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Context: Dramatic increases in pharmaceutical merger and acquisition (M&A) activity since 2010 suggest we are in the midst of a third wave of industry consolidation. Methods: The authors reviewed 168 economic, legal, medical, industry, and government sources to examine the effects of consolidation on competition and innovation and to explore how industry attributes complicate M&A regulation in a pharmaceutical context. Findings: The authors find that, in spite of certain metrics that might argue otherwise, consolidation consistently reduces innovation and harms the public good. They also find that several factors within the pharmaceutical industry impede proper evaluation of proposed mergers. Because consumer choice across substitutes is limited, pharmaceutical markets frustrate conventional methods of defining markets. Volume bargaining in the pharmaceutical supply chain and asset managers’ common ownership of pharmaceutical firms further complicate the definitional process. Hence, the Herfindahl-Hirschman Index (HHI), one measure used by the Federal Trade Commission and the Department of Justice to screen for concerning M&A activity, sometimes depends on faulty market definitions and fails to capture the implications of consolidation for future market share. Conclusions: The authors describe ways to improve how pharmaceutical markets are defined, highlight quantitative alterations to HHI to account for common ownership, and propose areas requiring further research.

International reference prices (IRP), also called external reference prices, are widely used across developed nations. IRP uses the prices paid in other countries to either inform negotiations with the pharmaceutical industry or as a cap on market prices. The authors review the application of IRP to cap the prices of negotiated outcomes in the context of US proposals for changing the way prescription drug prices are established for the Medicare program. They examine the economic, political, and administrative issues associated with the use of IRP, and they summarize the evidence on the impacts of IRP.

POLICY POINTS: Looking for a way to curtail market power abuses in health care and rein in prices, 20 states have restricted most‐favored‐nation (MFN) clauses in some health care contracts. Little is known as to whether restrictions on MFN clauses slow health care price growth. Banning MFN clauses between insurers and hospitals in highly concentrated insurer markets seems to improve competition and lead to lower hospital prices. CONTEXT: Most‐favored‐nation (MFN) contract clauses have recently garnered attention from both Congress and state legislatures looking for ways to curtail market power abuses in health care and rein in prices. In health care, a typical MFN contract clause is stipulated by the insurer and requires a health care provider to grant the insurer the lowest (i.e., the most‐favored) price among the insurers it contracts with. As of August 2020, 20 states restrict the use of MFN clauses in health care contracts (19 states ban their use in at least some health care contracts), with 8 states prohibiting their use between 2010 and 2016. METHODS: Using event study and difference‐in‐differences research designs, we compared prices for a standardized hospital admission in states that banned MFN clauses between 2010 and 2016 with standardized hospital admission prices in states without MFN bans. FINDINGS: Our results show that bans on MFN clauses reduced hospital price growth in metropolitan statistical areas (MSAs) with highly concentrated insurer markets. Specifically, we found that mean hospital prices in MSAs with highly concentrated insurer markets would have been $472 (2.8%) lower in 2016 had the MSAs been in states that banned MFN clauses in 2010. In 2016, the population in our sample that resided in MSAs with highly concentrated insurer markets was just under 75 million (23% of the US population). Hence, banning MFN clauses in all MSAs in our sample with highly concentrated insurer markets in 2010 would have generated savings on hospital expenditures in the range of $2.4 billion per year. CONCLUSIONS: Our empirical findings suggest banning MFN clauses between insurers and providers in highly concentrated insurer markets would improve competition and lead to lower prices and expenditures.

Promoting substitution of lower priced generics for brand drugs once the market exclusivity period for the latter expires is a key component of the US strategy for achieving value in prescription drugs.This study examines the effect of generic competition on drug prices by estimating the effect of entry of generic drugs, following a brand's loss-of-exclusivity (LOE), on the average price of competing drugs.Using the Medicare Part D drug event (PDE) data from 2007 to 2018, we utilize both fixed effects and random effects at the drug level to estimate the relationship of competitors and prices within each drug while controlling for factors across drugs. We follow a drug 24 months and 36 months after first generic entry to examine whether the relationship between number of suppliers and price would change over time. We also test the hypothesis that drugs with more recent LOE might face less competition than those with earlier LOE.We find that drug prices fall with increasing number of competitors. Prices decline by 20% in markets with about three competitors (the expected price ratio of current generic to pre-generic entry brand average prices is 80%). Prices continue to decline by 80% relative to the pre-generic entry price in markets of ten or more competitors (the expected price ratio is about 30% following 2 years after entry, dropping to 20% following 3 years after entry). We also find that the impact of competition on relative prices is similar for generic drugs first entering the market in either 2007-11 or 2012-15.Promoting generic entry and maintaining effective provider competition are effective methods for containing drug prices.

Although hospital consolidation within markets has been well documented, consolidation across markets has not, even though economic theory predicts-and evidence is emerging-that cross-market hospital systems raise prices by exerting market power across markets when negotiating with common customers (primarily insurers). This study analyzes hospital systems using the American Hospital Association Annual Survey Database and defines hospital geographic markets as commuting zones that link workers to places of employment. The share of community hospitals in the US that were part of hospital systems increased from 10 percent in 1970 to 67 percent in 2019, resulting in 3,436 hospitals within 368 systems in 2019. Of these systems, 216 (59 percent) owned hospitals in multiple commuting zones, in part because 55 percent of the 1,500 hospitals targeted for a merger or acquisition between 2010 and 2019 were located in a different commuting zone than the acquirer. Based on market-power differences among hospitals in systems, the number of systems in urban commuting zones that could potentially exert enhanced cross-market power increased from thirty-seven systems in 2009 to fifty-seven systems in 2019, an increase of 54 percent. The increase in cross-market hospital systems warrants concern and scrutiny because of the potential anticompetitive impact of hospital systems exerting market power across markets in negotiations with common customers.

The purpose of this article is to summarize and critique from a public health perspective the recent report from the U.S. Department of the Treasury (DOT) regarding competition in the beer, wine, and spirits markets in the United States.A critical review of the recent DOT report was conducted.The report is remarkable primarily for its ability to spend 64 pages on alcohol regulation and reference none of the public health literature either on the health, social, and economic burden of alcohol use or on the importance and effectiveness of regulatory policies to reduce that burden.The report is clear evidence that structural public health input into DOT deliberations about policy is missing. The department should create something parallel to its Office of Industry and State Outreach to ensure that future assessments of alcohol markets balance economic insights with public health data and evidence.

In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower-cost generics become available. Delayed generic drug uptake may increase spending and worsen medication adherence and patient outcomes. We assessed recent trends and factors associated with generic uptake.Among 227 drugs facing new generic competition from 2012 to 2017, we used a national claims database to measure generic uptake in the first and second year after generic entry, defined as the proportion of claims for a generic version of the drug. Using linear regression, we evaluated associations between generic uptake and key drug characteristics.Mean generic uptake was 66.1% (standard deviation 22.1%) in the first year and 82.7% (standard deviation 21.6%) in the second year after generic entry. From 2012 to 2017 generic uptake decreased 4.3% per year in the first year (95% confidence interval, 2.8%-5.8%, P.001) and 3.2%/year in the second year (95% confidence interval, 1.2%-5.1%). Generic uptake was lower for injected than oral drugs in the first year (38.5% vs 70.0%, P.001) and second year (50.3% vs 86.9%, P.001). In the second year, generic uptake was higher among drugs with an authorized generic (86.1 vs 80.1%, P = .045) and those with ≥3 generic competitors (87.7% vs 78.6%, P = .055).Early generic uptake decreased over the past several years. This trend may adversely affect patients and increase prescription drug spending. Policies are needed to encourage generic competition, particularly among injected drugs administered in a hospital or clinic setting.

Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets. Effective price competition remains the rule in generic markets for large-selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. Context The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price spikes, sustained high price-cost margins, and market disruptions. The mismatch between the canonical economic model of generic drug markets and reality motivated our empirical project. Methods To explore recent changes in those factors impacting the supply and demand for generic drugs, we studied, from a variety of sources, the data on price, competition, supply disruptions and recalls, changes to the supply chain, and buy-side concentration. We examined quarterly data through 2018 for a cohort of 77 molecules that lost patent protection during the so-called patent cliff between 2010 and 2013. Findings On the supply side, we found that for large-market oral solids, generic entry and price declines were consistent with past studies showing a significant number of market entrants and substantial reductions in the average price of a molecule. In smaller markets for oral solids and injectable products, we observed fewer entrants, higher rates of exit, smaller price reductions, and, in some cases, considerable price instability. The number of reported shortages increased across all generic market types over time, with the rate of shortage increases especially pronounced in markets for injectable products. The number of product recalls also rose over our study period. Although we did not estimate causal effects, we did find several changes in the market environment for generic drugs that may contribute to these phenomena. The demand side for generics has become more concentrated. Supply chains rely more on producers outside the United States (particularly from China and India). Contracting practices have undergone changes that may inhibit competition in product supply. FDA regulatory scruitiny has increased. Conclusions Competition in generic drug markets varies widely by market size and product form. Recent changes in demand-side market structure imply more downward pressure on prices stemming from buy-side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply-side changes point to further market instabilities across all generic markets due to producers' changing economic position.

Growth in pharmaceutical prices is a major policy issue in the United States. Competition is encouraged to counteract such growth, yet less is known about the effect of brand competition on prices. We discover a unique feature of this market by studying the pricing strategies of incumbent drug manufacturers under tiered-insurance anticipating branded competition. Using the insulin market as a natural experiment, we exploit exogenous variation in several potential entrants' completion of clinical trials to identify the effect of drug pipeline pressure on the prices of incumbent drugs. We find that pipeline pressure exerts cumulative and significant upward pressure on prices of incumbent drugs. In the insulin market such pressure explained 10.5% of the growth of prices. We were able to replicate these findings among incumbents with other emerging biosimilars. Insurance designs that fail to promote price competition through negotiations and value-based principles may contribute to such price increases.

Background Through participation in payment reforms such as bundled payment and accountable care organizations (ACOs), hospitals are increasingly financially responsible for health care use and adverse health events occurring after hospital discharge. To improve management and coordination of postdischarge care, ACO hospitals are establishing a closer relationship with skilled nursing facilities (SNFs) through the formation of preferred SNF networks. Research design We evaluated the effects of preferred SNF network formation on care patterns and outcomes. We included 10 ACOs that established preferred SNF networks between 2014 and 2015 in the sample. We first investigated whether hospitals "steer" patients to preferred SNFs by examining the percentage of patients sent to preferred SNFs within each hospital before and after network formation. We then used a difference-in-difference model with SNF fixed effects to evaluate the changes in patient composition and outcomes of preferred SNF patients from ACO hospitals after network formation relative to patients from other hospitals. Results We found that preferred network formation was not associated with higher market share or better outcomes for preferred SNF patients from ACO hospitals. However, we found a small increase in the average number of Elixhauser comorbidities for patients from ACO hospitals after network formation, relative to patients from non-ACO hospitals. Conclusions After preferred SNF network formation, there is some evidence that ACO hospitals sent more complex patients to preferred SNFs, but there was no change in the volume of patients received by these SNFs. Furthermore, preferred network formation was not associated with improvement in patient outcomes.

BACKGROUND: Local market competition has been previously associated with more aggressive surgical decision-making. For example, more local competition for organs is associated with acceptance of lower quality kidney offers in transplant surgery. We hypothesized that market competition would be associated with the size of an abdominal aortic aneurysm (AAA) at the time of elective endovascular aneurysm repair (EVAR). METHODS: We included all elective EVARs reported in the Vascular Quality Initiative database (2012–2018). Small AAAs were defined as a maximum diameter

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

Objective We explore if there are ways to characterize health systems-not already revealed by secondary data-that could provide new insights into differences in health system performance. We sought to collect rich qualitative data to reveal whether and to what extent health systems vary in important ways across dimensions of structural, functional, and clinical integration. Data sources Interviews with 162 c-suite executives of 24 health systems in four states conducted through "virtual" site visits between 2017 and 2019. Study design Exploratory study using thematic comparative analysis to describe factors that may lead to high performance. Data collection We used maximum variation sampling to achieve diversity in size and performance. We conducted, transcribed, coded, and analyzed in-depth, semi-structured interviews with system executives, covering such topics as market context, health system origin, organizational structure, governance features, and relationship of health system to affiliated hospitals and POs. Principal findings Health systems vary widely in size and ownership type, complexity of organization and governance arrangements, and ability to take on risk. Structural, functional, and clinical integration vary across systems, with considerable activity around centralizing business functions, aligning financial incentives with physicians, establishing enterprise-wide EHR, and moving toward single signatory contracting. Executives describe clinical integration as more difficult to achieve, but essential. Studies that treat "health system" as a binary variable may be inappropriately aggregating for analysis health systems of very different types, at different degrees of maturity, and at different stages of structural, functional, and clinical integration. As a result, a "signal" indicating performance may be distorted by the "noise." Conclusions Developing ways to account for the complex structures of today's health systems can enhance future efforts to study systems as complex organizations, to assess their performance, and to better understand the effects of payment innovation, care redesign, and other reforms.

Objective To examine system integration with physician specialties across markets and the association between local system characteristics and their patterns of physician integration. Data sources Data come from the AHRQ Compendium of US Health Systems and IQVIA OneKey database. Study design We examined the change from 2016 to 2018 in the percentage of physicians in systems, focusing on primary care and the 10 most numerous nonhospital-based specialties across the 382 metropolitan statistical areas (MSAs) in the US. We also categorized systems by ownership, mission, and payment program participation and examined how those characteristics were related to their patterns of physician integration in 2018. Data collection/extraction methods We examined local healthcare markets (MSAs) and the hospitals and physicians that are part of integrated systems that operate in these markets. We characterized markets by hospital and insurer concentration and systems by type of ownership and by whether they have an academic medical center (AMC), a 340B hospital, or accountable care organization. Principal findings Between 2016 and 2018, system participation increased for primary care and the 10 other physician specialties we examined. In 2018, physicians in specialties associated with lucrative hospital services were the most commonly integrated with systems including hematology-oncology (57%), cardiology (55%), and general surgery (44%); however, rates varied substantially across markets. For most specialties, high market concentration by insurers and hospital-systems was associated with lower rates of physician integration. In addition, systems with AMCs and publicly owned systems more commonly affiliated with specialties unrelated to the physicians' potential contribution to hospital revenue, and investor-owned systems demonstrated more limited physician integration. Conclusions Variation in physician integration across markets and system characteristics reflects physician and systems' motivations. These integration strategies are associated with the financial interests of systems and other strategic goals (eg, medical education, and serving low-income populations).

The Role of Market Forces in U.S. Health Care The weaknesses associated with market-based health care systems are severe, but that does not mean the market should be abandoned. Relatively increment...

Given the potential benefits of Group Purchasing Organizations in cost-containment efforts for hospitals on supplies and purchased services, an important question that remains unanswered is what conditions support or hinder the utilization of GPOs by hospitals. Therefore, this study explores the relationship between GPO use by hospitals and their market and organizational characteristics. Data on hospital GPO utilization and other organizational characteristics were combined with secondary hospital market characteristics. Panel logistic regression with random effects and state and year fixed effects analysis was used to examine the relationship between hospitals' utilization of GPO services and hospitals' organizational and market characteristics. Overall, the majority of hospitals utilized the services of GPOs. Specifically, the number of hospitals utilizing the services of GPOs increased slightly from 3290 (72.2%) in 2004 to 3337 (74.4%) in 2013. In regression analyses, hospitals utilizing the services of GPOs operated in an external environment with mixed levels of munificence, more dynamism, and less competition. Specifically, hospitals operating in a less munificent environment are more likely to utilize the services of GPOs. The study findings provide organizational decision-makers and policymakers' insights into how certain market and organizational factors influence hospital strategy choice, in this case, the use of GPOs.

We used 2010-16 Medicare Cost Reports for 10,737 freestanding home health agencies (HHAs) to examine the impact of home health (HH) and nursing home (NH) certificate-of-need (CON) laws on HHA caseload, total and per-patient variable costs. After adjusting for other HHA characteristics, total costs were higher in states with only HH CON laws ($2,975,698), only NH CON laws ($1,768,097), and both types of laws ($3,511,277), compared with no CON laws ($1,538,536). Higher costs were driven by caseloads, as CON reduced per-patient costs. Additional research is needed to distinguish whether this is due to skimping on quality vs. economies of scale.

Background There is a concern that the Oncology Care Model (OCM), a voluntary bundled payment program, may incentivize mergers and acquisitions among physician practices leading to reduced competition and price increases. These concerns are heightened if OCM is preferentially adopted in competitive health care markets because it could result in reduced competition, but little is known about the characteristics of markets where OCM is adopted. Objective To measure the association between regional market competition among medical oncologists with the initial adoption of OCM. Research design The Herfindahl-Hirschman Index (HHI), a measure of competition, was calculated for hospital referral regions (HRRs) using secondary data from the Centers for Medicare and Medicaid Services. The relationship between HHI and OCM adoption was assessed using a 2-part regression model adjusting for the market-level number of practices, physician density, average practice size, sociodemographic characteristics, and medical resources. A count model on all HRRs was also estimated to assess an overall effect. Subjects A total of 10,788 physicians in 3,537 practices who billed Medicare for oncology services in 2015. Results OCM was adopted in 114 (37%) of the 306 HRRs. We found that practices in competitive health care markets were more likely to adopt OCM than in noncompetitive markets. Two-part regression analysis indicated a nonlinear relationship between HHI and OCM adoption. Average practice size, number of practices in an HRR, and the hospital bed rate were positively associated with adoption, whereas the rate of full-time equivalent hospital employees to 1000 residents was negatively associated with adoption. Conclusions OCM adoption was higher in HRRs with greater competition. Careful monitoring of market-level changes among OCM adopters should be undertaken to ensure that the benefits of the OCM outweigh the negative consequences of possible changes in competition.

States can challenge proposed hospital mergers by using antitrust laws to prevent anticompetitive harms. This observational study examined additional state laws-principally charitable trust, nonprofit corporation, health and safety, and certificate-of-need laws-that can serve as complements and substitutes for antitrust laws by empowering states to be notified of, review, and challenge proposed hospital mergers through administrative processes. During the period 2010-19, 862 hospital mergers were proposed, but only forty-two (4.9 percent) were challenged by states, including thirty-five by states without federal involvement, of which twenty-five (71.4 percent) originated in the eight states with the most robust merger review authority. The twenty-five challenges resulted in two mergers being blocked; three being abandoned; and twenty being approved with conditions, including seven with competitive-impact conditions. Hospital market concentration and prices increased at similar rates in these eight states versus other states, potentially because most challenges allowed mergers to proceed with conditions that did not adequately address competitive concerns. Although these findings do not reveal an optimal state framework, elements of advanced state merger review authority may have the potential to improve poorly functioning hospital markets.

Importance Price decreases of biologic and biosimilar products in Medicare Part B have been minimal, even with biosimilar competition. Medicare reimburses clinicians for biologics and biosimilars differently than for brand-name and generic drugs, which has generated greater price reductions. Objective To characterize the nature of price competition among brand-name and generic drugs under Medicare Part B and to estimate the cost savings to the program of subjecting biologic and biosimilar therapies to a similar price competition. Design, Setting, and Participants This cohort study analyzed all brand-name drugs and their approved generic versions as well as biologics and biosimilars that were reimbursed under Medicare Part B from quarter 1 of 2005 to quarter 2 of 2021. Two separate data sets were created: brand-name and generic drugs as well as biologics and biosimilars data sets. Brand-name products with generic versions that were introduced before 2005 were excluded, and so were vaccines. Exposures Number of generic and biosimilar competitors over time. Main Outcomes and Measures Price change as a percentage of the brand-name drug or biologic price in the quarter before generic or biosimilar competition. Price change was modeled using a linear, fixed-effects time series regression, with the number of generic or biosimilar competitors as the main covariate. Time was expressed as the number of quarters since the first generic or biosimilar competitor entered the market. Savings were estimated by projecting the regression model of brand-name and generic drug competition to observed biologic and biosimilar competition and by applying the estimated price reduction to actual Medicare spending for those products from 2015 to 2019. Results Of the 988 Healthcare Common Procedure Coding System codes identified, 50 (5.0%) met the inclusion criteria for the brand-name and generic drug data set and 28 (2.8%) met the criteria for the biologic and biosimilar data set. The first generic competitor was associated with reduced drug prices by 17.0%, the second competitor with a 39.5% decrease, the third competitor with a 52.5% decrease, and the fourth and more competitors with a 70.2% decrease (price decline was measured from brand-name drug price before the first generic competitor rather than from price established with fewer competitors). If biologics and biosimilars were subject to the same Medicare reimbursement framework as brand-name and generic drugs, Medicare spending on these products was estimated to have been 26.6% lower ($1.6 billion) from 2015 to 2019. Conclusions and Relevance This study found minimal uptake of biosimilars and limited price reductions for biologics and biosimilars under the current Medicare Part B reimbursement policy. Adopting the bundled biosimilar reimbursement structure for biologic and biosimilar therapies may be associated with substantial savings and encourage greater biosimilar market entry.

Private Equity and Physician Medical Practices In recent years, private-equity firms have emerged as influential players in the health care market, offering a lifeline to smaller groups needing a c...