The No Surprises Act: A Conservative Band-Aid to Protect Business as Usual.

Hailed as a major reform, the No Surprises Act (NSA) is a profoundly conservative law that aims neither to reform design of insurance, to regulate fees, nor to limit health care spending. The NSA mitigates a perverse but narrow problem: unpredictable and uncontrollable high out-of-pocket bills for individuals who are unable to receive care within their insurance network. However, the NSA neglects to address the broader high medical costs, limited choice of caregivers, and the resulting insecurity and unfairness that characterize American health care. It allows caregivers to extract high payments and insurers to restrict choice of caregivers. Insurers can continue to employ ineffective cost controls that generate unpredictable high out-of-pocket costs for patients-and high levels of denial of payments to doctors and hospitals. The law amputated the most politically and visibly gangrenous consequences of unregulated private insurance in the United States in ways that enable business as usual in private health insurance to persist, subject to unnecessarily complex arbitration rules that magnify administrative waste.

Assessing US Pharmaceutical Policy and Pricing Reform Legislation in Light of European Price and Cost Control Strategies.

This article compares the pharmaceutical pricing policies employed by public and private insurers in the United States with seven price and spending control strategies employed in the United Kingdom, France, and Germany. Differences between American and European policies explain why American pharmaceutical prices and per capita spending are higher than in European nations. The article then analyzes two recent bills as examples of significant American reform ideas-H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (introduced in 2019) and the Build Back Better Act (BBBA, introduced in 2021)-and compares them with European cost control strategies. Key drug price provisions of the BBBA were incorporated into the recently enacted Inflation Reduction Act (IRA). H.R. 3 would have used an international (mostly European) price index to cap U.S. prices; the BBBA would cap Medicare prices at a discount from average U.S. market prices. Neither bill would employ the key cost control strategies that European nations do. Both bills would have significantly less impact on prices than legislation that employs European-style cost controls. This article proposes steps that Congress could take in line with European strategies to lower purchase prices and costs for patients. These measures would have to overcome political obstacles that currently stymie reform.

WHO's Attempt to Navigate Commercial Influence and Conflicts of Interest in Nutrition Programs While Engaging With Non-State Actors: Reflections on WHO Guidance for Nation States Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool".

This commentary situates the comments submitted in response to the World Health Organization (WHO) draft guidance on conflicts of interest in national nutrition programs in light of: (1) WHO policies to protect WHO integrity; (2) the Framework of Engagement with Non-State Actors (FENSA); (3) WHO's attempt to seek funds due to cuts in member contributions; and (4) attempts-often by corporate entities-to redefine conflicts of interest to avoid oversight of conflicts of interest and increase corporate influence. The WHO guidance defines conflicts of interest in ways that deviate from standard legal usage which confuses its analysis and facilitates the creation of conflicted public-private partnerships. The guidance suggests that nations can allow engagement with non-state actors when the benefits are greater than risks without separate check due to conflicts of interest. Instead, the WHO should have recommended that nations seek alternative ways to achieve their goals when non-state actors have significant institutional conflicts of interest.

German Pharmaceutical Pricing: Lessons for the United States.

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell new drugs immediately upon receiving marketing approval. During the first year, the German Federal Joint Committee assesses new drugs to determine their added medical benefit. It assigns them a score indicating their added benefit. New drugs comparable to drugs in a reference price group are assigned to that group and receive the same reimbursement, unless they are therapeutically superior. The National Association of Statutory Health Insurance Funds then negotiates with manufacturers the maximum reimbursement starting the 13th month, consistent with the drug's added benefit assessment and price caps in other European countries. In the absence of agreement, an arbitration board sets the price. Manufacturers accept the price resolution or exit the market. Thereafter, prices generally are not increased, even for inflation. US public and private insurers control prices in diverse ways, but typically obtain discounts by designating certain drugs as preferred and by restricting patient access or charging high copayment for nonpreferred drugs. This article draws 10 lessons for drug pricing reform in US federal programs and private insurance.

How the United Kingdom Controls Pharmaceutical Prices and Spending: Learning From Its Experience.

To control costs and improve access, nations can adopt strategies employed in the United Kingdom to control pharmaceutical prices and spending. Current policy evolved from a system created in 1957 that allowed manufacturers to set launch prices, capped manufacturers' rates of return, and later cut list prices. These policies did not effectively control spending and had limited effects on purchase prices. The United Kingdom currently controls pharmaceutical spending in 4 ways. (a) Since 1999, it has typically paid no more than is cost-effective. (b) Since 2017, for medicines that will have a significant budget impact, National Health Service England seeks discounts from cost-effective prices or seeks to limit access for 2 years to patients with the greatest need. (c) Since 2014, statutes and a voluntary scheme have required branded manufacturers to pay the government rebates to recoup the difference between the global pharmaceutical budget and actual spending. (d) For hospitals, generics and some patented drugs are procured through competitive bidding; community pharmacies are reimbursed through a system that provides an incentive to beat average generic market prices. These policies controlled the growth of spending, with the largest effects following budget controls in 2014. Changes since 2008 have reduced savings, first by paying more than is cost-effective for cancer drugs and then by applying higher cost-effectiveness thresholds for some drugs used to treat cancer and certain other drugs.

Common Pharmaceutical Price and Cost Controls in the United Kingdom, France, and Germany: Lessons for the United States.

To identify pharmaceutical spending-control options for the United States, we analyzed the policies of the United Kingdom, France, and Germany, which encourage drugmakers to undertake innovations that improve health while controlling spending. Their main strategies today include: using legislation to set default rules that increase the insurer's bargaining position, employing health technology assessment that measures cost-effectiveness or comparative effectiveness and caps the purchase or reimbursement price, setting a single maximum price for similar drugs (reference group pricing), capping prices near prices in other European countries (external reference pricing), prohibiting price increases, contracting to obtain discounts as sales volume rises, procuring drugs through competitive bids, and requiring manufacturers to pay rebates when spending exceeds a global budget. Each strategy addresses a distinct cause of high spending and supports overall goals. Most recent US reform proposals recommend incremental changes that would not address the major sources of high and increasing pharmaceutical prices. However, some US reform proposals resemble certain European strategies and could bring more significant change. US policymakers should consider adopting each of the strategies employed in these countries.

The use of 'added benefit' to determine the price of new anti-cancer drugs in France, 2004-2017.

BACKGROUND: Increasing drug prices strains budgets. Assessing the relation between added benefit and prices can help clinical decision-making and resource allocation. METHODS: We assessed, over a period of 13 years, the relation between added therapeutic benefit and prices for drugs to treat solid tumours in France using the French High Authority of Health Scale (ASMR) and the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (MCBS). RESULTS: In total, 36 medications were approved for 68 indications. There was a weak correlation between ASMR and MCBS scales (Spearman's |ρ| = 0.28). Drugs had low added benefit on both ASMR (71%) and MCBS (49%). Mean monthly price for new drugs was €4616 (S.D., €3096), ranging from €1795 to €19,675 and increased by 47% comparing 2004-2012 with 2013-2017. The mean monthly price difference of new drugs over their comparator was €3700 (S.D., €3934) ranging between a €13,853 decrease and a €19,675 increase. There was a weak but statistically significant correlation between ASMR and price (|ρ| = 0.35, p = 0.004) and between MCBS and price (|ρ| = 0.33, p = 0.005). Correlations between added benefit and prices were similar or higher for first indications (ASMR, |ρ| = 0.37, p = 0.030; MCBS, |ρ| = 0.48, p = 0.004). In first indications, mean monthly prices increased €3954 for drugs without ASMR added benefit. The mean annual price and price increase for first indications offering no ASMR benefit was €57,312 and €47,448, respectively. CONCLUSION: Prices and benefit are weakly correlated. However, prices increased substantially even for drugs with no added benefit.

Conflicts of Interest in Human Subject Research: The Insufficiency of U.S. and International Standards.

Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It finds current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

Attempts to redefine conflicts of interest.

The traditional legal concept of conflict of interest is a practical tool to regulate conduct. In recent years several medical authors have defined conflicts of interest in ways that stray from its original legal meaning. The new definitions cause conceptual confusion and will result in policies that cannot be implemented effectively. We should not follow recent attempts to redefine conflicts of interest because doing so deviates from the legal concept and will lead to deregulation of financial conflicts and overregulation of so-called intellectual conflicts.

Do We Need Stronger Sanctions to Ensure Legal Compliance By Pharmaceutical Firms?

The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that misconduct is widespread and even risks slipping into the banalities of ordinary business practices. It also raises questions as to whether current sanctions are an effective means to ensure compliance. This article explores the causes of the frequent illegal conduct, why prosecutors rarely use the strongest sanctions in their arsenal--criminal penalties and debarment from participation in public programs--and asks whether the use of the strongest sanctions would be desirable. Prosecutors might not use the strongest penalties available because of divided enforcement authority or because they prefer to seek monetary penalties to support their budgets. Moreover, strong sanctions might be perceived as imposing steep collateral damages on the-general public and being politically costly. If prosecutors are reluctant to impose the strongest possible sanctions, then policymakers need to develop alternative responses. One option is to create stronger economic penalties than the ones that currently exist. Corporations and their managers have incentives to increase their income, and their pursuit of profit sometimes leads these managers to violate the law. To deter illegal conduct, legislation typically allows courts to impose penalties--including fines and incarceration--on convicted individuals and firms. The increasing wide-scale illegal conduct by pharmaceutical firms and their employees over the last two decades prompts three questions. Are current sanctions sufficient? Are stronger sanctions and enforcement policy possible? If so, would they effectively deter harmful illegal conduct?

Introduction: Institutional corruption and the pharmaceutical policy.

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations.

Five un-easy pieces of pharmaceutical policy reform.

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies.

Rooting out institutional corruption to manage inappropriate off-label drug use.

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use.

Conflicts of interest, institutional corruption, and pharma: an agenda for reform.

When physicians' conflicts of interest arise from ties with drug firms, we should shift our focus to the pharmaceutical industry and improper dependencies that cause institutional corruption. This article analyzes eight forms of improper dependencies on pharma and proposes reforms.