Addressing the challenges behavioral health patients present when in crisis

Access to proper treatment for patients with behavioral and mental health issues has become a major issue in the United States and has received attention from the public and Congress. But, there are unique issues when a behavioral health patient appears at a hospital emergency room and the hospital must abide by the Emergency Medical Treatment and Active Labor Act (EMTALA) (42 U.S.C. §1396dd). Catherine M. Greaves, counsel, and Kristin M. Roshelli of King & Spaulding, LLC addressed the challenges hospitals face in emergency situations with behavior health patients in a Health Care Compliance Association webinar held on July 25, 2017.

The behavioral health patient and EMTALA

When a patient comes to the hospital’s emergency department (ED) with a behavioral health condition and requests emergency treatment, the patient (1) may be a danger themselves or to others, (2) may lack orientation, which is interfering with his or her ability to meet basic needs such as nutrition or safety, or (3) may have an underlying mental illness. Patients may be suicidal or homicidal, assaultive or combative, delusional or psychotic, or experiencing withdrawal from drugs or alcohol.

Hospitals must ensure that EMTALA requirements are met, including conducting a medical screening as well as a psychiatric evaluation, properly stabilizing the behavioral health patient if a n emergency medical condition (EMC) exists, and addressing transfer issues, including the vehicle used to transfer have been addressed. In addition, the hospital must have policies and procedures that adequately reflect EMTALA requirements and must provide education and training on serving behavioral health patients for the ED and other hospital staff, including security. If the hospital is in a state that has laws requiring mental health patients to be evaluated and treated at designated facilities may clash with or be more stringent than EMTALA. Hospitals must not disregard EMTALA requirements.

Concerns specific to behavioral health patients

Greaves said that EDs have become the “de facto dumping grounds for psychiatric patients.” One out of 8 ED visits are for mental health disorders or substance abuse, which represents a large percentage when compared to the population as a whole. In addition, she pointed out a 2008 survey conducted by the American College of Emergency Physicians that found that 99 percent of emergency physicians reported admitting behavioral health patients daily. According to Greaves, much of this is due to the lack of available designated psychiatric hospital beds and the decrease in state facilities for behavioral health patients. Currently, there are only 14 beds available per 100,000 people, which represents a decrease of 90 percent since the 1990’s, and is the number of beds available in 1850. The optimal number of beds is 50 per 100,000.

MSE for behavioral health patients

MSE for behavioral health patients consists of two steps, an initial medical screening to rule out underlying medical/organic causes for symptoms followed by a psychiatric review once medical clearance has been determined. Greaves stressed the importance of conducting the medical screening examination before doing a psychiatric evaluation to rule out medical conditions that can trigger behavioral symptoms. As examples, she noted that drugs and alcohol can mask underlying medical conditions and infections, especially in the elderly, can trigger psychiatric behavior. She also emphasized that appropriate hospital personnel conduct screening.

Stabilization

Greaves noted that patients with behavioral health conditions are not quickly stabilized. Patients must be stabilized enough to tolerate a transfer or be discharged. Hospitals should consider whether the patient is protected and prevented from injuring or harming self or others; when using chemical or physical restraints, and is the underlying EMC stabilized. Although some patients refuse treatment, suicidal patients may not refuse medical and psychiatric evaluations and stabilizing treatment. If the patient is being transferred with restraint for stabilization, how long will the stability last and how long is the trip.

If the ED decides to transfer a patient that is not stable, the physician must explain the reason for the transfer and certify that the benefits outweigh the risk. The transfer, however, must comply with all of the other EMTALA regulations. Within the hospital’s capabilities, treatment must be provided to minimize the risk of harm, the receiving facility that agrees to accept the transfer must be contacted, and appropriate information must be sent to the receiving facility.

Transfer challenges

Behavioral health patients are transferred at higher rates than nonpsychiatric patients with much longer wait times for the transfer because of issues locating an available bed in a national shortage, insurance acceptance and prior authorization delays, and arranging transportation. When it comes to choosing the vehicle to transport behavioral health patients, there is no single method that is full proof. Hospitals should balance minimal interference with the patient’s dignity and self-respect, reduce the likelihood of harm to self or others, and prevent the transport experience from being perceived as a traumatic event.

Options for transportation include ambulance, police care, private vehicle, and a hybrid, but all present problems. An ambulance may not be a good choice because it is filled with objects that can be utilized to harm self or others and there is no barrier to protect the driver. A police car may traumatize the patient, a support person is not allowed, there is no established protocol for safe transport of behavioral health patients, and there is limited ability to intervene if a medical emergency occurs during transport. In addition, both ambulances and police vehicles brings a public cost. Private vehicles should not be used because family are generally not capable of providing appropriate care. Some states laws allow variations that make up a hybrid that may include the involvement of Mental Health Crisis Teams or unmarked police vehicles.

Fraudulent claims submitted to TRICARE for unnecessary medications ends in guilty pleas

In related cases, a pharmacist and pharmacy marketeer, both of Mississippi, pled guilty to conspiracy to commit health care fraud in a scheme that defrauded TRICARE, according to a July 25, 2017, announcement by the Department of Justice (DOJ). The pharmacist and his co-conspirators received at least $192 million in payments for medically unnecessary medications from TRICARE and private insurance companies. In the case of the pharmacy marketeer, TRICARE made payments of approximately $2.3 million for false and fraudulent claims submitted by the pharmacy. Sentencing hearings are scheduled for October 17, 2017.

The pharmacist’s role

The pharmacist pleaded guilty to one count of conspiracy to commit health care fraud and money laundering for dispensing medically unnecessary compounded medications and causing fraudulent claims to be submitted to TRICARE. Plea documents revealed that the pharmacist admitted that he (1) conspired with others to select compounded medication formulas based on profitability rather than on effectiveness or patient need, and (2) conspired with the pharmacy co-owners to avoid fraud prevention measures, such as collecting copayments, to incentivize patients to receive medically unnecessary medications.

The marketeer’s role

The pharmacy marketeer pleaded guilty to one count of conspiracy to commit health care fraud for his role in the scheme to defraud TRICARE. Plea documents indicated that the marketeer admitted to (1) soliciting physicians and other medical professionals to write prescriptions without seeing patients for medically unnecessary compounded medications dispensed by the pharmacy; and (2) conspiring with others to falsify patient records to make it appear as though medical professionals had seen patients prior to the date prescriptions were written.

Senate urged not to proceed with BCRA by civil and human rights groups

One hundred sixty six civil and human rights organizations including The Leadership Conference on Civil and Human Rights, the National Health Law Program, and the National Partnership for Women & Families are urging senators to oppose the motion to proceed on the Better Care Reconciliation Act (BCRA) (H. R. 1628). The organizations sent a letter to senators on July 24, 2017, expressing their concern that the BCRA will “eliminate affordable quality health care for millions of Americans.” Specifically, the organizations said that the BCRA would gut the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and slash federal funding as well as transform Medicaid [funding] into a block grant or per capita cap; and eliminate Medicaid expansion (see ACA sec. 2001 and sec. 1201 of the Health Care Education and Reconciliation Act of 2010 (HCERA) (P.L. 111-152). In addition, the organizations pressed senators to support the Parliamentarian’s ruling excluding the defunding of Planned Parenthood from the bill.

The Senate’s lack of transparency

The organizations noted that they were “seriously concerned about the lack of transparency of the discussions’ that lead up to the introduction of the BCRA and “the rush to vote on the bill without adequate time for analysis, hearings, and a discussion of a CBO [Congressional Budget Office] score.” The organizations stressed that such discussions, would allow the public to better understand the proposed legislation and participate in a discussion of their access to health care.

The impact of the BCRA

The organizations identified the issues that arise from the BCRA provisions that the organizations believe would have a serious impact on the communities that they represent including low-income families and people of color. These issues include:

  • The 15 million people that would lose their Medicaid coverage by 2026 under the revised version of the BCRA, as estimated by the CBO.
  • The repeal of Medicaid expansion, which will disproportionately affect the communities including Latinos, African Americans, Native Americans, Asian Americans, Native Hawaiians, and Pacific Islanders who have seen the largest gains in coverage under the ACA, and women.
  • The proposed cuts that could vastly reduce access to needed health care, reduction in needed services, increased medical debt, and persistent racial disparities in mortality rates.
  • The possible reduction in home and community-based services, which are cost-effective and keep individuals out of nursing homes and institutions.
  • The imposition of a work requirement as a condition of eligibility, which fails to further purpose of providing health care and undermines the objective.
  • The defunding of Planned Parenthood that would prevent more than half of its patients from getting affordable preventive care, including birth control, testing and treatment for sexually transmitted diseases, breast and cervical cancer screenings, and well-women exams.

Vanita Gupta, president and chief operating officer of The Leadership Conference noted that the letter reflects the widespread concerns of people, especially people of color, women, and low-income families, who currently “receive life-saving coverage because of the Affordable Care Act and the expanded Medicaid coverage” but will lose their access to quality affordable health care and will have higher health care costs “if the Republicans succeed.”

Applying lessons learned when conducting FCA investigations after Escobar

The Supreme Court opinion in Universal Health Services v. U.S. ex rel Escobar established that the implied certification theory may be a basis for False Claims Act (FCA) (31 U.S.C. §3729) liability if allegations satisfy both the FCA’s materiality and scienter (knowledge) requirements, Joan W. Feldman, partner at Shipman & Goodwin LLP explained during a Health Care Compliance Association webinar on June 26, 2017. She noted that the focus in FCA cases going forward will be whether the government would have refused to pay the allegedly false claim if it had known of the information allegedly omitted or misrepresented.

The Supreme Court’s opinion and remand

The Supreme Court granted certiorari in Escobar to answer whether the implied certification theory was viable and if it could only apply when a provider violated a legal requirement that the government explicitly designated as a condition of payment. Although the Court determined that implied certification is a valid theory, it stated that the FCA should not be considered a vehicle for “punishing garden-variety breaches of contract or regulatory violations…” The Court further concluded that “a misrepresentation about legal compliance does not become material simply because the Government labeled the legal requirement as a ‘condition of payment,’ but whether the defendant knowingly violated a requirement the defendant knows is material to the Government’s payment decision.” The Court remanded the case to the First Circuit (see Implied certification liability confirmed, limited to material compliance violations, Health Law Daily, June 16, 2016).

Feldman pointed out that upon remand, the First Circuit identified three factors that had to be considered when evaluating materiality and knowledge: (1) was compliance a condition of payment, (2) was compliance with a specific regulation the essence of the agreement; and (3) did the government pay the claim even though it was aware of the issue?

The First Circuit concluded, if Medicaid’s decision to reimburse Universal Health Service would have been unaffected by knowledge of the regulatory violations, the violations would not be material, and the implied false certification lawsuit could not proceed. In this case, however, the complaint stated that regulatory compliance was a condition of payment, licensing and supervision requirements were central to the regulation of mental health treatment facilities generally, and the factual allegations were limited to reimbursement claims filed during treatment (see Implied false certification lawsuit under the FCA stated a valid cause of action, Health Law Daily, November 29, 2016).

Lessons from Escobar

The Escobar case illustrates that the FCA is nuanced and complex, Feldman said. She noted that courts will closely scrutinize and evaluate materiality on a fact specific, case-by-case basis to determine whether the alleged violations are sufficient to constitute a false claim. Although she said it is not clear how the Supreme Court’s opinion will play out in the courts, she stressed the importance of claimants clearly stating their materiality and knowledge claims under the implied certification theory. She also emphasized the importance of reacting appropriately and promptly to FCA complaints or concerns.

Investigations

Feldman provided the details of several steps in conducting an FCA investigation, including where to start, maintaining attorney client-privilege, working with the government, planning and conducting an investigation, and mitigating the risk of a FCA qui tam action. She emphasized the importance of maintaining confidentiality throughout the investigation. In addition, she

  • Where to start. When confronted with a false claim allegation, providers must respond promptly. The date and time that the allegation was made must be documented and the allegation must be communicated to leadership. Legal counsel experienced with false claims should be engaged and the Medicare administrative contractor or Medicaid agency must be notified. The compliance officer must assign responsibility for the investigation but must limit the number of individuals in the sphere of knowledge and communication. Accountability and follow-up are essential as well as the preservation of documents.
  • Maintaining attorney client privilege. Consult with counsel to protect the attorney-client privilege. Ensure document production is done with counsel who creates a privilege log for documents that will not be turned over to the government. Interview witnesses separately to protect communications.
  • Working with the government. When working with the government compliance officers must be cooperative, responsive, and timely; yet maintain an advocate position for the organization. They must understand the issue, facts, and relevant law as well as the settlement if there is one. Feldman encouraged compliance officers not to be intimated by the government or assume its position is correct. She explained that the government only knows the case from the qui tam relator. She told compliance officers to “push back” and advocate the organization’s position with facts and laws when presented with the government’s case.
  • Planning the investigation. An investigative plan must be developed, a timeline created, and records of the investigation must be maintained, including the process, interview notes, and witness log. Witnesses must be identified and interviews must be scheduled.
  • Conducting the investigation. The attorney should conduct the investigation and may have deputized staff to assist. When a complaint of subpoena is received, litigation hold must be communicated throughout the organization. Documents are reviewed and interviews conducted. When appropriate, engage auditors or experts. Leadership should be kept informed throughout the process.

Additional tips

Other advice Feldman provided included circling back to complainant, avoiding whistleblower retaliation, and being mindful of the collateral effect of an investigation on employees. In addition, she emphasized that concerns raised by an individual must be taken seriously. Compliance officers should give them full attention and document the concern and how it was addressed. If the individual is not satisfied with the findings, the compliance officer should document why no further action will be taken and notify counsel. If attention is not given when a concern is raised, the individual may pursue an action.