Editor’s Note: In just the first year of the Trump administration, healthcare faced an avalanche of change. The disputes arising from the flood of new developments encompass both legal and regulatory challenges—and are being played out in both courts and government agencies. Ultimately, they may trigger significant shifts in existing healthcare law. In a recent webinar, Manatt explored the game-changing trends and cases to watch in 2018. In a new series summarizing the program, Manatt examines how the transforming healthcare environment is affecting litigation—and remapping the legal and regulatory landscapes. Last month, in part 1 of the series, we looked at conscience rights and civil rights in healthcare. In part 2, below, we focus on the False Claims Act (FCA) and fraud and abuse enforcement trends.
To download a free copy of the webinar presentation, click here.
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The Current State of Play: Healthcare Fraud Prosecutions Remain a Priority
Despite the uncertainty and divisiveness in the political realm, there is one issue that appears to be bipartisan—the government’s continued focus on prosecuting healthcare fraud. Comments and speeches from government officials, including Attorney General Jeff Sessions and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma, make it clear that the government has made it a high priority to root out fraud in federal programs and recover money lost due to fraud or false claims. Recent activities demonstrate the government’s determination to ferret out and prosecute healthcare fraud.
In June 2016, the Department of Justice (DOJ) announced a nationwide sweep in 36 districts resulting in charges against more than 300 individuals—including 61 doctors, nurses and other licensed professionals—for healthcare fraud schemes, involving $900 million in false billings. In July 2017, the DOJ announced the largest healthcare fraud takedown in history, involving 41 districts; $1.3 billion in false billings; and charges against 400 defendants, including 115 doctors, nurses and other healthcare professionals.
In fact, the DOJ has reported that during the fiscal year ending September 2017, it obtained more than $3.7 billion in settlements and judgments from civil cases that involved fraud and false claims against the government. The majority of that money— $2.4 billion—involved the healthcare industry, including drug companies, hospitals, pharmacies, laboratories and physicians. The DOJ also reported that, in 2017, relators—private individuals who file enforcement actions on behalf of the government—filed 492 lawsuits related to healthcare fraud. The false claims brought by both the government and relators are based on alleged off-label marketing, kickbacks, Stark violations, upcoding, double billing and lack of medical necessity claims.
There’s no question that the DOJ views healthcare fraud as a major drain on Medicare resources. All signs point to the DOJ continuing to target drug companies, hospitals, medical device companies and physician practices. Individuals and smaller physician groups, however, are not immune to efforts to combat fraud and abuse.
Major Enforcement Trends
1. Individual Accountability
Sally Yates became a familiar name in 2017 when, as acting U.S. Attorney General, she announced that the DOJ would not defend President Trump’s immigration and refugee ban. In the healthcare industry, however, Ms. Yates is better known for her memo titled “Individual Accountability for Corporate Wrongdoing,” more commonly called the “Yates memo.” Drafted in September 2015, the memo directed U.S. attorneys to target individual wrongdoers, including corporate executives, involved in corporate crimes. The memo is significant because it directed government prosecutors to focus on individuals, regardless of their ranks or their roles, in cases of corporate wrongdoing. It even included incentives to ensure entities assisted in the government’s efforts to hold individuals accountable.
Although Ms. Yates is no longer serving as U.S. attorney general, her memo is still being followed—and several FCA settlements imposing individual liability have caused healthcare executives to take notice. For example, the owner of Life Care Centers of America paid $145 million to settle allegations that Life Care caused skilled nursing facilities to submit false claims for rehabilitation therapy services. This trend will undoubtedly continue. As current Attorney General Jeff Sessions confirmed in an April 2017 interview, the DOJ is looking forward to charging individuals responsible for corporate misbehavior and mismanagement.
2. Improper Financial Arrangements
Another trend gaining strength is government investigations of improper financial arrangements, particularly violations of the Anti-Kickback Statute and the Stark Law. Several recent examples reflect this growing trend. For example:
- In June 2017, the owners and operators of an acute care hospital in Los Angeles agreed to pay $42 million to settle allegations that they violated the FCA by engaging in financial arrangements with referring physicians in violation of the Anti-Kickback Statute and Stark Law.
- In May 2017, two Southwest Missouri healthcare practitioners agreed to pay the federal government $34 million to settle allegations that they violated the FCA by submitting false claims to Medicare for chemotherapy services rendered to patients referred by oncologists whose compensation was based, in part, on a formula that improperly took the value of their referrals into account.
- In September 2017, Galena Biopharma, Inc., agreed to pay $7.55 million for paying doctors kickbacks to prescribe a fentanyl-based drug. (The physicians who received the kickbacks are in prison following a jury trial.)
3. Combating the Opioid Epidemic
The trend that has received the most press and attention is the government’s focus on combating the opioid epidemic. Pharmaceutical manufacturers and wholesale distributors have recently seen the most activity, with lawsuits filed by almost every state, multiple municipalities and several Native American tribal nations—all seeking to recover funds that they have expended to deal with opioid abuse. Over the past year, the federal government has expanded its focus beyond manufacturers to pursue prescribers and healthcare providers who have submitted claims to federal healthcare programs for opioid prescriptions. These efforts include investigations under the FCA and administrative actions, in addition to traditional criminal actions.
For example, last summer, the DOJ and the U.S. Department of Health & Human Services Office of the Inspector General (OIG) engaged in the largest-ever healthcare fraud enforcement action by the Medicare Fraud Strike Force, involving more than 400 charged defendants in over 41 federal districts. Of those charged, 120 were charged for their role in prescribing and distributing opioids and other dangerous narcotics.
In addition, on August 7, 2017, the DOJ announced the formation of the Opioid Fraud and Abuse Detection Unit. In connection with the Unit’s formation, the DOJ assigned experienced prosecutors in 12 opioid “hotspots”—Alabama, California, Florida, Kentucky, Maryland, Michigan, Nevada, North Carolina, Ohio, Pennsylvania, Tennessee and West Virginia—to focus exclusively on prosecuting opioid-related healthcare fraud. The Attorney General also stated that there would be a surge in Drug Enforcement Administration (DEA) agents and investigators focused on pharmacies and prescribers who are dispensing unusual and disproportionate amounts of opioids.
More recently, on February 27, 2018, the DOJ announced the creation of the Prescription Interdiction and Litigation (PIL) Task Force. Among other things, PIL is tasked with examining state and local government lawsuits against opioid manufacturers to determine what assistance, if any, federal law can provide. With the Trump administration’s public health emergency orders, the government is likely to continue increasing its enforcement activities against opioid abusers.
4. Viability of FCA Cases Alleging Medical Necessity
Finally, another growing trend is FCA cases grappling with the question of objective falsity, particularly in the context of FCA claims where the alleged falsity is premised on a lack of medical necessity in connection with the medical services provided. In these cases, the government or the relator alleges that a provider has violated the FCA by billing the federal government for services that are not medically necessary.
One way to establish that a particular service is not medically necessary is to rely on experts to explain why that service is not a medical necessity. However, several recent cases have ruled that a mere difference of opinion between physicians, without more, is not enough to establish falsity under the FCA. In United States ex rel. Polukoff v. St. Mark’s Hospital et al. (No. 16-cv-00304. 2017 U.S. Dist. LEXIS 8187 (Jan. 19, 2017, D. Utah)), a federal district court in Utah considered whether claims submitted by a physician could be deemed “objectively false” based on alleged noncompliance with industry standards. The court concluded that allegations that a doctor failed to comply with an industry standard for medical care do not satisfy the objective falsity standard and do not render false the physician’s certification that he or she believed that the services were “medically indicated and necessary for the health of the patient.”
In this case, the relator, Dr. Polukoff, alleged that Dr. Sorensen had performed unnecessary medical procedures—specifically, patent foramen ovale (PFO) closures, which are used to close the wall between the two upper chambers of the heart. The relator alleged that Dr. Sorensen and the two hospitals where the procedures were being performed were fraudulently billing the government for costs associated with the PFO closures. The relator argued that PFO closures were reasonable and medically necessary only in highly limited circumstances, such as where there was a history of stroke. Medicare had not issued a National Coverage Determination (NCD) for PFO closures or otherwise indicated circumstances under which it would pay for such procedures. However, the relator attempted to introduce medical guidelines issued by the American Heart Association, as well as physician testimony about the circumstances under which the procedure would have been appropriate.
The defendants, however, moved to dismiss the case for failure to prove that an objectively false claim had been submitted to the government. The court agreed with the defendants, finding that the relator failed as a matter of law to show that the defendants knowingly made an objectively false representation to the government. The court went on to hold that “[o]pinions, medical judgments, and ‘conclusions about which reasonable minds may differ cannot be false’ for the purposes of an FCA claim.”
The court further held that the relator’s assertion that some of the procedures were not reasonable or necessary because they were performed on patients who had not suffered a stroke was a subjective medical opinion that could not be proven objective. The Polukoff case joins several others in rejecting FCA claims premised on lack of medical necessity or other matters of scientific judgment.
FCA Risks in a Managed Care Environment
FCA risks are somewhat different in a managed care environment. In a conventional FCA complaint, a provider has submitted a claim directly either to Medicare or Medicaid, and the relator or the government alleges that the claim was false. For example, the provider may have been alleged to have billed for a service that was not provided or not medically necessary, making the fraud relatively easy to understand.
With so much healthcare in the United States, however, now taking place through managed care, the financial incentives, and therefore the possibilities for fraud, are differently aligned. In Medicare or Medicaid managed care, a private managed care entity receives a fixed capitation payment from the government for each member that it covers. Providers then bill the managed care entity. Therefore, even if a provider is falsely billing a managed care entity, that would not necessarily change how much the government pays.
This does not mean, however, that managed care is immune from FCA litigation. Instead, it means that FCA litigation can be more complex. For example, an increasing number of managed care entities in Medicaid, Medicare and commercial markets are receiving risk-adjusted payments, with managed care plans receiving more money from the government as they enroll sicker patients.
In addition, more and more health plans and providers have contracting arrangements under which they share risk. Therefore, while, traditionally, providers had an interest in billing as much as possible and plans had an interest in reducing billings as much as possible, providers and plans are now more aligned. Both have an interest in managing the utilization of healthcare while also maximizing the revenue that the plan is receiving from the government, since risks and rewards are shared. This can give rise to incentives for providers or plans to improperly make patients appear to be higher risk than they actually may be or to inappropriately limit utilization.
The only significant appellate decision in this area is United States ex rel. Swoben v. United Healthcare Ins. Co. in the Ninth Circuit in 2016. The case was brought against a Medicare Advantage plan and its contracted providers, who had a risk-sharing arrangement with the plan. The allegations included that there had been one-sided, retrospective chart reviews that identified underreporting of diagnosis scores relevant to risk adjustment but ignored overreporting of diagnosis scores.
On a motion to dismiss, the district court had dismissed the FCA case. The Ninth Circuit, however, reversed the district court on the motion to dismiss and ruled that if there were one-sided chart reviews, that would be sufficient to allege an FCA complaint. The allegations against several of the named defendants weren’t specific enough for the case to go forward, however. Instead, the case proceeded only against United, the Medicare Advantage insurer, and one contracted provider group that was specifically alleged to be involved in the retrospective chart reviews.
Health plans and providers looking to the case for guidance on compliance should note that the court was very interested in any indicators there might have been that there were problems with the chart reviews and coding. A high error score on a risk adjustment data validation (RADV) audit can be evidence that it would not be possible in good faith to certify the accuracy of the data. A high RADV score alone, however, should not be enough to allege an FCA violation.
At about the same time as the Swoben case, Universal Health Services v. United States ex rel. Escobar was decided by the Supreme Court. Escobar affirmed that the implied false certification of compliance theory can be a basis for liability under the FCA when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory or contractual requirements that make those representations misleading. In other words, noncompliance could be a basis for an FCA action—but only if that noncompliance is material to whether the provider gets paid.
On remand from the Ninth Circuit, the Justice Department filed a new complaint in intervention, but the district court again dismissed, this time for failure to adequately plead materiality in light of Escobar. While the Justice Department declined to file an amended complaint, a related case has proceeded to district court. In that case, United States ex. rel. Poehling v. UnitedHealth Group, Inc. (C.D. Cal. Feb. 12, 2016), the court dismissed the claims related to the plan’s alleged false certifications of compliance but permitted claims to proceed regarding alleged invalid diagnosis codes that had been submitted.
Takeaways
When submitting data to the government that is going to be the basis for payment, it is critical to be diligent. There is likely to be greater scrutiny in an environment where provider and payer interests are aligned. As a result, there is the need for strong internal compliance programs and audit reviews to ensure that the entity submitting the data is confident in its accuracy—and that any reviews have “looked both ways” to uncover both upcoding and undercoding.
Manatt has conducted compliance reviews of health plans’ risk adjustment and provider contracting processes to identify areas for improvement to minimize these risks. Health plan compliance efforts vary widely. Given increased interest in this area from regulators and plaintiffs, health plan and provider compliance and legal staff should review their processes for risk adjustment, data collection and validation, and plan-provider risk-based contracting.