Segment 5 – Why Is U.S. Healthcare So Expensive?

Segment 5 – Why Is U.S. Healthcare So Expensive?

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This segment reviews the “Perfect Storm” of reasons for unrestrained increase of healthcare spending in the U.S.

In Episode 4, we zeroed in on what I call the Real Problem with healthcare — relentlessly rising costs.

In this Episode, we will look at why the US spends so much on healthcare. As you can imagine, there are many reasons, not just one. In fact, it’s a perfect storm of bad reasons. We will also look whether we are getting our money’s worth.

Here’s the list. Part 1 & Part 2.

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We will go through each one.

Natural Spending Drivers

Let’s start with some natural drivers of health spending, which are understandable and expected. First, as the population grows, so will health spending. Likewise, as the proportion of older people increases, so will spending. We also expect health spending to increase slowly with inflation. New technologies and medicines increase cost, but we hope will give dramatic benefits. For example, during my 40-year practice lifetime I have seen the introduction of new drugs for diabetes, blood pressure, and virus infections including HIV and flu. I have seen new ultrasound, CT and MRI diagnostics. I have seen cardiac caths, by-passes and joint replacements. These new things are expensive but well worth the cost.

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But health spending grows from 1-1/2 to 4 times the rate of inflation, much more than would be explained by natural drivers, as we saw previously.

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Fee for Service Payments

So, let’s look at the other reasons. First and foremost, to my way of thinking, is fee-for-service. Doctors in the US – unlike other countries where they are salaried – get paid for piecework. If a surgeon doesn’t operate, he doesn’t get paid. If a specialist doesn’t have a patient scheduled, HE doesn’t get paid. Money is a powerful incentive. So we should not be surprised if doctors increase their own volume of services, many times unconsciously.

Health Insurance Hides Cost

The next big reason is our health insurance. Until recently premiums were paid by the employer and out-of-pocket copays were minimal. Healthcare felt free to most of us. Most of us had no idea what our care was costing the system, and cared little. Talk about a perfect storm!

Imperfect Market 

Why didn’t market forces keep down costs and spending. Many politicians and reformers think competition as the simple solution to the healthcare cost problem. But economists will tell you that healthcare is not a pure market;  they refer to it as “imperfect.” The reasons are first that no one knows the true price of anything. Have you ever tried to sort out a hospital bill? Ridiculous!

Second, markets rely on buyer and seller having equal footing to negotiate, but most patients dare not quibble with their doctor. Doctors get their feathers ruffled when patients challenge their advice. Third, to make matters worse, patients are a “captive market” – they are often suffering, frightened for their life, and desperate for immediate relief, not exactly a strong bargaining position. Fourth, doctors can control demand. There’s an old joke about the level of eyesight loss that needs a cataract operation – if there’s one doctor in town it’s 20/100, if two doctors it’s 20/80 and if three doctors in town it’s only 20/60.

Administrative Costs

Next is administrative costs. Some economists estimate that up to ¼ of all health spending is for administration, not actual care. This is not surprising knowing how complicated we make our delivery system and financing system. Other countries have one delivery system and one payment system. US has 600,000 separate doctors, 5,500 separate hospitals, and 35 different insurance companies, not counting Medicare and Medicaid. Doctors used to drown in papers; now we spend up to 2 hours doing computer work for every hour of patient care. Don’t you love it?

For comparison, Medicare reports only 2% administrative costs (but some other costs are hidden elsewhere in government).

Inefficiency & Waste

Some other spending drivers include inefficiency. I include in this category unnecessary tests and treatments, as well as wasted effort due to incompatible computerized record systems – there are 632 separate electronics vendors in the US. If airports ran this way, each airline at each airport would have its own unique air traffic control computer that did not connect with each other. All in the name of free market.

Regards unnecessary treatments and procedures, a doctor at Dartmouth named John Wennberg pioneered using Big Data in the 1980s to look at numbers of prostate operations in each individual ZIP code, and found that surgeons in some regions were operating 13 times for often in highest areas than the lowest. Since prostate disease is relatively constant everywhere, this can only mean that doctors practice varies widely – the highest utilizers are doing too many operations.

Monopolies

Next is monopolies. Many small- and medium-sized towns and rural areas can only support one hospital. This creates monopolies with no market forces whatsoever to hold down charges.

Cost Shifting

Cost-shifting means that uninsured patients come to the ER for care. Since the ER doesn’t get paid, the ER shifts the Uninsured cost into the bill for INSURED and Medicare patients. The cost-shifting itself doesn’t increase the costs, but getting care in an ER instead of doctor’s office is the most expensive possible place for care.

New-Technology Policy

The FDA new-technology policy means that FDA rules say that it will approve any new drug or treatment if it shows even the slightest statistical benefit, no matter how small. Some cancer drugs are approved that extend life by only a few weeks. Some medicines are approved, even if the number needed to treat is 100. For example, for some new cholesterol medications, 100 patients need to be treated for 5 years before we see even 1 heart attack prevented. That’s a lot of patients, and a lot of doses, and a lot of dollars. By comparison, since half of appendicitis patients die without treatment, and almost all with appendectomy surgery survive and live happily ever after, the calculated number-needed-to-treat is only 2. So appendectomies are a good valued, but cholesterol medication (for otherwise healthy people) is questionable value.

Non-Costworthy Marginal Benefit

Here is another way of looking at value. As we go from left to right in this graph, we are spending more and more on health care. The more we spend, the higher the cumulative health benefit, at least to start. The first section (Roman number I) are very high value interventions like public health, sanitation, immunizations. The next section (Roman number II) are good value routine health treatments, including kidney dialysis and first-line chemotherapy for treatable cancers. But when we reach the third section (Roman number III), the benefits level off. Bypass surgery is less effective for older patients (and more risky); dying patients don’t survive in intensive care units and are miserable with tubes and futile breathing machines. If we spend even more we reach section Roman numeral IV in which no additional benefit is gained, just a lot of extra testing, treatments or drugs – these are wasted dollars. And if we keep spending more yet, we actually do more harm than good, and can even have deaths on the operating table or reactions to too many drugs. The US is well into section IV and in some cases section V. A lot of other richer countries think that they have already reached the point where spending more will give no benefit or possibly do more harm than good, even though they spend less than the US.

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In the next episode we will look at the ramifications of so much health spending on the US economy, politics and society. We will look at some potential threats if we do not start to control costs better.

I’ll see your then.

 

Health Systems Need to Completely Reassess How They Manage Costs

https://hbr.org/2018/11/health-systems-need-to-completely-reassess-how-they-manage-costs

A recent Navigant survey found that U.S. hospitals and health systems experienced an average 39% reduction in their operating margins from 2015 to 2017. This was because their expenses grew faster than their revenues, despite cost-cutting initiatives. As I speak with industry executives, a common refrain is “I’ve done all the easy stuff.” Clearly, more is needed. Cost reduction requires an honest and thorough reassessment of everything the health system does and ultimately, a change in the organization’s operating culture.

When people talk about having done “the easy stuff,” they mean they haven’t filled vacant positions and have eliminated some corporate staff, frozen or cut travel and board education, frozen capital spending and consulting, postponed upgrades of their IT infrastructure, and, in some cases, launched buyouts for the older members of their workforces, hoping to reduce their benefits costs.

These actions certainly save money, but typically less than 5% of their total expense base. They also do not represent sustainable, long-term change. Here are some examples of what will be required to change the operating culture:

Contract rationalization. Contracted services account for significant fractions of all hospitals’ operating expenses. The sheer sprawl of these outsourced services is bewildering, even at medium-size organizations: housekeeping, food services, materials management, IT, and clinical staffing, including temporary nursing and also physician coverage for the ER, ICU and hospitalists. More recently, it has come in the form of the swarms of “apps” sold to individual departments to solve scheduling and care-coordination problems and to “bond” with “consumers.” There is great dispersion of responsibility for signing and supervising these contracts, and there is often an unmanaged gap between promise and performance.

An investor-owned hospital executive whose company had acquired major nonprofit health care enterprises compared the proliferation of contracts to the growth of barnacles on the bottom of a freighter. One of his company’s first transition actions after the closure of an acquisition is to put its new entity in “drydock” and scrape them off (i.e., cancel or rebid them). Contractors offer millions in concessions to keep the contracts, he said. Barnacle removal is a key element of serious cost control. For the contracts that remain, and also consulting contracts that are typically of shorter duration, there should be an explicit target return on investment, and the contractor should bear some financial risk for achieving that return. The clinical-services contracts for coverage of hospital units such as the ER and ICU are a special problem, which I’ll discuss below.

Eliminating layers of management. One thing that distinguishes the typical nonprofit from a comparably-sized investor-owned hospital is the number of layers of management. Investor-owned hospitals rarely have more than three or four layers of supervision between the nurse that touches patients and the CEO. In some larger nonprofit hospitals, there may be six. The middle layers spend their entire days in meetings or on conference calls, traveling to meetings outside the hospital, or negotiating contracts with vendors.

In large nonprofit multi-hospital systems, there is an additional problem: Which decisions should be made at the hospital, multi-facility regional, and corporate levels are poorly defined, and as a consequence, there is costly functional overlap. This results in “title bloat” (e.g., “CFOs” that don’t manage investments and negotiate payer or supply contracts but merely supervise revenue cycle activities, do budgeting, etc.). One large nonprofit system that has been struggling with its costs had a “president of strategy,” prima facie evidence of a serious culture problem!

Since direct caregivers are often alienated from corporate bureaucracy, reducing the number of layers that separate clinicians from leadership — reducing the ratio of meeting goers to caregivers — is not only a promising source of operating savings but also a way of letting some sunshine and senior-management attention reach the factory floor.

However, doing this with blanket eliminations of layers carries a risk: inadvertently pruning away the next generation of leadership talent. To avoid this danger requires a discerning talent-management capacity in the human resources department.

Pruning the portfolio of facilities and services. Many current health enterprises are combinations of individual facilities that, over time, found it convenient or essential to their survival to combine into multi-hospital systems. Roughly two-thirds of all hospitals are part of these systems. Yet whether economies of scale truly exist in hospital operations remains questionable. Modest reductions in the cost of borrowing and in supply costs achieved in mergers are often washed out by higher executive compensation, more layers of management, and information technology outlays, leading to higher, rather than lower, operating expenses.

A key question that must be addressed by a larger system is how many facilities that could not have survived on their own can it manage without damaging its financial position?  As the U.S. savings and loan industry crisis in the 1980s and 1990s showed us, enough marginal franchises added to a healthy portfolio can swamp the enterprise. In my view, this factor — a larger-than-sustainable number of marginal hospital franchises — may have contributed to the disproportionate negative operating performance of many multi-regional Catholic health systems from 2015 to 2017.

In addition to this problem, many regional systems comprised of multiple hospitals that serve overlapping geographies continue to support multiple, competing, and underutilized clinical programs (e.g., obstetrics, orthopedics, cardiac care) that could benefit from consolidation. In larger facilities, there is often an astonishing proliferation of special care units, ICUs, and quasi-ICUs that are expensive to staff and have high fixed cost profiles.

Rationalizing clinical service lines, reducing duplication, and consolidating special care units is another major cost-reduction opportunity, which, in turn, makes possible reductions in clinical and support personnel. The political costs and disruption involved in getting clinicians to collaborate successfully across facilities sometimes causes leaders to postpone addressing the duplication and results in sub-optimal performance.

Clinical staffing and variation. It is essential to address how the health system manages its clinicians, particularly physicians. This has been an area of explosive cost growth in the past 15 years as the number of physicians employed by hospitals has nearly doubled. In addition to paying physicians the salaries stipulated in their contracts, hospitals have been augmenting their compensation (e.g., by paying them extra for part-time administrative work and being on call after hours and by giving them dividends from joint ventures in areas such as imaging and outpatient surgery where the hospital bears most of the risk).

The growth of these costs rivals those of specialty pharmaceuticals and the maintenance and updating of electronic health record systems. Fixing this problem is politically challenging because it involves reducing physician numbers, physician incomes, or both. As physician employment contracts come up for renewal, health systems will have to ask the “why are we in this business” and “what can we legitimately afford to pay” questions about each one of them. Sustaining losses based on hazy visions of “integration” or unproven theories about employment leading to clinical discipline can no longer be justified.

But this is not the deepest layer of avoidable physician-related cost. As I discussed in this HBR article, hospitals’ losses from treating Medicare patients are soaring because the cost of treating Medicare patient admission is effectively uncontrolled while the Medicare DRG payment is fixed and not growing at the rate of inflation. The result: hospitals lost $49 billion in 2016 treating Medicare patients, a number that’s surely higher now.

The root cause of these losses is a failure to “blueprint,” or create protocols for, routine patient care decisions, resulting in absurd variations in the consumption of resources (operating room time; length of stay, particularly in the ICU; lab and imaging exams per admissions, etc.).

The fact that hospitals have outsourced the staffing of the crucial resource-consuming units such as the ICU and ER makes this task more difficult. Patients need to flow through them efficiently or the hospital loses money, often in large amounts. How many of those contracts obligate the contractual caregivers to take responsibility for managing down the delivered cost of the DRG and reward them for doing so? Is compensation in these contracts contingent on the profit (or loss avoidance) impact of their clinical supervision?

These are all difficult issues, but until they are addressed, many health systems will continue to have suboptimal operating results. While I am not arguing that health systems abandon efforts to grow, unless those efforts are executed with strategic and operational discipline, financial performance will continue to suffer.  A colleague once said to me that when he hears about someone having picked all the low-hanging fruit, it is really a comment on his or her height. Given the escalating operating challenges many health systems face, it may be past time for senior management to find a ladder.

 

 

Do Most Hospitals Benefit from Directly Employing Physicians?

https://hbr.org/2018/05/do-most-hospitals-benefit-from-directly-employing-physicians

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How can hospitals and health systems generate a return on their investment in their physician enterprises? According to the most recent figures, from the American Medical Association, over 25% of U.S. physicians practiced in groups wholly or partly owned by hospitals in 2016 and another 7% were direct hospital employees. Yet, according to the Medical Group Management Association, hospitals’ multi-specialty physician groups lost almost $196,000 per employed physician.

As a result, some larger health systems’ physician operations are generating nine-figure operating losses, which are major contributors to the deterioration in hospital earnings.  It is time for hospitals or health systems to rethink their strategy for their physician enterprises.

Let’s first revisit why independent physicians were receptive to becoming employees and why hospitals and health systems felt the need to hire them.

The surge in hospital employment of physicians predated Obamacare by at least six years, and had two key drivers. The first was independent baby-boomer physicians — particularly those in primary care — found themselves unable to recruit new partners. Newer physicians, heavily burdened by student debt, were not inclined either to take on entrepreneurial risk or the 60-hour work weeks independent practice entailed.

The second was cuts in Medicare payments for office-based imaging. Thanks to the Deficit Reduction Act of 2005, specialties such as cardiology, orthopedics, and medical oncology that relied on the revenue that imaging generated were hit hard. As a result, many found it advantageous to be employed by hospitals. Under Medicare rules, in addition to professional fees, hospitals can charge a Part B technical fee for their services and therefore can pay practitioners more than they could earn in private practice.

Then, beginning in 2009, the Obama administration’s policies increased the exodus of physicians from private practices to health systems. The “meaningful use” provisions of the HITECH Act of 2009 provided both incentives and penalties for physicians to adopt electronic records, but hospitals and very corporate enterprises had more resources to comply with meaningful-use requirements.

The value-based-payment schemes created by the Affordable Care Act also markedly increased documentation requirements and, as a result, the overhead of practices, driving more physicians into hospital employment models.

There have been a number of reasons hospitals have been hiring physicians. Some, particularly those in rural areas, had no choice but to turn physicians into employees. Retiring independent physicians were leaving large gaps in care in their economically challenged communities. Consequently, hospitals that did not step in to fill the gaps were in danger of closing.

Separately, some hospitals or systems sought to grab business from their competitors by acquiring physicians who hospitalized their patients at competing facilities. These physicians’ inpatient and, particularly, outpatient imaging and laboratory volume generated additional revenues for the acquiring hospital or system.

A third apparent motivation was to corner the local physician market in order to obtain more favorable rates from health insurers. This seemed to have been a major rationale for St. Luke’s Health Systems acquisition of Seltzer Medical Group, Idaho’s largest independent, multi-specialty physician practice group, which led to an anti-trust action.

Yet another reason for making physicians employees was to position the organization for capitated, or value-based, payment. Hospitals believed that “salarying” physicians would help control clinical volumes and thus make it easier to perform in capitated contracts.

Finally, some hospital and system CEOs were tired of negotiating with local independent physician groups or national physician-staffing firms like MedNax and TeamHealth over incomes and coverage of the hospitals’ 24/7 services such as the emergency department, the intensive care unit (ICU), and diagnostic services like radiology and pathology. Building an in-house staff of physicians seemed like an attractive alternative.

Many health systems have gotten into trouble because their strategic rationale for hiring physicians became a moving target.  A hospital system we followed morphed from a ““grab market share” strategy to a “respond to competitive acquisitions” strategy to a “bailout” strategy for loyal independent physicians to a “increase bargaining power with payers” strategy to a “position for value-based care” strategy over a period of eight years. By the time it was done, it was the proud owner of a 700-plus physician group and losses of more than $100 million per year.

Hospitals lose money on their employed physicians because physicians’ compensation plus practice expenses and corporate overhead significantly exceed the collections of practices. These direct losses are, to a degree, an artifact of accounting, because hospitals frequently do not attribute any bonus for meeting “value-based’ contract targets, or incremental hospital surgical, imaging, and lab revenues to physician practice income.

However, even factoring in the accounting issues, much of the losses are attributable to “hosting,” rather than managing, practices effectively.  Many systems employing physicians have done so without developing a cohesive physician organization and lack standardized staffing and operational support functions, such as effective purchasing and supply chain operations, effective scheduling systems, and centralized office locations.

Managing up the return, rather than managing down the loss, is the key to a successful physician strategy. Here’s how to do that.

Establish a clear strategic goal and a target return on investment. Physicians reside at the core of any successful health system. Yet as the Cheshire Cat said in Alice in Wonderland, “If you don’t care where you are going, then it doesn’t matter which way you go!” If you establish strategic goals for the physician enterprise, then the physician organization can be sized and located appropriately. As a result, the physician group may end up either a lot smaller or with a more defensible specialty and/or geographic distribution. Management should then quantify and budget the expected return on the practice’s operational loss.

Strengthen operations. Effective management of the physician group then becomes the essential challenge. For example, revenue-cycle issues such as inconsistent coding or missing data often damage the profitability of the medical group. Are systems in place to assure that medical bills are defensible and correct, and that patients understand what they owe and agree to pay? Seeing that encounters are adequately documented and translated into a fair and timely bill that patients are willing to pay is not rocket science. The return on investment for getting the revenue cycle right is often 3X to 5X.

Revamp compensation and incentives. Medicare’s policy for paying employed physicians will likely come under fresh scrutiny during the Trump administration. It is possible that Medicare’s relatively favorable payment for hospital-employed physicians will be reined in. If that happens, it might require a painful revisiting of employment contracts when they come up for renewal.

Performance incentives in those contracts should also match the strategic goals established above. For example, compensating physicians through a production-based model that encourages them to increase visits, procedures, or hospital admissions, while value-based insurance contracts (like those for accountable care organizations) demand reducing them could damage the overall performance of the health system.

Pursue reality-based contracts with insurers. The Affordable Care Act ushered in a profusion of narrow network, performance-based contracts with private insurers, with significant front-end rate concessions by hospitals. These discounts often far exceeded the potential rewards from the “value based” incentives in the contracts! Larger health systems also rushed to assemble “clinically integrated networks” (CINs), comprising their employed and contracted physicians as well as private practitioners in their markets, to participate in these new contracts. Treating physician group losses and CIN expenses as loss leaders for value-based contracts and then losing yet more money on those contracts, as is happening in many places, doesn’t make sense.

Both enrollment and financial performance under these contracts have been disappointing in most markets. Reviewing and pruning back these contracts, or renegotiating them to provide more adequate rates or to compensate hospitals for patient non-payment is an essential element of an effective physician-enterprise strategy. Hospitals and health systems also should ask: “Is the CIN functioning as intended? Is it adding value that patients notice or is it just an additional layer of administrative expense without compensating benefits for clinicians or patients?

Motivate employed and independent physicians. Finally, hospitals and systems must understand the value they are creating not only for their employed clinical workforce but also for the two-thirds of their physicians who are not full-time employees — those who are contracted, independent participants in CIN’s or in part-time administrative roles. What would motivate all these physicians to want to work with the organization over the long term?

Hospital and systems need a unified physician strategy and operating model that encompasses all these diverse arrangements. Beyond that, they must  engage their physicians in planning and organizing care. Physician are complex, highly trained professionals. They cannot be mere employees; they must be owners of the organization’s goals and strategies.

 

 

 

Despite shift to value-based care, hospitals still paying doctors with fee-for-service expectations, AMA says

http://www.healthcarefinancenews.com/news/despite-shift-value-based-care-hospitals-still-paying-doctors-fee-service-expectations-ama-says?mkt_tok=eyJpIjoiTXpGak1qTmhNbVUxWVRsaSIsInQiOiJwQlwvU1ZxcTU2bExreng4NXpEZ0Q2WkRYeldUbzlNM3kwWlJFeER5WlwvS3NqQ0lvMFwveHVNRExjdmVkdkRNMTBOb3FlZlwvOUJIMTYzR0tVWlNlcDJWMlRkMVM4TzZCK1I3XC9NSkFkc1U5QjhYaTZXKzhaUnY0M2RKNGNubTR5dk84In0%3D

 

A quick breakdown of the different approaches hospitals are taking to compensate physicians amid the massive shift from volume to value.

The shift from fee-for-service payment models to those based in value has been occurring steadily over the past few years. Increasingly, providers are determining physician pay through a number of different means. But what does that mean for the ways hospital pay doctors? And what approach are your competitors taking?

The options include straight salary, compensation based on personal productivity (as has been the case in a fee-for-service world), bonus structures and tieing pay to an organization’s overall financial performance.

Salary is the most common model at 52.5 percent, while productivity still accounted for 31.8 percent. Only 9 percent was based on the practice’s financial performance, meanwhile, and bonuses comprised 4.1 percent, according to an American Medical Association analysis.

Here’s where the plot thickens a bit. “Over half of physicians (54.4 percent) indicated that their compensation was based on more than one method, greater than what was observed in 2014 and 2012,” AMA said.

Productivity was a greater chunk of compensation for private practice owners, at 44.7 percent; that number dipped to 22.3 percent for employed physicians.

Partly that’s because employed physicians were more likely to have a salary, decreasing the need for productivity to factor into their overall compensation equation, the AMA said. The group said some physicians are likely feeling pressure to increase their productivity by doing things like increasing their patient volume, or hiring outside help to perform more menial tasks.

It’s worth noting that while the AMA just published the findings, they are based on surveys conducted during September of 2012, 2014 and 2016 with approximately 3,500 respondents each year — and a lot has happened in value-based care since then.

“We also find evidence that the use of multiple methods to determine physicians’ overall compensation has been on the upswing,” AMA said.

 

10 thoughts from discussion on 2018 Anti-Kickback and Stark Law issues

https://www.beckershospitalreview.com/legal-regulatory-issues/10-thoughts-from-discussion-on-2018-anti-kickback-and-stark-law-issues.html

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We had a chance to moderate and participate in a webinar with leading colleagues John Harig, Tim Fry, David Pivnick and Brett Barnett regarding key Anti-Kickback Statute and Stark Law issues facing health systems, surgery centers, dialysis providers and other healthcare providers and investors. Below are 10 key thoughts discussed during the webinar as to fraud and abuse issues in play in 2018.

1. The reading and implementation of the “Yates Memo” issued by the U.S. Department of Justice will influence how the government aims to prosecute individuals in addition to companies.

2. The reading of the U.S. Supreme Court’s Escobar decision will influence whether defendants in false claims cases will receive some relief from technical billing violations that are not fundamental or material to the government’s paying of a claim.

3. Regulators and potential buyers are focused on “creative marketing arrangements” by physician practices, often related to laboratory and/or pharmacy arrangements.

4. Government enforcement agencies and potential buyers are focused on physician compensation arrangements, particularly their compliance with the Stark Law.

5. Potential buyers face a challenge in determining how deeply to examine targets’ past practices through billing and coding audits, as well as how to handle the results of billing and coding audits in negotiation of transactions.

6. Private equity buyers face challenges in their evaluation of risk posed by regulatory issues and how to address regulatory risks in a seller’s market.

7. Sellers present the historical legal analysis of fraud and abuse issues during the due diligence process, particularly when the legal analysis is positive, but assumptions underlying the legal analysis do not align with the sellers’ actual operations.

8. The turnover in the U.S. Department of Justice may impact the timing of fraud and abuse prosecutions and settlements.

9. Recoveries by the government resulting from fraud and abuse prosecutions have increased in magnitude. Furthermore, there are more recoveries coming from cases in which the government has not joined in the case with the relator.

10. The wide array of laboratory arrangements and businesses hold implications for fraud and abuse laws.