calculate rebates; and closing loopholes that enable manufacturers to lower rebate obligations. These actions build on recent federal action that lifts the rebate cap (currently set at 100% of AMP until 2024). Such changes require Congressional action to amend federal Medicaid law.

Increases to statutory rebates reduce federal Medicaid spending through lower net reimbursement to manufacturers (Figure 2).  For example, the Congressional Budget Office (CBO) estimates that recent action to remove the cap on inflationary rebates will increase the amount of rebates that manufacturers pay Medicaid and would reduce federal spending in Medicaid by $14.5 billion over the 2021-2030 period.

Figure 2: Potential effects of changes to Medicaid prescription drug purchasing to increase rebates.

The effect of changes to MDRP on state spending is dependent on how the policy is structured. In general, states and the federal government share in rebates. However, increases in statutory rebates passed as part of the ACA specifically excluded states from receiving a share of the increased rebate.5  Thus, depending on the policy, states may not share in increases to statutory rebates. Increases in federal rebates also could lead to lower state supplemental rebates, as manufacturers may be less willing to offer additional rebates beyond MDRP. 6 , 7   State actions to negotiate or maintain supplemental rebates, discussed in detail below, could counter this effect.

It is highly unlikely, though possible, that some manufacturers would opt out of the MDRP due to very low net Medicaid reimbursement. Manufacturers must opt in or out of the MDRP for all of their products, not just one, and participation in MDRP also impacts eligibility for Medicare Part B reimbursement. A recent analysis of net prices in several government programs concluded that, though Medicaid net prices were close to zero for some drugs, manufacturers have calculated that the increased revenue from other payers offsets the loss in revenue from Medicaid.8 

Effects of changes to MDRP on drug prices or costs to other payers are dependent on manufacturer decisions and other payers’ negotiating power. For example, the 2010 Affordable Care Act (ACA) included an increase in the base MDRP rebate amount, and analysis at the time concluded that manufacturers would increase launch prices (but the policy would still generate overall savings for Medicaid). Past analysis also indicated that manufacturers may increase prices to other payers in response to increased statutory Medicaid rebates, though those purchasers may be able to offset these increases by negotiating discounts with manufacturers.9  Subsequent research has had mixed findings on how the increase in base rebate led to other pricing responses, and specific Medicaid rebate proposals could target other aspects of pricing such as launch price. Manufacturers maintain that policies to increase Medicaid rebates create incentives to raise prices and may shift costs to other payers.10 

Implications for MCOs and pharmacies of many proposals in this area are uncertain and depend on how a specific policy is structured. To the extent that changes affect both prices paid to pharmacies by state Medicaid programs and pharmacies’ costs to acquire the drug, net changes to pharmacies could be neutral. However, efforts to recoup lost profit or lost savings through changes to dispensing fees could affect pharmacies.

Policies to Increase Supplemental Rebates

States efforts to increase supplemental rebate agreements generally aim to increase purchasing power or other leverage in negotiation with manufacturers. State supplemental rebates account for a small share (6% in 2019)11  of total rebates collected in Medicaid, in part reflecting lower state negotiating power. States generally share savings from supplemental rebates with the federal government.  While approximately two-thirds of the states with supplemental rebate programs (30 of 46 states) have entered into multi-state purchasing pools to enhance their negotiating leverage and collections, other options to increase leverage include a national pool, intra-state (cross-agency) negotiation, or inclusion of drugs covered through Medicaid managed care. For example, California has announced plans to pool purchasing power across Medicaid and other agencies to receive higher discounts, and Louisiana has a supplemental rebate agreement that also ensures access for incarcerated individuals.12 ,13 

Other actions to increase supplemental rebates draw on states’ control of preferred drug lists (PDLs) or other utilization control measures. Since supplemental rebates are not included in the best price calculation that impacts manufacturer statutory rebate obligations, states may be able to negotiate supplemental rebates for high cost specialty drugs without manufacturer concern over system-wide effects on prices.  Some states have negotiated “value based payment” models that lead to higher supplemental rebates and predictability in spending.14   For example, Louisiana’s “subscription model” supplemental rebate agreement caps the state’s expenditures on the drug covered under the arrangement during the term of the agreement.15  Other proposals would use outcomes-based contracts, similar to those negotiated by Oklahoma.

Lastly, other proposals aim to increase state-negotiated supplemental rebates by extending them to all drugs or by adding an inflationary component to supplemental rebates (similar to the inflationary component of statutory rebates). However, state ability to negotiate supplemental rebates is hampered by manufacturer willingness to provide rebates beyond statutory rebates, particularly when Medicaid programs are required under the MDRP to cover all their drugs.

Supplemental rebates may lead to state savings, but it is unclear how much states can increase supplemental rebates to achieve substantial savings.  If states are able to pool purchasing power with other agencies, they could see state savings in other health spending programs (e.g., state employees, prisons, substance use programs, etc.). However, while state supplemental agreements may lower costs or allow predictability in costs, it is unclear how much states will be able to negotiate in light of recent changes to the statutory rebate. After growing at double digits in the early 2000s,16  state supplemental rebates were relatively flat or decreasing after the 2010 changes to the MDRP, perhaps reflecting manufacturer unwillingness to offer additional rebates within Medicaid. On the other hand, state supplemental rebates increased in 2018 and 201917 , perhaps reflecting successful strategies to procure targeted rebates on high cost drugs. The specifics of state supplemental agreements are generally proprietary, and it is difficult to know how much states save through a particular agreement.

Efforts that carve out prescription drugs from MCO contracts to capture all supplemental rebates and concentrate negotiating power may increase reliance on brand-name drugs over generics. A majority of states use comprehensive managed care arrangements that include prescription drugs as a covered benefit. States that move to carve out this benefit to increase state negotiating power may change drug utilization patterns. Generally, MCOs promote somewhat greater use of generic drugs than FFS Medicaid, but generics may not always be the lowest net cost drug due to the rebates Medicaid receives.18 ,19  An increase in use of brand drugs could lead to higher gross costs, but the state would see a corresponding increase in rebates, as rebates on brand drugs are proportionately higher than generic and sometimes lead to lower net costs.

Some state actions to capture additional supplemental rebates may carry new administrative costs. For example, state efforts to coordinate prescription drug purchasing across state agencies may require extensive planning and coordination costs.20  In addition, states may face additional administrative costs if they manage the pharmacy benefit rather than outsource management to MCOs, though loading fees to MCOs would also decline.

The impact of increased supplemental rebates on MCOs or PBMs depends on current state policy and the structure of the rebate agreement.  As part of a policy to increase supplemental rebates, states may require MCOs and PBMs to pass through supplemental rebates or may prohibit MCOs or PBMs from negotiating additional rebates at all. Reducing or eliminating rebates could lower profits for MCOs, depending on how those rebates are accounted for in capitation payments. Under carve-out arrangements, MCOs may experience increased costs due to coordination challenges with FFS or delays in accessing pharmacy data to manage enrollee health.  Because many MCOs outsource administration of the pharmacy benefit to PBMs, carving out also would lead to lower PBM revenue through loss of contracts. States may choose to contract with PBMs through FFS, but FFS payment policies may limit PBMs’ ability to use spread pricing.

If states carve out prescription drugs to increase leverage for supplemental rebates, reimbursement to pharmacies could change. Drugs provided through FFS arrangements must be reimbursed at actual acquisition cost (AAC), defined as the state Medicaid agencies’ determination of pharmacy providers’ actual prices paid to acquire drugs. MCOs are not required to base reimbursements on AAC and therefore a shift to FFS could increase or decrease payment, depending on how MCOs paid prior to the carve out.

Effects of Policies to Increase Transparency

Lack of transparency through the prescription drug pricing process, both in general and specifically within Medicaid, has led to several proposed policies that aim to provide accurate and public information on drug pricing. Medicaid payments for drugs are based on several drug pricing benchmarks or negotiated prices, some of which are known only to the parties involved in the transaction. In addition, manufacturers do not provide public information on how they set list prices, and specific rebate amounts are considered proprietary. Further, increased reliance on pharmacy benefit managers (PBMs) poses challenges to drug price transparency.21  The prices PBMs pay manufacturers and reimbursement they pay pharmacies are often unknown. These issues make understanding of actual costs and spending drivers a challenge. Policy approaches to address this challenge include limiting PBM spread pricing, increasing manufacturer transparency and changes to the 340B program (Figure 3). Policies to increase transparency may be implemented at the state or federal level, and the implications may differ based on how the policy is implemented.

Figure 3: Potential effects of transparency policies in Medicaid prescription drug policy.

Policies to Limit PBM Spread Pricing

Increased concern over spread pricing by pharmacy benefit managers (PBMs) has led to state and federal proposals or policies to limit or ban such practices. PBMs help administer drug benefits and take on financial responsibilities such as negotiating prescription drug rebates with manufacturers and dispensing fees with pharmacies. Spread pricing refers to the difference between the payment the PBM receives from the state or MCO and the reimbursement amount it pays to the pharmacy. States are increasingly taking action to monitor and regulate PBM spread pricing, with 15 states reporting laws in place or planned for 2019 and 2020. States can enact legislation banning spread pricing outright or placing other requirements on PBMs that contract with the Medicaid program. States also can place stipulations on contracts with MCOs to not contract with PBMs that use spread pricing. Other policy proposals to limit spread pricing include implementing reporting requirements on PBM reimbursement. The federal government also could enact legislation regulating PBMs more broadly by prohibiting or limiting spread pricing in the Medicaid program and has increasingly shown interest in oversight of PBMs.

Estimates of spread pricing or the effect of bans on it vary widely, making the scale of the cost savings to Medicaid difficult to predict. Overall, limiting spread pricing would likely decrease net federal and state spending through lower payments to MCOs or PBMs. If PBMs and MCOs were required to pass through any savings, states spending for prescription drugs could decline by the spread price amount. Further, the federal government may indirectly share in savings because Medicaid drug costs are jointly financed by state and federal funds. A number of states have conducted analyses finding high amounts of spread on generic drugs and estimating state savings in the millions if spread pricing is eliminated, but it is not clear to what extent these findings are generalizable to other states. An analysis by CBO of federal legislation to ban spread pricing estimated federal savings of $929 million nationwide between 2021-2030.

The overall effect of limiting PBM spread pricing on manufacturers is uncertain, as PBMs retain some incentives to negotiate discounts. PBMs generally use leverage and PDL management to negotiate lower prices from manufacturers and generally incentivize use of generic drugs.22  While PBMs would no longer retain these savings as spread pricing, they may still have an incentive to negotiate lower manufacturer prices due to the need to compete for contracts. Because research has shown that PBMs generate higher spread on generic drugs than brand drugs, elimination of spread pricing may mean PBMs may have less of an incentive to prioritize generic drugs.23 ,24 ,25  Manufacturers could see an increase in revenue due to increased brand drug usage but also would likely pay more in rebates to Medicaid.

Eliminating or limiting spread pricing could lead to increased reimbursement to pharmacies, depending on how PBMs change their negotiating tactics with pharmacies. PBMs often negotiate with pharmacies to create “network” pharmacies, driving business to pharmacies and allowing PBMs to negotiate lower payment rates to pharmacies (and thus increase their spread).  Pharmacy reimbursement to network pharmacies may increase without PBM incentive to create spread, and other pharmacies may see increased business due to decreased PBM incentives to create pharmacy networks.

Policies to Increase Manufacturer Price Transparency

A range of federal and state policy proposals aim to make information about list prices more accessible in an effort to curb drug costs. Drug list prices affect not only the reimbursement paid to the pharmacy but also the rebates the Medicaid program receives.  Manufacturers do not provide public information on how they set list prices and historically have not been required to explain changes in a product’s list price. Price transparency policies aim to make pricing information public to identify cost drivers, provide evidence for policy makers, or sometimes apply public pressure to get payers to lower prices.

Most action on manufacturer price transparency has been taken at the state level. State policies range from acquiring price information on all drugs to requiring reporting for drugs with high cost increase. The limits of state regulatory power over pharmaceutical companies are not clear, and manufacturers often challenge state laws in court.26  Federal policies related to price transparency include making National Average Drug Acquisition Cost (NADAC, a federal survey of pharmacies that helps states to determine pharmacy acquisition cost) mandatory and increasing the amount of information collected by the survey; requiring manufacturer reporting; and price transparency of Wholesale Average Cost (WAC) and Average Manufacturer Price (AMP). Some federal administrative actions (e.g., the Trump administration’s rule to require drug pricing in pharmaceutical television advertising) have been blocked in court,27  and legislative action may be needed to establish authority for some specific policies.

To date, the impact of transparency on actual prices is uncertain, making it difficult to predict changes to state or federal Medicaid drug spending. So far, most states with transparency or reporting laws are at the initial stages of reporting price data but have not reported impact on prices.  An analysis by CBO estimates no federal savings from price transparency provisions that would require manufacturers to justify price increases on certain drugs. However, to the extent that transparency allows policymakers to target cost-saving actions (for example, by placing caps on price increases), such policies could potentially lead to lower federal and state spending for Medicaid prescription drugs. Increased transparency around WAC and NADAC may allow states to more accurately reimburse pharmacies for acquisition costs. Transparency could also allow for better enforcement of the MDRP by increased accuracy of price reporting, which could reduce state and federal net drug spending by increasing rebate amounts.

The impact of transparency on manufacturers would depend on manufacturer behavior and response to reporting requirements.28  Reporting requirements could increase public pressure to lower prices for drugs subject to reporting or review, though it is not clear whether manufacturers would respond to this pressure. Transparency could also allow for better enforcement of the MDRP and increased state leverage in supplemental rebate negotiations, which would increase manufacturer payments to states and the federal government.

Increased price transparency may also limit PBM ability to use spread pricing, outside of efforts directly target spread pricing. If prices are publicly known or reported to state agencies, states may demand PBM pricing closer to actual costs.29 

Policies to Limit or Monitor the 340B Program

Concerns over program integrity of the 340B program, which provides discounted drugs to certain safety net providers, have led to proposed policy changes to limit the program or require additional oversight and reporting. As a condition of participation in the MDRP, manufacturers must also participate in the federal 340B program, which offers discounted drugs to certain safety net providers, known as covered entities (CEs), that serve vulnerable or underserved populations in order to maximize use of federal resources. CEs pay a deeply-discounted “ceiling price” to manufacturers for prescription drugs. The 340B program is administered separately from the MDRP, and federal law requires states and safety net providers to ensure that manufacturers do not pay duplicate discounts for Medicaid beneficiaries. States may set guidelines for CEs on whether or not to provide drugs purchased with the 340B program discounts to Medicaid beneficiaries.

The increased use of managed care in administering the pharmacy benefit has led to 340B transparency issues, as 340B drugs covered by MCOs are harder to track and exclude from Medicaid rebate requests.30  Similarly, increased use of contract pharmacies by CEs has made it more difficult to track 340B drugs and ensure duplicate discounts are not occurring.31  Recently, some manufacturers have announced that they will no longer provide discounts on drugs dispensed at 340B contract pharmacies,32  and there is increased attention to whether CEs are buying drugs at the discounted price and selling them at a higher price to Medicaid or other payers. Lastly, the number of covered entities and contract pharmacies has grown dramatically, but the federal government has conducted only limited audits of covered entities and has stated it does not have sufficient enforcement capabilities to ensure program compliance.33  Policies to address transparency in 340B include a moratorium on new CEs as well as increased oversight and reporting requirements. Like other transparency policies, the aim of many 340B efforts is to provide policymakers and others information to target overpayments (or, in this case, duplicate discounts). Others seek to extend 340B pricing, such as a rule finalized by the Trump administration in December 2020 that would have required CEs to pass through 340B pricing on certain drugs to low income people (the rule has been delayed by the Biden administration).

Changes to 340B will directly affect payments to manufacturers and costs paid by CEs. Manufacturers would potentially receive higher payments due to fewer duplicate discounts. Alternatively, manufacturers may pay more rebates to Medicaid programs for drugs dispensed to Medicaid beneficiaries outside of the 340B program, so the overall cost impact is uncertain. In general, 340B entities would see higher costs to acquire drugs. Additional reporting requirements may increase administrative burdens on smaller CEs, reducing their participation in the program.

Limits to the 340B program may result in some state and federal Medicaid savings. Medicaid payments to pharmacies reflect the acquisition cost of a drug plus a professional dispensing fee. For drugs provided to Medicaid beneficiaries through 340B, the acquisition cost reflects the ceiling price and may be lower than costs outside 340B; however, states forego rebates on 340B drugs. Elimination or limits on 340B would thus potentially increase state payments to pharmacies and increase rebates collected, leading to uncertain net effects on Medicaid costs. Other state savings could accrue if states were paying higher 340B dispensing fees (due to add-on fees paid to CEs) or are able to collect supplemental rebates on additional drugs due to increased negotiating power. The federal government would also share in any increased rebates, reducing net federal spending.

The effect of 340B changes on MCO, PBM and pharmacy reimbursement are dependent on a complex network of payment arrangements between these entities. MCO payments to pharmacies do not have to reflect acquisition costs for drugs, so it is unclear what effect limits to 340B will have on plan payments or costs.  Pharmacies that dispense 340B drugs may see lower dispensing fees if policies limit the 340B program because they will lose add-on fees that states pay specifically for CEs.34  In addition, limits to 340B that restrict the use of contract pharmacies (which may be retail pharmacies) may reduce revenue for these pharmacies.

Other Potential Effects of Medicaid Drug Policy Changes on the 340B Program35 

Other policies that impact Medicaid drug pricing may also have implications for 340B entities. Ceiling price, the price paid by entities in the 340B program for prescription drugs, is currently tied to the Medicaid rebate calculation. A change to the Medicaid rebate formula or inputs may impact the prices paid by 340B entities.36  Policies that impact underlying drug prices may also impact 340B reimbursement if the program’s discount is weakened.

In addition, changes to how states administer the pharmacy benefit may impact 340B entities. Some states have different rules for 340B for drug benefits provided through FFS and MCOs, including guidelines around contract pharmacies and carving in to Medicaid. Duplicate discounts are more prevalent in managed care due to administrative complexity and are easier to prevent when drugs are provided through FFS, so an increase in states carving out pharmacy from managed care may reduce revenue for CEs. States may also choose to carve the 340B program out of Medicaid to reduce coordination issues around duplicate discounts and to provide more leverage to the state in negotiations with drug manufacturers for supplemental rebates.

Effects of Policies to Address Drug Pricing

Several other policies under consideration directly target Medicaid drug prices or prices paid by other payers, which would affect Medicaid prices as well. Medicaid payments for prescription drugs are determined by a complex set of policies, at both the federal and state levels, that draw on price benchmarks linked to both drug list prices and acquisition costs for drugs. Because price benchmarks are related to one another, the prices paid throughout the drug distribution process have an effect on the final price that Medicaid pays. Both states and the federal government have price ceilings set for certain drugs, known as Federal Upper Limits (FULs) and Maximum Allowable Costs (MACs), and some proposals target these price ceilings. Others target Medicaid “best price,” largely to allow exceptions for other payers. Although not specifically targeted at Medicaid, policy approaches designed to change the structure of pricing for Medicare or private insurance—such as allowing drug importation or allowing Medicare to negotiate drug prices—also have implications for Medicaid. (Figure 4).

Figure 4: Potential effects of price policies in Medicaid prescription drug policy.

Policies to Expand State MAC Programs

Nearly all state Medicaid programs impose price ceilings (state Maximum Allowable Cost, or SMAC) on reimbursement for certain multiple-source (generic) drugs, and some state efforts expand MAC lists to include all generic drugs or apply to managed care. States do not buy drugs directly from manufacturers but instead reimburse pharmacies based on the ingredient cost of the drug, plus a professional dispensing fee. State MAC programs set limits on ingredient costs. They frequently include drugs that do not have established federal upper limits (FULs), which similarly set a federal price ceiling on certain multiple-source drugs.37  States set their own MAC lists for FFS drugs. Currently, MCOs and PBMs are not required to pay based on state MACs and often have their own proprietary MACs. Proposals to expand MAC include increasing the number of drugs on MAC lists as well as extending MAC pricing to MCOs.

In general, expansion of the number of drugs that SMAC applies to could lead states to pay less in drug reimbursement if state MACs for drugs are lower than other price benchmarks. Expanded MACs may reduce the “ingredient cost” portion of pharmacy reimbursement for some drugs depending on state formula. SMACs generally are part of a complex “lesser of” formula for ingredient costs, where the state agency sets reimbursement for multiple-source drugs at the lowest amount for each drug based on (1) the state’s AAC formula, (2) the FUL (if applicable), (3) the state MAC or (4) the pharmacy’s usual and customary charge to the public. Thus, if SMAC is below AAC, the state will have a lower payment amount for the drug. However, if states correspondingly increase pharmacy dispensing costs (as most did when moving to paying based on acquisition cost), much of those savings may be offset. To the extent that states realize savings from pharmacy reimbursement, the federal government would also share in those savings.

The impact of expanded MACs on MCOs and PBMs depends on how proprietary MACs currently paid by PBMs compare to state MACs. If state MACs are lower than current prices paid by MCOs and PBMs, MCO/PBM reimbursement costs would decrease, though states will also reduce capitation payments correspondingly. If state MACs are higher, it would increase payments by MCOs and PBMs to pharmacies. Universal use of MACs may also increase transparency, reducing the ability of PBMs to spread price.

Price ceilings for Medicaid reimbursement to pharmacies for ingredient costs would not directly impact manufacturers unless pharmacies attempted to negotiate lower purchase prices from manufacturers or wholesalers in response to lower reimbursement. To the extent that changes affect both prices paid to pharmacies by state Medicaid programs and pharmacies’ costs to acquire the drug, net changes to pharmacies could be neutral. States may also increase dispensing fee to account for the decrease in reimbursement, as states generally increased dispensing fees when Medicaid reimbursement rules changed.38 

Changes to Medicaid Best Price

Medicaid’s rebate formula ensures that the program receives “best price,” but the best price provision is often cited by manufacturers and other stakeholders as a barrier to discounts and value-based contracts for other payers. Under the MDRP, the rebate amount is a defined percent of Average Manufacturer Price (AMP) or the difference between AMP and “best price,” whichever is greater.39  Best price is defined as the lowest available price to any wholesaler, retailer, or provider, excluding certain government programs, such as the health program for veterans. The trend of new, high-cost therapies has created interest in value-based payment arrangements for specific drugs, but manufacturers may be unwilling to enter these agreements for fear of lowering the best price, which would then apply to Medicaid. Proposals to modify best price include allowing exceptions for value-based arrangements, entirely eliminating the best price provision (which may be offset by an increase in the minimum rebate amount) and setting uniform reporting rules for prices under value-based arrangements. Because best price is established under federal law, any changes to its calculation would require federal regulations or legislation.40  The Centers for Medicare and Medicaid Services (CMS) has recently finalized a rule making significant changes to best price reporting, including allowing multiple “best prices,” but the Biden Administration has yet to state its policy on the rule.

Proposals to eliminate best price would generally increase federal and state costs and increase reimbursement for manufacturers. In general, Medicaid rebates for brand name drugs are significantly higher than the minimum rebate amount, and brand drugs account for approximately 80% of gross Medicaid drug spending. Eliminating or modifying best price would reduce rebates closer to the minimum rebate amount and lower rebates received by state and federal government. It is unlikely that states could negotiate supplemental rebate agreements to make up for these lower rebates.41  Manufacturers also will have more flexibility to offer lower prices to different payers, which they would likely only do if their total revenue increased under the arrangement.

If statutory rebates are reduced, MCOs and PBMs may have a larger role to negotiate lower prices or rebates for certain drugs with manufacturers. Reimbursement effects depend on whether the MCO or PBM is required to pass through the additional rebates to the state. States may also carve out the pharmacy benefit or take other actions as described above to increase supplemental rebates in response to lower statutory rebates. These approaches could reduce MCO and PBM reimbursement; it is unlikely they would generate enough savings to offset the loss of best price.

It is not clear what effect changes to best price would have on pharmacy reimbursement. Best price and statutory rebates are separate from the prices paid by Medicaid to pharmacies, which are based on pharmacies’ acquisition costs. However, underlying manufacturer list prices do impact both best price and pharmacy reimbursement. State reimbursement to pharmacies would depend on manufacturer behavior and any price changes, as pharmacy reimbursed is based on the pharmacy’s cost to acquire the drugs.

Pricing Policies Focused on Other Payers

Proposals that would allow the federal government to negotiate the price of prescription drugs on behalf of people enrolled in Medicare Part D drug plans would, in general, increase state Medicaid drug costs due to lower rebate payments but would decrease federal spending overall. Due to rising drug prices and increased federal and beneficiary spending, there has been increased interest in allowing the government to negotiate drug prices for Medicare Part D, which is not allowed under current law. These proposals take varying approaches to how the negotiated prices would impact other programs and payers.  Proposals may narrowly focus price negotiation on prices paid by Medicare or extend the price to Medicaid and private insurance. Some proposals also include an additional penalty on drugs with prices rising faster than inflation, similar to the MDRP. A CBO analysis of a proposal to allow the federal government to negotiate drug prices for certain drugs on behalf of Medicare found that Medicaid inflation rebates would decrease and overall Medicaid drug spending would increase. If the negotiated price is extended to Medicaid, state costs could still increase unless there is a provision requiring a drug’s net price to be lower of either the rebate or the negotiated price. CBO also found that that federal spending would decrease significantly due to the large amount saved on Medicare drugs. Medicaid spending would increase as noted above but would be offset by a significant decrease in Medicare spending.

Proposals to import drugs from foreign markets as a way to lower drug prices for consumers have gained attention in recent years but are unlikely to have a substantial effect on Medicaid drug spending. In fall 2020, the Trump Administration issued a final rule and FDA guidance for industry creating new pathways for the safe importation of drugs from Canada and other countries by pharmacists, wholesales, states, and certain entities, subject to specified limitations and safeguards. The law requires importation to result in a significant reduction in drug costs and requires states to submit a plan for approval to the FDA. While some states have developed importation proposals, few have moved forward with implementation due to barriers related to regulation, safety and overall financial impact. In general, while a state may save money through importation, it would likely be through programs other than Medicaid. Due to the high rebate amounts Medicaid receives, unless states could claim rebates on top of lower imported prices, imported prices would likely not be lower than net Medicaid prices. State estimates of current proposals do not anticipate significant savings in Medicaid.

Looking Ahead

Prescription drug policy is likely to remain an issue at both the federal and state levels due to budgetary constraints and the entry of new, high-cost drugs. While federal and state policymakers remain focused on addressing the COVID-19 pandemic, the economic recession due to the pandemic and its impact on state budgets may lead to increased attention on reducing Medicaid prescription drug spending. President Biden has supported policies that would lower prescription drug costs for patients and has prioritized increasing access to affordable health coverage among his early executive actions.42  Congress has already started hearings on legislation to target drug prices and is expected to include such proposals in forthcoming reconciliation bills.

In a narrowly divided Congress, Medicaid prescription drug policies may provide spending offsets for reconciliation bills. In addition to policies directly impacting Medicaid, other drug pricing proposals to negotiate drug prices on behalf of Medicare or other payers would also have implications for Medicaid spending and beneficiary access. State policymakers also continue to be interested in reducing Medicaid drug spending. There may be challenges to implementation of Medicaid drug policy changes due to opposition from stakeholder groups. Proposals that produce federal and state savings due to reduced revenues for other actors such as manufacturers or PBMs, including increased rebates or limiting spread pricing, may face opposition from those groups. In the past, manufacturers and PBMs have challenged laws and other regulatory efforts in court. Assessment of the implications of these proposals for Medicaid, and the actors involved in state Medicaid drug policy, can help understand their potential direct and indirect effects, as well as the politics surrounding them.

This work was supported in part by Arnold Ventures. We value our funders. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.

Endnotes

  1. Because these policy changes do not affect federal rules limiting Medicaid cost-sharing to nominal amounts, we did not separately examine how each policy change would affect enrollee costs. ↩︎
  2. Best price only applies to brand drugs, generic drug rebates are 13% of AMP ↩︎
  3. MACPAC, Medicaid Drug Spending Trends, December 2020. Analysis of CMS State Drug Utilization Data https://www.macpac.gov/publication/medicaid-gross-spending-and-rebates-for-drugs-by-delivery-system/ ↩︎
  4. CBO analysis of 176 top-selling brand-name drugs in Medicare Part D. CBO computed the average price of those drugs per standardized prescription—a measure that roughly corresponds to a 30-day supply of medication. Congressional Budget Office, A Comparison of Brand-Name Drug Prices Among Selected Federal Programs (CBO, February 2021), https://www.cbo.gov/system/files/2021-02/56978-Drug-Prices.pdf ↩︎
  5. CMS, State Medicaid Director Letter #10-019, Medicaid Prescription Drugs, (September 2010) https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/smdl10019.pdf ↩︎
  6. State supplemental rebate agreements often decrease proportionally with federal rebate increases. Department of Health and Human Services Office Of Inspector General,  States’ Collection Of Offset And Supplemental Medicaid Rebates, (HHS 2014),  https://oig.hhs.gov/oei/reports/oei-03-12-00520.pdf; Congressional Research Service, Medicaid Prescription Drug Pricing and Policy (CRS 2014), https://www.everycrsreport.com/reports/R43778.html#_Ref395445519 ↩︎
  7. Congressional Budget Office, The Effect of the March Health Legislation on Prescription Drug Prices (CBO, November 2010), https://www.cbo.gov/sites/default/files/111th-congress-2009-2010/reports/11-04-drug_pricing.pdf ↩︎
  8. P. 19. Congressional Budget Office, A Comparison of Brand-Name Drug Prices Among Selected Federal Programs (CBO, February 2021), https://www.cbo.gov/system/files/2021-02/56978-Drug-Prices.pdf ↩︎
  9. CBO estimated that the increased Medicaid rebates in the ACA would lead to increased prices paid by retail pharmacies, but employer plans and others who negotiate with manufacturers would likely see no net increase. Congressional Budget Office, The Effect of the March Health Legislation on Prescription Drug Prices (CBO, November 2010), https://www.cbo.gov/sites/default/files/111th-congress-2009-2010/reports/11-04-drug_pricing.pdf ↩︎
  10. PhRMA, Comments Of The Pharmaceutical Research And Manufacturers Of America, (PhRMA 2018), https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-RFI-Comments-on-HHS-Blueprint-to-Lower-Drug-Prices-and-Reduce-Out-of-Pocket-Costs5.pdf ↩︎
  11. KFF analysis of Urban Institute estimates based on data from CMS (Form 64), as of August 2020. ↩︎
  12. Executive Order N-01-19, January 7, 2019. https://www.gov.ca.gov/wp-content/uploads/2019/01/EO-N-01-19-Attested-01.07.19.pdf ↩︎
  13. Horvath, Jane. State Initiatives Using Purchasing Power to Achieve Drug Cost Containment (NASHP 2019), https://www.nashp.org/wp-content/uploads/2019/04/Rx-Purchasing-Paper-Jane-Horvath-FINAL-4_9_2019.pdf ↩︎
  14. Gee, Rebecca. “Louisiana’s Journey Toward Eliminating Hepatitis C” Health Affairs Blog (April 2019). https://www.healthaffairs.org/do/10.1377/hblog20190327.603623/full/ ↩︎
  15. CMS, “CMS Approves Louisiana State Plan Amendment for Supplemental Rebate Agreements Using a Modified Subscription Model for Hepatitis C Therapies in Medicaid”, (June 2019). https://www.cms.gov/newsroom/press-releases/cms-approves-louisiana-state-plan-amendment-supplemental-rebate-agreements-using-modified ↩︎
  16. Average annual growth in state sidebar rebates from 2000-2010 was 21%. KFF analysis of Urban Institute estimates based on data from CMS (Form 64), as of August 2020. ↩︎
  17. Following average annual growth of -2% from 2010-2017, state sidebar rebates grew by 10% in 2018 and 19% in 2019. KFF analysis of Urban Institute estimates based on data from CMS (Form 64), as of August 2020. ↩︎
  18. Magellan Rx Management, Magellan Rx Management 2018 Medical Pharmacy Trend Report, (Magellan Rx Management, 2018), https://www1.magellanrx.com/documents/2019/03/medical-pharmacy-trend-report_2018.pdf/. ↩︎
  19. Magellan Rx Management, Magellan Rx Management 2020 Medicaid Pharmacy Trend Report, (Magellan Rx Management, 2020), https://issuu.com/magellanrx/docs/mtr20_final_v2?fr=sNTNiODE4MzMzMDk ↩︎
  20. Pamela Hyde, “State Mental Health Policy: A Unique Approach to Designing a Comprehensive Behavioral Health System in New Mexico.” Psychiatric Services (September 2004), https://ps.psychiatryonline.org/doi/10.1176/appi.ps.55.9.983 ↩︎
  21. 81 Federal Register 5169-5357, (February 1, 2016). ↩︎
  22. Inmaculada Hernandez and Walid Gellad, “Differences Between Managed Care and Fee-for-Service Medicaid in the Use of Generics for High-Rebate Drugs: The Cases of Insulin Glargine and Glatiramer,” Journal of Managed Care + Specialty Pharmacy (February 2020), https://www.jmcp.org/doi/10.18553/jmcp.2020.26.2.154 ↩︎
  23. Robert Langreth, David Ingold and Jackie Gu, The Secret Drug Pricing System Middlemen Use to Rake in Millions (Bloomberg 2018), https://www.bloomberg.com/graphics/2018-drug-spread-pricing/ ↩︎
  24. 46brooklyn, New drug pricing analysis reveals where PBMs and pharmacies make their money, https://www.46brooklyn.com/research/2019/4/21/new-pricing-data-reveals-where-pbms-and-pharmacies-make-their-money ↩︎
  25. CMS, CMS Issues New Guidance Addressing Spread Pricing in Medicaid, Ensures Pharmacy Benefit Managers are not Up-Charging Taxpayers, (CMS 2019), https://www.cms.gov/newsroom/press-releases/cms-issues-new-guidance-addressing-spread-pricing-medicaid-ensures-pharmacy-benefit-managers-are-not ↩︎
  26. Katherine L. Gudiksen, , Samuel M. Chang, and Jaime S. King, Navigating Legal Challenges to State Efforts to Control Drug Prices: PBM Regulation, Price Gouging, and Price Transparency, (NASHP 2019), https://www.nashp.org/legal-challenges-to-state-rx-laws/ ↩︎
  27. Allyn, Bobby, “Judge Blocks Trump Rule Requiring Pharma Companies To Disclose Drug Prices In TV Ads” (NPR, July 2019), https://www.npr.org/2019/07/09/739770699/judge-blocks-trump-rule-requiring-pharma-companies-to-say-price-of-drugs-in-tv-a ↩︎
  28. Martha Ryan and Neeraj Sood, State Drug Pricing Transparency Laws: Numerous Efforts, Most Fall Short, (USC Schaeffer Center for Health Policy & Economics, September 2019), https://healthpolicy.usc.edu/research/state-drug-pricing-transparency-laws-numerous-efforts-most-fall-short/. ↩︎
  29. Ge Bai, Mariana Socal, Michael Sharp, and Eric Pachman, “Medicaid Managed Care Programs’ Contracts For Generic Drugs Are Inefficient,” Health Affairs Blog, (May 2019), https://www.healthaffairs.org/do/10.1377/hblog20190426.775617/full/. ↩︎
  30. Government Accountability Office, 340B Drug Discount Program: Oversight of the Intersection with the Medicaid Drug Rebate Program Needs Improvement, (GAO, January 2020), https://www.gao.gov/assets/710/703966.pdf ↩︎
  31. Government Accountability Office, Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement (GAO, June 2018). https://www.gao.gov/products/gao-18-480 ↩︎
  32. Department of Health and Human Services, Advisory Opinion 20-06 On Contract Pharmacies Under The 340B Program, (HHS, December 2020), https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/340B-AO-FINAL-12-30-2020_0.pdf ↩︎
  33. Government Accountability Office, Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement (GAO, June 2018). https://www.gao.gov/products/gao-18-480 ↩︎
  34. CMS, Medicaid Covered Outpatient Prescription Drug Reimbursement Information by State, https://www.medicaid.gov/medicaid/prescription-drugs/downloads/medicaid-covered-outpatient-prescription-drug-reimbursement-information-state.pdf ↩︎
  35. MACPAC, The 340B Drug Pricing Program and Medicaid Drug Rebate Program: How They Interact, (MACPAC, May 2018), https://www.macpac.gov/wp-content/uploads/2018/05/340B-Drug-Pricing-Program-and-Medicaid-Drug-Rebate-Program-How-They-Interact.pdf. ↩︎
  36. HRSA, 340B Ceiling Price Calculation, https://www.hrsa.gov/opa/updates/2015/may.html ↩︎
  37. The federal government establishes maximum payment amounts for about 700 multiple-source drugs including both generics and originator brands for which generic versions are now available. The Affordable Care Act and subsequent rules set reimbursement at 175% of the weighted average of the most recently reported average manufacturer prices (AMP) for that drug. For more, see https://modern.kff.org/medicaid/issue-brief/pricing-and-payment-for-medicaid-prescription-drugs/ ↩︎
  38. After moving to average acquisition cost (AAC), most states increased dispensing fees while ingredient costs decreased. For more discussion, KFF, Pricing and Payment for Medicaid Prescription Drugs, (KFF 2020) https://modern.kff.org/report-section/pricing-and-payment-for-medicaid-prescription-drugs-issue-brief ↩︎
  39. Best price only applies to brand drugs, generic drug rebates are 13% of AMP ↩︎
  40. Medicaid statute defines Best Price as “the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or government entity within the United States.” There are many important exclusions, including the Department of Veterans Affairs, the 340B program, the Department of Defense, the Public Health Service, the Indian Health Service. The Best Price includes rebates in general, but not Medicaid supplemental rebates or rebates provided through the Medicaid Drug Rebate Program. 42 U.S.C. 1396r-8 (c)(1)(C). ↩︎
  41. Congressional Budget Office, A Comparison of Brand-Name Drug Prices Among Selected Federal Programs (CBO, February 2021), https://www.cbo.gov/system/files/2021-02/56978-Drug-Prices.pdf ↩︎
  42. Strengthening Medicaid and the Affordable Care Act, 86 Fed. Reg. 7793 (Feb. 2, 2020). https://www.federalregister.gov/documents/2021/02/02/2021-02252/strengthening-medicaid-and-the-affordable-care-act ↩︎
News Release

Analysis Suggests Health Insurers Remained Profitable Across Markets Amid Pandemic in 2020

Published: May 3, 2021

A new analysis of health insurers’ financial data suggests that they remained profitable across markets in 2020 due in part to an unprecedented decrease in health spending and utilization in the spring as the COVID-19 pandemic led to massive shutdowns.

The analysis examines insurers’ 2020 data for four distinct markets: Medicare Advantage, Medicaid managed care, individual (non-group), and fully insured group (employer). Across the four markets, insurers showed higher gross margins per enrollee per month in 2020 than the previous year, ranging from an average of $188 for Medicare Advantage plans to an average $71 for Medicaid managed care.

Similarly, insurers across the board reported paying out a smaller percentage of the premiums they collected as claims in 2020 than they did in 2019. Generally, lower medical loss ratios mean that insurers have more income remaining after paying medical costs to use for administrative costs or keep as profits.

The pandemic’s effect on health spending and insurer financial performance in 2021 remains uncertain. By the end of the 2020, health care utilization has largely returned to pre-pandemic levels, and there could be additional pent-up demand for care that had been missed or delayed last year.

News Release

What Could the U.S. Do to Help Improve Global COVID-19 Vaccine Equity?

Published: Apr 30, 2021

As India and other countries continue to grapple with major COVID-19 outbreaks even as cases decline in this country, there is increasing attention to the global role that could be played by the U.S. government.  This is particularly the case now that the U.S. will soon have enough COVID-19 vaccine doses to fully vaccinate everyone in the country, and has also purchased additional doses of vaccines not yet authorized in the U.S.  A new issue brief identifies the actions already taken by the U.S. government, reviews the main policy options on the table, and discusses key considerations in evaluating those options.

The main U.S. policy options for expanding global access that have been proposed fall into four general areas: Scaling up donations of surplus COVID-19 vaccines, providing additional funding for global vaccine efforts such as COVAX, helping to expand vaccine manufacturing, and relaxing or waiving intellectual property restrictions on COVID-19 vaccine technologies.

Some of the steps already taken by the U.S. include providing $4 billion in funding for COVAX, announcing plans to donate U.S. doses of the AstraZeneca vaccine to India, and announcing it would prioritize production and export of materials and supplies for vaccine manufacturing to India. The brief examines these and other proposed policy actions. With growing attention to global disparities in vaccine access, calls for U.S. action across these areas are likely to increase over time.

Global COVID-19 Vaccine Equity: U.S. Policy Options and Actions to Date

Published: Apr 30, 2021

The U.S. is expected to soon have enough COVID-19 vaccine doses on hand to fully vaccinate just about everyone in the country once, and, with additional doses already purchased, could likely vaccinate the population twice over. The same cannot be said for the majority of countries around the world, especially low- and middle-income countries (LMICs) where access has been limited and will remain so for some time. Furthermore, while manufacturers are scaling up vaccine production, total projected production in 2021 of 9.8 billion is still short of estimated need of up to 11.5 billion to vaccinate everyone globally. Recent actions restricting or pausing the use of the AstraZeneca and Johnson & Johnson vaccines in some countries due to extremely rare but serious side effects could reverberate globally, potentially prolonging the vaccine access gap given that these two vaccines have been positioned as key workhorses for ramping up vaccinations in LMICs in particular. Further, the expected need for booster doses and reformulated vaccines to address waning immunity and variants means global demand is likely to remain extremely high for the foreseeable future. Ultimately, ensuring widespread global access to COVID-19 vaccines, which is key to preventing cases and deaths and contributing to global population immunity, is a significant challenge and one that could threaten the ability to control the pandemic.

Federal officials, from Federal Reserve Chair Jerome Powell to Secretary of State Anthony Blinken, have argued that addressing global vaccine inequity is in the U.S. interest, and the Biden administration has already taken some steps to address the issue (see Table 1). But with global COVID-19 cases reaching their highest levels to date in recent weeks and many countries facing unprecedented waves of cases and deaths, there have been increasing calls for the U.S. to do more. This brief reviews the main policy options that have been proposed, and related questions, and identifies the actions taken by the administration thus far (see Table 1). These policy options fall into four main areas:

  • Scaling up in-kind donations of surplus COVID-19 vaccines
  • Providing additional funding for global vaccine efforts such as COVAX
  • Helping to expand vaccine manufacturing
  • Relaxing or waiving intellectual property (patent) restrictions on COVID-19 vaccine technologies
Table 1: Summary of Primary Policy Options for Expanding Global Access to COVID-19 Vaccines, and U.S. Actions Taken to Date*
Policy OptionU.S. Actions to DatePotential Additional Actions
In-kind donations of vaccine doses
  • Administration “loaned” up to 4 million U.S.-owned doses of AstraZeneca to Mexico and Canada
  • Administration announced 60 million AstraZeneca doses to be donated after FDA safety review
  • Administration announced an additional 20 million other U.S.-owned and authorized vaccines will be donated by the end of June
  • Provide further bilateral or regional donations of U.S. owned AstraZeneca and/or other vaccines
  • Provide multilateral donations of U.S. owned vaccines, through COVAX or other mechanism
Funding for global vaccine efforts
  • Congress appropriated $4 billion to Gavi for COVID-19 vaccine procurement and distribution via COVAX, with $2 billion provided initially and another $2 billion provided contingent upon other donor support for Gavi/COVAX. The U.S. has already provided $2.5 billion, and is the single largest donor to COVAX.
  • Appropriate additional funding for Gavi/COVAX
  • Provide funding for other global/regional vaccine procurement and distribution efforts such as via the World Bank, or the African Union.
Expanding manufacturing
  • Administration enacted Defense Production Act to prioritize COVID-19 vaccine materials/supplies
  • Prioritized production and export of materials and supplies vaccine manufacturing in India
  • Administration helped broker production partnerships and licensing agreements between companies to spur vaccine manufacturing, including financial incentives
  • Intervene more directly and more aggressively in support of additional partnerships
  • Provide incentives such as financing and/or advance purchase guarantees, or a “technology buyout”
  • Incentivize or require technology transfer between current manufacturers and those in other countries
  • Incentivize or require companies to participate in WHO’s mRNA vaccine technology transfer hub
  • Assist in bolstering regulatory and safety capacity for COVID-19 manufacturing in LMICs
Relaxing/Waiving Intellectual Property Protections
  • Lawmakers in the House and Senate have called for the US government to waive patents on COVID-19 vaccines
  • Administration announced its support for an intellectual property waiver for COVID-19 vaccines, to be negotiated at the World Trade Organization (WTO)
  • Impose federal waiver on intellectual property within federal jurisdiction related to COVID-19 vaccines
  • Support WHO-led COVID-19 Technology Access Pool (C-TAP); incentivize or require companies to participate
NOTES: *More details discussed below in each section, with sources linked.

Policy Options

In-Kind Vaccine Donations

The U.S. has already purchased enough of the three authorized vaccines to fully vaccinate its entire population. Counting the purchased doses from two other vaccines that are not yet authorized by the FDA but may be soon, AstraZeneca (already being used in more than 90 countries) and Novavax (yet to be authorized for use), the U.S. will own enough doses soon to vaccinate its population twice over (see Table 2). If current production and delivery goals are met, the number of U.S. doses in hand would be more than enough to vaccinate every U.S. adult by June this year, with additional projected deliveries beyond that enough to vaccine all children as well. This means the U.S. will soon have a significant number of “surplus” doses, at least enough to vaccinate an additional 150 million people and perhaps as many as 300 million beyond its own population. Even considering some doses may be held in reserve to address the problem of variants, it is clear many U.S.-owned doses are likely to go unused here.

Table 2: COVID-19 Vaccine Doses Owned by the U.S.
VaccineNumber of doses ownedNumber of people that could be vaccinated
Pfizer300 million150 million
Moderna300 million150 million
Johnson & Johnson200 million200 million
AstraZeneca*300 million150 million
Novavax*100 million50 million
Total1.2 billion700 million
U.S. Population331 million
Potential “Surplus”369 million
NOTES: * Not yet authorized by the FDA for use in the U.S.SOURCE: KFF analysis of Operation Warp Speed contracts and US government announcements.

In a National Security Memorandum released in the early days of the Biden administration, the President directed the Secretaries of State and Health and Human Services to develop a framework for donating surplus vaccines, once there is sufficient supply. The U.S. announced in March it would “loan” 4 million U.S.-owned doses of the AstraZeneca vaccine to Canada and Mexico. As COVID-19 cases and deaths began to surge in India and other countries in April, the administration announced it would donate up to 60 million AstraZeneca doses overseas, including to India, pending an FDA safety review. Further, in May the Administration announced it would be donating an additional 20 million doses of U.S.-owned and authorized vaccines (including doses of Pfizer, Moderna, and Johnson and Johnson), bringing the total number of pledged, in-kind donations to 80 million doses.

Going forward, there are some outstanding issues to be considered regarding vaccine donations, including the timing, volume, and specific mix of vaccines that could be donated, as well as legal issues. On timing, it could still be several months until the U.S. reaches the point when policymakers feel all who want a vaccine have received one, opening up the possibility for more donations beyond the 80 million already pledged. It is possible the U.S. may seek to hold a portion of its surplus doses in reserve in anticipation of the need for booster shots, and/or to expand vaccinations to more children. It is not yet clear if existing vaccine formulations and purchased vaccine doses would be sufficient to serve as booster shots, or if purchase of additional, modified vaccine formulations will be needed to vaccinate against variants. How our understanding of this scientific question evolves in the coming months and the timing will likely have implications for the availability of U.S. doses for donation. Regarding the mix of vaccines for donation, AstraZeneca is the first candidate of choice for in-kind donations, given that there is a growing stockpile of this vaccine unused in the U.S., it has not yet been authorized for use in the U.S., and Administration officials have said the U.S. may not need that vaccine for domestic purposes. However, any U.S. owned vaccines, including the three vaccines already authorized for use (Pfizer, Moderna, and Johnson and Johnson), as well as the Novavax vaccine, which has yet to be authorized by the FDA, could be candidates for further donations . Which vaccines are eligible to be donated may hinge on legal issues that arise around the contracts signed between the U.S. government and pharmaceutical companies supplying the vaccines. Concerns have been raised about the legality of donating U.S. purchased vaccines due to potential indemnification and liability issues for vaccine manufacturers. Beyond these issues, and, given the pressure to vaccinate Americans, the topic of U.S. donations is a politically sensitive one, where the administration will need to balance domestic need for vaccination with the reality that global coverage is critical to controlling the pandemic. This was reflected in President Biden’s recent remarks stating that he expects the U.S. to be the “arsenal of vaccination” for other countries, but only after “every American” has access to vaccines.

Funding for Global Vaccine Access

A number of international efforts to expand access to COVID-19 vaccines have already been launched. The most prominent of these is COVAX, an international partnership led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and the World Health Organization (WHO), which supports vaccine development, procurement, and distribution globally. COVAX has an initial goal of procuring and distributing enough doses to be able to vaccinate up to 20% of the populations in 92 low- and middle-income countries, and over 100 countries have already started to receive doses through COVAX with these deliveries set to expand further over the coming months. Despite the successes so far, COVAX faces a number of challenges to meeting its goal, including a significant funding gap. The initiative has received commitments of approximately $8.5 billion to date, but estimates it needs at least $11.5 billion through 2021 to achieve its goal. One recently published analysis [pre-print, not yet peer reviewed] estimates that $74 billion in funding will be required to support COVAX or other global vaccination efforts in order to reach 70% of the population vaccinated in low- and middle income countries.

The U.S. is already providing significant levels of funding for global vaccine distribution, with Congress appropriating $4 billion in emergency funding to Gavi in support of COVAX. The White House announced that it would provide an initial $2 billion contribution to Gavi for COVAX, and work to leverage further global contributions by releasing the remaining $2 billion through 2022, of which the first $500 million would be made available when existing donor pledges were fulfilled and initial doses delivered. To date, the U.S. has provided $2.5 billion, making the U.S. the largest single donor to COVAX. The U.S. also hosted the recent launch of a campaign to stimulate further donor investment in COVAX, with the goal of raising an additional $2 billion for the effort by June of this year. While some have called for the U.S. to provide more funding for COVID-19 vaccines, it is unclear whether there will be further appetite among U.S. policymakers to do more in this regard, though it is likely the administration will continue to play a leadership role in encouraging a more robust response by others.

Expansion of Manufacturing

While recognizing a significant financing gap exists, the most significant short-term constraint to scaling access remains the inadequate supply of vaccines globally. Additional donor financing would make a difference but alone cannot change the gap between supply and demand the world faces over the short term. As the WHO Director-General remarked recently: “more funding is needed, but that’s only part of the solution. Money doesn’t help if there are no vaccines to buy.” Currently much of the capacity to make COVID-19 vaccines, especially those employing newer technological approaches like mRNA, is concentrated in the hands of a few pharmaceutical companies primarily in high-income countries, and production occurs in only a small number of locations. Expanding this capacity is constrained by many factors, including: the challenging, complex process to make COVID-19 vaccines; limited quantities of necessary raw materials and supplies; a shortage of adequate manufacturing facilities and know-how; and weak governance and regulatory structures for vaccine production in many places. Key policy options, and actions to date, are as follows:

Bolstering production supply chains. Ensuring adequate raw materials and supplies is essential for scaling up vaccine production, but global COVID-19 vaccine supply chains are complex and fragile and have experienced shortages as production has scaled up. The U.S. has invoked the Defense Production Act over a dozen times in the last year in part to bolster access to raw materials and capacity for domestic manufacturing purposes, actions which helped spur U.S.-based vaccine production. It is possible that further action prioritizing vaccine manufacturing inputs broadly, where the federal government has jurisdiction to do so, could help address global supply limitations. In one recognition of how U.S. actions can affect the global supply of raw materials, the Biden Administration recently announced it was removing impediments to the export of vaccine raw materials to India as part of a set of actions meant to assist that country. Still, there is a potential for negative secondary effects when a government directs or exerts influence over supply chains. For example, supply disruption can ensue and some producers could have more difficulty accessing inputs if they are being channeled elsewhere. Exerting influence this way might disrupt or delay manufacturing of other types of products that use some of the same inputs.

Production partnerships, licensing agreements, and technology transfer. As of February 2021, at least 70 private production and licensing agreements have been announced publicly in support of COVID-19 vaccine manufacturing, including Pfizer and Novartis, AstraZeneca and Serum Institute of India, and Novavax and SK Bioscience. Many of these private sector deals have been undertaken by industry actors on an ad-hoc and voluntary basis, though at times governments have played an active role in forging them. For example, in March the Biden Administration announced it had helped broker a partnership between Johnson & Johnson and Merck, in which Merck agreed to convert some of its manufacturing capacity to producing the Johnson & Johnson COVID-19 vaccine. The deal was aided by the U.S. invoking the Defense Production Act and providing over $200 million in government financing to help Merck pay for upgrades to their manufacturing facilities.

Therefore, a potential avenue to expand manufacturing further is for the U.S. and others to intervene more directly and more aggressively in support of additional partnerships, which could include identifying and bringing together potential partners, actively brokering deals, and/or providing incentives such as financing and/or advance purchase guarantees, or even a “technology buyout” where the government pays a company a lump sum to make their specialized vaccine production knowledge and processes public. This set of approaches includes supporting “technology transfer” – sharing COVID-19 vaccine manufacturing know-how from companies already making the vaccine mostly in higher income countries to other companies primarily in lower-income countries. Additional potential manufacturing capacity does exist beyond the relatively small number of higher income countries currently producing vaccines but tapping into that capacity requires companies to share and instruct others on (often) proprietary techniques, components, and processes. WHO has recently launched a global mRNA vaccine technology transfer hub to assist in the transfer of vaccine know-how. Given the complexity of production chain for these vaccines and the multiple suppliers and steps involved, technology transfer agreements can cover manufacturing from any point from generating individual components of the vaccines, to producing the vaccines themselves, to the final “fill-finish” step of placing the product in vials.

For the most part, pharmaceutical companies have resisted most government intervention to accelerate technology transfer beyond industry-led voluntary licensing. A common argument against more forceful action on this front is that tapping into new and unproven manufacturing partners could jeopardize the quality and safety of COVID-19 vaccines, especially where there is inadequate regulatory systems and poor oversight to ensure quality of the product. In addition, there is a question about how much money and time it takes to successfully transfer technology for COVID-19 vaccine production; some have estimated it can take up to a year and cost up to $1 billion to see the process through and obtain regulatory approval for new facilities. However, one analysis of COVID-19 vaccine technology transfer and licensing deals to date estimates companies that had pre-existing drug/vaccine manufacturing capabilities started producing doses about 6 months on average after a deal was made.

Whether or not the U.S. will seek to further enhance manufacturing capacity, including technology transfer more broadly, is unknown. Key questions include whether the government will push for greater action in light of industry resistance, what kind of incentives and how much additional monetary support the U.S. might provide to help advance these kinds of deals, and whether the U.S. can and would engage to help overcome barriers around regulation, oversight and quality of production elsewhere.

Relaxing/Waiving Intellectual Property Protections

Companies with authorized COVID-19 vaccines often have intellectual property protection (i.e., patents) on key technologies or innovations related to their vaccines and/or manufacturing processes, most of which predated the pandemic. Such protections are designed to protect the patent holder from unfair competition and unlicensed copying of these innovations, and are often defended as being necessary to provide companies with the incentive to invest in research, development and innovation. Many advocates, governments, world leaders, and others have called for relaxing or waiving patent protections, either temporarily or permanently, for COVID-19 vaccines to allow other manufacturers access to these technologies without being concerned about violating intellectual property protections, which may incentivize increased global production.

Several proposals along these lines have been made. One calls for manufacturers to voluntary share intellectual property via a multilateral technology patent pool, such as the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). This mechanism, endorsed by over 40 countries, could allow generic or other manufacturers around the world to access the protected technologies and use them to start producing vaccines. Though this mechanism was formally proposed almost a year ago, no pharmaceutical company has voluntary shared its patents for COVID-19 vaccines through this mechanism, and in fact some have come out strongly against it, instead expressing preference for voluntary licensing deals (as discussed above). Another proposal, initiated in October 2020 by India and South Africa at the World Trade Organization (WTO), calls for patent protections on COVID-19 vaccines to be waived altogether for the duration of the pandemic. On May 5, the Biden Administration came out in favor of such a waiver, announcing that it will actively participate in WTO-based negotiations to make the waiver happen. While a majority of WTO member states support this idea, including now the United States, it has been met with opposition from a number of European countries with large pharmaceutical industries including the United Kingdom, Switzerland, and other members of the European Union. Negotiations on the waiver continue, and it is expected to be months before any decision could be reached.

Advocates for waiving intellectual property rights in this case point out that much of the innovation costs related to COVID -19 vaccines have been borne by governments and non-profit/philanthropic organizations, not the companies that now hold the patents. According to one recent estimate, public and non-profit funders have provided over $10 billion in funding to support vaccine research, development, and manufacturing globally. The U.S. government in particular has significant leverage over some COVID-19 vaccine intellectual property because of long-standing government investments in advancing this technology. In fact, as of March 30 of this year the government holds a patent to one of the key technologies used in vaccines from Moderna, Johnson & Johnson, Novavax, CureVac and Pfizer-BioNTech, and could potentially use this as leverage to sway these companies to share technology.  For these reasons some have argued the government could relax or waive patents via legal provisions such as “march-in” rights, potentially opening up production to generic competition. Many advocates, and over 30 members of Congress, have already called on the Biden administration to support an intellectual property waiver for COVID-19 vaccines along these lines. While the Biden administration is reported to be considering it and officials have met with pharmaceutical companies to discuss the issue, few details are available as to if and to what extent the government will move in this direction, and pharmaceutical companies so far have been publicly resistant to the idea of intellectual property waivers.

There are several arguments commonly raised against waiving intellectual property rights for global production of COVID -19 vaccines. For one, many pharmaceutical companies say it would undermine incentives for investment in research and development if patent protections are not provided for their innovations; a coalition of these companies recently re-stated this principle, saying that intellectual property protections are the “cornerstone” of a “dynamic and thriving” research ecosystem. In addition, some have argued that intellectual property rights are not even an important barrier to expanding access, and actions to relax or waive patents – on their own – would do little to incentivize greater investment and production in needed vaccines. For example, it has been Moderna’s policy since at least October 2020 that the company “will not enforce” its COVID-19 related patents for the duration of the pandemic, and the company is willing to “license its intellectual property for COVID-19 vaccines to others”, but so far no companies other than the ones Moderna itself has reached licensing deals with have pursued this. Finally, it has been argued that undermining patent rights might not even be legal under U.S. law.

Conclusion

As the U.S. and several other high-income countries continue to accelerate their own vaccine efforts, and have secured enough supply for their own populations at least once over, attention to global disparities in vaccine access is rising. The issue is all the more urgent as daily cases globally reach the highest reported numbers since the start of the pandemic, and deaths in many countries are at record highs with many countries lacking access to vaccines. Beyond the  inequities across countries, the lack of global access directly impact U.S. national interests and the U.S. economy, because limited vaccinations worldwide has the effect of extending the pandemic, raising risks for all countries, and causing social and economic disruptions. While there is a cost associated with increasing vaccine production and distribution, it is likely to be dwarfed by the cost of a longer, deadlier pandemic. For this reason many policy leaders and economists have argued that the U.S. economic recovery from the pandemic rests on the success of the global vaccination campaign. While recognizing the U.S. has already taken a number of steps to address the vaccine inequity crisis, we can expect that the pressure to do more will only increase over time.

COVID-19 Test Prices and Payment Policy

Authors: Nisha Kurani, Karen Pollitz, Dustin Cotlliar, Nicolas Shanosky, and Cynthia Cox
Published: Apr 29, 2021

Note: this analysis was updated on April 28, 2021.

This analysis examines what large hospitals nationwide charge for out-of-network COVID-19 tests. It finds a wide range of publicly posted prices; in many cases, the prices exceed what Medicare pays for COVID testing.

New federal guidance released in early 2021 under the Biden Administration clarified that insurers must cover testing without cost sharing for asymptomatic individuals and without requiring medical screenings. However, insurers are not required to cover COVID-19 testing without cost-sharing if it is conducted as part of employee return-to-work programs or public health surveillance purposes. Such limits to federal law coverage requirements mean some patients with health coverage may nonetheless receive bills for COVID-19 diagnostic testing and related services, and those bills often can be widely different from patient to patient.

The analysis examines publicly posted prices at the two largest hospitals in each state and the District of Columbia. Prices for COVID-19 diagnostic tests could be found on the websites of 93 of the 102 hospitals examined. The prices reflect what they would charge for out-of-network services. Data on the negotiated rates for in-network services is not available.

The analysis is part of the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.

How Corporate Executives View Rising Health Care Cost and the Role of Government

Authors: Gary Claxton, Larry Levitt, Shawn Gremminger, Bill Kramer, and Matthew Rae
Published: Apr 29, 2021

Introduction

With the events of past year, how we view health care in the United States is changing. The COVID pandemic has made even more clear the problems with our current system, including high costs, incomplete coverage, limited access to care, under-investment in public health, and serious racial and ethnic inequities. All of this, occurring against a backdrop of ever-rising health care costs, is causing many to re-think their priorities and positions on key health care policy issues.

In addition, the recent election has changed the political landscape and extended the range of policy options that likely will be discussed at the national level. During his campaign, President Biden proposed new coverage options that would broaden access to public coverage. One would create a Medicare-like public health coverage option that some people could elect in lieu of their current coverage. Another would lower the age of eligibility for Medicare to age 60. In addition, there appears to be bipartisan support for strengthening antitrust enforcement and limiting anti-competitive actions that are used by some health care entities to gain market power and increase prices, including proposals that would regulate or cap prices for high-cost drugs. Each of these proposals interject an expanded public role in providing coverage and restraining costs for populations that are largely now served by private health plans. Since these proposals are controversial and likely to face opposition from large parts of the health care industry, it is important to assess the level of support among key stakeholders.

Large employers are a primary source of private coverage, and thus are important stakeholders who will be influential in policy debates. Their views on health policy issues, however, are largely unknown. Many assume that business leaders tend to favor market solutions and oppose government involvement, but this is untested. Our objective was to find out what business leaders felt about health care issues – especially cost and coverage – and their opinions about potential government actions to address these problems.

To better understand how large employers may react to these and similar proposals, the Purchaser (formerly “Pacific”) Business Group on Health (PBGH) and the Kaiser Family Foundation (KFF) surveyed executive decision-makers at over 300 large private employers about how they view the costs of health care and health coverage and the potential advantages and disadvantages of increasing the government’s role in providing health coverage and reducing costs. The interviews were conducted in December 2020 and January 2021 by Beresford Research. The research project was supported by a grant from the Gary and Mary West Health Institute.

At a high level, we found significant concerns regarding health care costs. A significant majority of responding large employers “moderately” (49%), considerably (28%), or “strongly” (6%) agreed that the cost of health benefits is excessive. Employers did not blame any single cause for excessive costs, with large shares agreeing that the cost of prescription drugs, provider market consolidation and increased market power, volume-based payments, and unhealthy behaviors each are “moderate” or “considerable” or “very large” factors for high costs.

In addition, we found a significant amount of agreement with the need for greater government roles in providing coverage and addressing health care costs. A majority of responding large employers expressed some level of agreement with policy changes that would create a public option for employees and lower the Medicare eligibility age, both for their own employees and for the public more generally. Equally interesting, only small shares expressed disagreement with these ideas.

Majorities of responding large employers also expressed agreement with the need for more government involvement in containing health care costs. Interventions including capping hospital prices in non-competitive markets, limiting out-of-network charges, and negotiating or limiting drug prices in certain cases all had majority support. There was considerable support for pursuing policies that would increase transparency of prices and costs and that would increase antitrust enforcement or otherwise address non-competitive conduct. Overall, large shares of respondents agreed that a greater role for the government in providing coverage and containing health care costs would better for their business (83%) and better for their employees (86%).

Findings

APPROACH

PBGH and KFF worked with Beresford Research to survey key decision-makers at large U.S. employers that provide health benefits to their employees. Respondents were surveyed about their views around the cost of health benefits and potential expansion of government roles in providing benefit alternatives and in addressing health care costs. The survey was designed by researchers at KFF, PBGH, and Beresford Research. Telephone surveys were completed by Beresford Research with a convenience sample of representatives from 302 employers with at least 5,000 employees, widely distributed by region and industry. Respondents were chief executive officers, chief financial officers, chief operational officers, chief human resource officers, or people directly reporting to those positions. A detailed breakout of respondents is shown (see Toplines). Follow-up conversations were completed with 10 of the respondents to get additional information and perspective on their views. The telephone surveys were completed in December 2020 and January 2021. KFF and PBGH researchers analyzed the responses and prepared this report.

BACKGROUND

Health benefits make up a meaningful share of employee compensation, averaging 7.3 percent for private-sector employers. While annual growth in benefit costs has been modest in recent years (at least relative to prior decades), benefit costs are already high and they continue to increase faster than wages and prices in general. Employer health plans already pay much higher prices for health care goods and services than public coverage programs, and the gap is growing. Provider consolidation, particularly among hospitals, limits the potential for competitive strategies to reduce benefit costs. Pricing for new pharmaceutical products, where manufacturers have significant power to set prices, also fuels cost growth. Innovative approaches developed by employers and other payers to address costs (e.g., centers of excellence for back surgeries; expanding virtual care alternatives; value-based cost-sharing) may affect the rate of cost growth, but they have had little impact on reducing cost levels or reducing the gap with respect to public payment rates.

The recent election brought into office policymakers, including the new President, who support more expansive governmental roles in both coverage and cost containment. As a candidate, President Biden proposed providing people with the choice to enroll in a new public health insurance option, similar to Medicare, that would negotiate prices with health care providers. The option would be broadly available, including to employees and family members now covered through employer-based coverage. People offered employer-based plans generally are not eligible for this assistance now, though President Biden’s campaign plan would remove that restriction. Candidate Biden also proposed, as part of the Biden-Sanders Unity Task Force proposals, that people be given the option of enrolling in Medicare when they turned age 60.

In terms of health care costs, President Biden made several proposals to restrain prices and cost growth that could assist sponsors and enrollees in employer-based plans including government negotiating of drug prices, limiting price growth for new brand, biotech, and certain generic drugs, aggressively using anti-trust authority to address consolidation in health care markets, restricting surprise medical bills, and accelerating the development and use of generic drugs and biosimilars.

FINDINGS

The responding employers largely believe that the cost of health benefits is excessive. While in general respondents felt that employers individually or collectively can have an impact on health care costs, more than four in five believe that the cost of providing health benefits will become unsustainable at some point in the next five to ten years, and that there will need to be a greater role for government in providing coverage and controlling costs. Respondents generally expressed some agreement with a variety of policies that would expand the government’s role in health benefits, including limiting provider prices in non-competitive situations and expanding options for employees and others to enroll in public programs.

Cost of Health Benefits

Nearly all respondents agreed that health benefit costs are excessive. About half (49%) of respondents moderately agreed with the statement that employer costs for health benefits are excessive, with another 33% considerably or strongly agreeing. Only 4% of respondents disagreed with the statement.

Respondents did not single out any one factor as the primary reason for excessive costs. We asked respondents about the importance of four contributors to high health care costs: prescription drug prices; market consolidation among hospital and health care provider consolidation (with increased market power to raise prices); unhealthful behaviors among large segments of the population; and payments to hospitals and clinicians based on volume of services and not on patient outcomes. The pattern of responses was similar for each, with large shares of respondents saying that each was a “moderate” or “considerable” reason for high costs.

Although respondents largely agreed that the cost of health benefits is excessive, large shares believe that employers can change the cost of health care to some extent, both overall and for their own companies. Over half (56%) of respondents agreed that employers collectively can change health care costs to a moderate extent, with another 29% agreeing that employers can change costs to a considerable or large extent. For their own companies, 42% said that they could change health care costs to a moderate extent while 35% said that they could change costs to a considerable or large extent.

When asked why they believed that employers could influence costs, respondents mentioned things such as the ability to adjust employee costs (deductibles and worker contributions) or benefits as well as the potential of wellness programs to moderate costs. Others noted that many factors were outside of employer control. Large shares of respondents said that they were at least moderately likely to implement one or more cost-control practices, ranging from value-based benefit designs to higher deductibles.

Even while a majority of respondents felt that they could change the costs of health care, 87% of respondents believe that the cost of providing health benefits to employees will become unsustainable in the next 5 to 10 years, and 85% believe that there will need to be greater government roles in providing coverage and containing costs.

Greater Government Roles in Cost and Coverage

Respondents overwhelmingly believe that a greater government role in providing coverage and containing costs would be better for their business (83%) and better for their employees (86%). Respondents who said that a greater government role might be better for their business or their employees were asked why they thought so; among those who believed it would be better for their business, 43% said that it could reduce employee premium costs and 42% said that it could reduce costs for employers. Other potential benefits mentioned by these respondents included improving employee health and productivity and providing more benefit options for employees.

We asked respondents about their support for more specific government policies that would increase the government’s role in controlling health care costs, particularly in non-competitive market situations. Large shares of respondents agreed that policymakers should pursue policies that would strengthen anti-trust enforcement and prohibit anti-competitive conduct by providers, pharmaceutical manufacturers, and health plans (92%) or improve the transparency of prices and the total cost of care (90%). Although less well supported, 56% of respondents thought policymakers should pursue policies to reduce barriers to the development and use of generic drugs and biosimilar products.

Many respondents also expressed some support for more direct government intervention in health care pricing in certain circumstances. More than one-third of respondents “somewhat” or “strongly” agreed with government policies that would cap prices for hospitals in markets with limited or no competition; limit prices charged by out-of-network providers in surprise billing situations, and negotiate prices for high-cost sole-source drugs or setting limits on drug price increases. Fewer than 5% of respondents expressed any disagreement with any of these potential interventions.

In addition to policies to directly control health care prices and spending, we asked respondents about two proposals made by President Biden during his campaign that would extend public benefit coverage options to more people, including people with employment-based coverage. The first would create a public program option, similar to Medicare, broadly available to residents, and the second would provide people the option of enrolling in Medicare when they reach age 60.

These proposals could be of interest to employers because they are potential alternatives to the employment-based benefits that they offer, and which could be available to employees at the employee’s option. Depending on the financing, these options could reduce employer costs by reducing plan enrollment; this could be particularly significant in the case of lowering the Medicare eligibility age because older workers have some of the highest costs on average in employer plans. At the same time, providing options to employees could be disruptive to employer plans and upset planning, at least at the outset, and particularly if employees could move back and forth. Employers also may be concerned that they may be asked to participate in the financing of these options, which could offset any potential cost savings.

Respondents were asked about their level agreement with these two proposals, for either the general public or for their employees. Overall, large shares of responding employers expressed at least slight agreement with each proposal, both for the public in general and for their own employees. Perhaps surprising, few respondents expressed any level of disagreement with the options, with virtually no strong disagreement expressed by any respondent. This lack of disagreement may reflect the lack of detail about how these coverage options might operate or be financed, but it appears that employers may be open to this type of proposal and not opposed in general to extending public coverage options to more people, including their own employees.

More generally, we also asked respondents for their opinions about several potential advantages and disadvantages that could result from greater government roles in health care coverage and costs. As potential positives, about three in five respondents agreed that a greater government role might relieve employers of the responsibility and costs of managing health benefits, with a similar percentage agreeing that it may enable the government to hold down health care costs. Forty-seven percent of respondents said that a greater government role may enable increased consumer choices, while only 29% said that it could reduce administrative costs. As potential negatives, 43% said that the government does not have a great track record of managing big programs effectively, 41% said that the political influence of the health care industry would deter government actions to reduce costs, and 30% said that the government may not be able to design benefits to meet employee needs.

DISCUSSION

The business executives we surveyed showed perhaps a surprising degree of openness to proposals that would increase government roles in health care. Judging from some of the follow-up interviews, this openness appears to be less reflective of a belief that the government operates programs better or more effectively than the private sector, and more reflective of a long-standing frustration with the health care system and what are perceived to be constant and excessive increases in costs with little transparency into why they occur. More than four in five respondents agreed that the cost of providing health benefits would become unsustainable in the not too distant future and that this would necessitate a greater government role in providing coverage and restraining costs. As one respondent noted in a follow-up interview, “if it’s not the government stepping in, who would it be?”

While many respondents are confident that they can affect their own benefit costs at least to some degree, the primary levers they mentioned – increasing employee costs or reducing benefits – are not necessarily appealing or consistent with the goal of having an attractive benefit package for current and prospective employees. From this perspective, proposals to cap or limit prices in cases where markets are not working may be attractive to business executives because they offer employees some respite from high prices without reducing benefits or increasing enrollee costs. One respondent noted in the follow-up interviews about why he felt that government intervention was needed:

Over the long-term, yes. I think it will be business’ approach to continue to cut costs and cut benefits to control costs, simply because we don’t have the scale with which to really affect the change in the cost to us as well as we would want to. The end result is our employees get less benefits and use more of their take-home pay towards their share of their benefits to subsidize what the employer needs. I do think the model has to change because we’re going to be delivering less value to our employees unless the model does change and more pressure is put back in control of pricing to the providers and to the healthcare system generally.

The proposals to expand government programs also may be seen as an opportunity for employers to offload some of their costs, which may explain the clear openness to the ideas without any strong disagreement. In particular, providing people age 60 with the option to enroll in Medicare could help employers with some of their most costly enrollees. While the financing and benefit details associated with these proposals will be very important in how employers ultimately assess them, what seems clear from the responses is that respondents were more worried about the status quo than the prospect of a greater government role in providing health coverage alternatives for their workers.

The new political landscape may portend a new and more viable discussion of expanded roles for government in providing health coverage and restraining prices and costs. While this has long been controversial, the results of this study suggest that the employers are frustrated by the current health care system and their limited opportunities to address cost and that they may be open to options that involve a broader role for government.

This work was supported in part by the West Health Institute. We value our funders. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.

 

News Release

Vast Majority of Large Employers Surveyed Say Broader Government Role Will Be Necessary to Control Health Costs and Provide Coverage, Survey Finds

Most Business Leaders Favor Increased Anti-Trust Enforcement, Prohibitions on Anti-Competitive Practices, Capping Drug and Hospital Prices in Non-Competitive Markets; A Public Option and Lower Medicare Eligibility Age Seen as Viable Options

Published: Apr 29, 2021

Top executives at nearly 90% of large employers surveyed believe the cost of providing health benefits to employees will become unsustainable in the next five-to-10 years, and 85% expect the government will be required to intervene to provide coverage and contain costs, according to a new survey released today from Purchaser Business Group on Health (PBGH) and KFF (Kaiser Family Foundation), with support from the West Health Institute.

The research exposes large employers’ mounting concerns about the future of employer-sponsored coverage, with 87% of respondents saying they believe that the cost of providing health benefits to employees will become unsustainable in the next five to 10 years.

More than 300 executive decisionmakers at companies with over 5,000 employees responded to the survey in December 2020 and January 2021. The survey report was released today in advance of a web briefing jointly held by PBGH and KFF examining the views of business leaders on health policy.

“This survey highlights what we’ve understood for some time: The current health care system is on an unsustainable path,” said Elizabeth Mitchell, President and Chief Executive Officer of PBGH. “Our large employer members support competition and prefer market solutions. But they have reached their limit; they’re tired of pouring tons of money into a broken health care market that delivers uneven quality at bloated costs.”

Annual family premiums for employer-sponsored health insurance reached $21,342 in 2020, up 55% since 2010 and increased at a rate at least twice that of both wages (27%) and inflation (19%). During the same period, the average single employee deductible increased from $917 to $1,644 among workers with a deductible.

Employer health plans are already paying much higher prices for health care goods and services than public plans: Hospitals across the country charge employers and private insurance companies an average of 2.5 times what they get from Medicare for the same care, and three or more times Medicare prices in a half-dozen states.

“Any efforts to expand public coverage options or restrain prices will be met with strong opposition from the health care industry,” said Larry Levitt, Executive Vice President for Health Policy at KFF and an author of the report. “Employers, who foot much of the nation’s health care bill, could be a powerful counterweight.”

“Skyrocketing health care costs pose a significant threat to the prosperity of business and American workers. Every extra dollar spent on health care is one less dollar available for wages, investments and other essential business expenses,” said Shelley Lyford, President and Chief Executive Officer for West Health.

“Employers are getting a raw deal and they need to leverage their collective power in Washington to inspire action from lawmakers – particularly at a time when the economy is reeling from a pandemic.”

Among the central takeaways from the PBGH-KFF-West Health Survey:

Four-in-five respondents (87%) believe the cost of providing health benefits will become unsustainable in the next five to 10 years.

85% of respondents said the government will be required to play a greater role in providing health care coverage and containing costs in the next five-to-10 years; 83% said such actions would be better for their business and 86% said these actions would be better for their employees.

92% of respondents believe policymakers should pursue policies that would strengthen anti-trust enforcement and prohibit anti-competitive conduct by providers, pharmaceutical manufacturers and health plans; 90% would support actions that improved the transparency of prices and the total cost of care.

More than one-third of respondents somewhat or strongly agreed with government policies that would cap prices for hospitals in markets with limited or no competition; limit prices charged by out-of-network providers; and negotiate prices for high-cost, sole-source drugs or set limits on drug price increases.

Relatively few respondents generally disagreed with proposals that would lower the age of Medicare eligibility to age 60 or create a new public plan coverage option, either for their own employees or the general public. This lack of disagreement may reflect the absence of detail about how these options ultimately could play out, but employers nonetheless appear open to extending public coverage options to more individuals, including their own employees.

Mitchell of PBGH concluded: “Clearly, a consensus has emerged among those who foot the bills that the health care industry is not taking seriously enough the impact of rising costs that fail to correlate with higher quality health care.”

The KFF-PBGH survey was conducted between December 2020 and January 2021 by Beresford Research in partnership with the Gary and Mary West Health Institute (West Health). The telephone survey was designed by researchers at KFF, PBGH and Beresford Research, and relied on convenience sample of opinion from representatives of 302 employers with at least 5,000 employees. The responding organizations were widely distributed by region and industry. Individual respondents included chief executive officers, chief operational officers, chief human resource officers, or individuals directly reporting to these positions. Follow-up conversations were conducted with 10 of the respondents to gain additional information and insight.

About Purchaser Business Group on Health. PBGH is a nonprofit coalition representing nearly 40 private employers and public entities across the U.S. that collectively spend $100 billion annually purchasing health care services for more than 15 million Americans and their families. In partnership with large employers and other health care purchasers, PBGH initiatives are designed to test innovative operational programs and scale successful approaches that lower health care costs and increase quality across the U.S.

About KFF. Filling the need for trusted information on national health issues, KFF (Kaiser Family Foundation) is a nonprofit organization based in San Francisco, California.

About West Health. Solely funded by philanthropists Gary and Mary West, West Health is a family of nonprofit and nonpartisan organizations including the Gary and Mary West Foundation and Gary and Mary West Health Institute in San Diego, and the Gary and Mary West Health Policy Center in Washington, D.C. West Health is dedicated to lowering healthcare costs to enable seniors to successfully age in place with access to high-quality, affordable health and support services that preserve and protect their dignity, quality of life and independence. Learn more at westhealth.org and follow @westhealth.

 

Federal Medicaid Outlays During the COVID-19 Pandemic

Authors: Madeline Guth, Robin Rudowitz, and Rachel Garfield
Published: Apr 27, 2021

This data note analyzes federal Medicaid outlays before and during the COVID-19 pandemic. In the one year since the onset of the pandemic, federal Medicaid outlays totaled $500.8 billion and grew by 19.5%, compared to 6.3% growth in the one year before the pandemic. The first fiscal quarter of the pandemic (April to June 2020) saw particularly high outlays due to the beginning of enhanced federal Medicaid funds. Outlays remained high in the following three quarters (July 2020 through March 2021), reflecting this continued enhanced federal match as well as increased enrollment.

The outlay data analyzed in this data note comes from The Monthly Treasury Statement of Receipts and Outlays of the United States Government. The Bureau of the Fiscal Service (part of the U.S. Department of the Treasury) publishes these Monthly Treasury Statements, which summarize the financial activities of the U.S. federal government including receipts and outlays of funds. Specifically, this data note analyzes the Treasury data on outlays of the federal government classified as “grants to states for Medicaid.”1   This analysis examines quarterly and yearly outlays to understand the implications of the pandemic and the enhanced federal matching funds. Prior to the pandemic, states reported only incremental changes to Medicaid enrollment and spending, generally driven by rising prescription drug costs, incremental provider rate increases, and, in a small number of states, recent implementation of the Affordable Care Act (ACA) Medicaid expansion.2  Comparing quarterly outlays for the years before and during the pandemic allows for a comparison to what may be more typical quarterly variation.

As part of the federal response to the COVID-19 pandemic, states may access enhanced federal Medicaid funds. States and the federal government jointly finance Medicaid. The pandemic has generated both a public health crisis and an economic crisis, with major implications for Medicaid, a countercyclical program. During economic downturns, more people enroll in Medicaid as incomes fall, increasing program spending at the same time state tax revenues may be falling. To both support Medicaid and provide broad fiscal relief as state revenues declined precipitously, the Families First Coronavirus Response Act (FFCRA) authorized a 6.2 percentage point increase in the federal Medicaid match rate (“FMAP”) (retroactive to January 1, 2020) available if states meet certain “maintenance of eligibility” (MOE) requirements. This FMAP increase does not apply to the Affordable Care Act expansion group, for which the federal government already pays 90% of costs. States could draw down the increased federal matching funds beginning at the end of March for claims paid in the first quarter of 2020 and in early April for the second quarter of 2020.3  The FMAP increase will expire at the end of the quarter in which the public health emergency (PHE).

In the one year since the onset of the coronavirus pandemic, federal Medicaid outlays grew by 19.5%, compared to 6.3% growth in the one year before the pandemic (Figure 1). Total outlays in the four fiscal quarters since the pandemic (April 2020 through March 2021) were $500.8 billion, representing a 19.5% increase over the prior year’s outlays of $419.1 billion. After the onset of the COVID-10 pandemic and the passage of the FFCRA in March 2020, quarterly outlays in Quarter 3 of FFY 2020 (April through June 2020) were $127.4 billion, an increase of 22.5% over Quarter 3 outlays in the prior year. This initial increase likely reflects Medicaid claims retroactive to January that were made available at the end of March as well as enhanced matching funds for the second quarter. After this initial spike in outlays immediately following the FMAP increase, quarterly outlays have been somewhat lower but still significantly higher than the prior year. This trend reflects the continued enhanced federal match as well as increased enrollment due to requirements that states maintain continuous coverage for Medicaid enrollees to access the enhanced match and also to the economic downturn.

Figure 1: Federal Medicaid outlays have increased by 19.5% in the year since the onset of the coronavirus pandemic.

Continued growth in federal Medicaid outlays through March 2021 (the end of the second quarter of FFY 2021) likely reflects federal matching for increased state Medicaid spending during the pandemic. National data shows an increase in Medicaid enrollment of 10.8% from February to November 2020, a reversal of trends prior to the pandemic when enrollment was declining. While the enhanced FMAP shifts some state spending on this increased enrollment to the federal government, the sustained federal outlay growth in the quarters after the FMAP increase first took effect likely reflects overall Medicaid spending growth that is experienced at the state-level as well as the federal level. State spending growth during the pandemic likely varies across states based on economic conditions as well as the populations experiencing increased enrollment in each state (for example, increases in expansion enrollment would result in smaller increases in state spending due to the 90% federal match rate for this population).

The duration of federal fiscal relief to state Medicaid programs during the pandemic, which will affect both state and federal Medicaid spending in the future. The enhanced FMAP provides federal fiscal relief that helps replace state spending, so federal Medicaid spending growth may continue to outpace state spending growth while the enhanced FMAP is in place. When the fiscal relief expires, federal spending growth will fall and state spending growth will increase sharply. Although the current PHE declaration expires on July 20, 2021 (which means the enhanced FMAP is slated to expire at the end of September 2021), the Biden Administration has indicated that the PHE will likely remain in place throughout 2021 and that states will receive 60 days’ notice prior to its expiration or termination. This announcement means that the FMAP increase is likely to continue through at least the end of March 2022. The American Rescue Plan Act of 2021 expanded the FMAP to 100% for the administration of COVID-19 vaccines to Medicaid enrollees and also provided options for states to receive additional temporary FMAP increases, including for expanded home and community-based services and as an incentive for new adoption of the ACA Medicaid expansion. These increases will likely shift additional Medicaid spending from states to the federal government.

  1. The March 2021 Monthly Treasury Statement can be accessed at https://www.fiscal.treasury.gov/reports-statements/mts/current.html and all others included in this data note (April 2018 through February 2020) can be accessed at https://www.fiscal.treasury.gov/reports-statements/mts/previous.html. The data included in this date note is from the row titled “Grants to States for Medicaid” in Table 5 of these statements, titled “Outlays of the U.S. Government.” These grants to state Medicaid programs are included in the federal government’s total outlays to the Department of Health and Human Services. These grants do not include outlays to the Children’s Health Insurance Fund (CHIP). ↩︎
  2. Two states (Maine and Virginia) implemented Medicaid expansion under the ACA in January 2019 and two others states (Idaho and Utah) implemented the expansion in January 2020. These expansions may contribute to higher federal Medicaid outlays in the quarter that expansion was implemented. Similarly, Nebraska’s implementation of expansion in October 2020 may contribute to higher federal Medicaid outlays in the first quarter of FFY 2021. ↩︎
  3. CMS, COVID-19 FAQs for State Medicaid and CHIP Agencies, Section 5.F (updated as of 1/6/2021), https://www.medicaid.gov/state-resource-center/downloads/covid-19-faqs.pdf. ↩︎