Category: Alert

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DOJ Settlements Are a Stark Reminder

Arrangements with referring physicians are common in healthcare, but they can be very danagerous if not structured properly. Too often they are used to obfuscate the purpose of payments to physicians.

The Department of Justice for the Eastern District of Michigan announced three civil settlements which serve as good reminders of the types of arrangements that can get providers into trouble:

  • The health system had contracts with several physicians to serve as medical directors, and none of these arrangements satisfied any exceptions to the Stark Law or the AKS, such that referrals these physicians made to the health system violated the False Claims Act.
  • The health system employed a physician and this financial relationship did not satisfy any exception to the Stark Law, such that referrals for designated healthcare services were prohibited and violated the False Claims Act.
  • The health system rented office space to a physician and forgave rent payments, constituting remuneration paid in exchange for referrals from that physician in violation of the AKS and the False Claims Act, and creating a financial relationship that did not meet any exception to the Stark Law, also violating the False Claims Act.
  • The health system permitted a group of referring physicians to secure an equipment lease through non-arm’s-length negotiations, in order to induce referrals of patients from these physicians, in violation of the AKS and the False Claims Act.
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Can Actions Be Considered Remuneration Under the Anti-Kickback Statute?

When discussing the Anti-Kickback Statute (AKS), it’s common to say that “remuneration” can be “anything of value.” That board definition has been called into question by the Sixth Circuit in United States ex rel. Martin v. Hathaway et al., No. 22-1463. In that case, a qui tam relator (physician) alleged that a small-town hospital refused to hire her in exchange for a physician group to continue to send the hospital referrals. The “value” then was the not hiring a physician in exchange for referrals. The AKS does not define “remuneration.”

The Sixth Circuit determined that a careful examination of the meaning of “remuneration” and context shows that this term is limited to “payments and other transfer of value,” not “any act that may be valuable to another.” Thus the act of not hiring the physician is not remuneration.

Further, even if remuneration was present, the court stated that False Claims Act liability “resulting from” an AKS violation requires showing but-for causation. In other words, an FCA plaintiff must show “that the referrals would not have been made without the remuneration, and that the claims would not have been submitted to the government without those referrals.” Here, the qui tam physician was unable to point to any specfic Medicare claims that would not have been submitted as a result of the hospital’s decision not to hire the physician.

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Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

When the public health emergency ends, so do many of the waivers that were created to facilitate healthcare during the pandemic. One such concession involves the The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”).

Generally, the Act provides that no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a medical practitioner to conduct at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. There are seven exceptions, one of which is during a public health emergency.

For the past three years, many telehealth providers have become accustomed to prescribing controlled substances following a telehealth visit, without first conducting an in-person exam.

With the PHE coming to an end in May, an in-person exam will be required. However, the Drug Enforcement Agency (DEA) has proposed rules to that will create additional flexibilities on the timing and manner for obtaining an in-person exam.

Federal Register

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OIG Expands Topics for Frequently Asked Questions

OIG has used various avenues to communicate its views on various healthcare compliance issues, such as advisory opinions, contractor self-disclosures, corporate integrity agreements, and exclusions. In March, the OIG has expanded the number of topics it will consider for FAQs submitted by the healthcase stakeholders:

  1. general questions regarding the Federal anti-kickback statute and the civil monetary penalty (CMP) provision prohibiting certain remuneration to Medicare and State health care program beneficiaries and OIG’s administrative enforcement authorities in connection with these statutes
  2. inquiries regarding the general application of the Federal anti-kickback statute and Beneficiary Inducements CMP to a type of arrangement that may implicate these statutes,
  3. questions regarding compliance considerations, and
  4. OIG’s Health Care Fraud Self-Disclosure Protocol.

More information at Frequently Asked Questions | Office of Inspector General | U.S. Department of Health and Human Services.

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Telehealth Expansion in Texas

The COVID-19 pandemic forced many patients and practitioners to find new ways to connect. The most obvious tool is telehealth, the use of audio-visual platforms to allow practitioners to assess and communicate with patients remotely. Patients and practitioners both were encouraged by how beneficial and flexible telehealth can be. Federal and state governments alike are rushing to loosen restrictions to usher in wider adoption of telehealth tools. The Texas Legislature passed, and Governor Abbott signed, two telehealth bills that aim to provide greater access to care with telecommunication technology.

SB 40 expands the Texas Occupations Code to make permanent certain waivers granted by Gov. Abbott during the pandemic. For practitioners regulated by the Texas Department of Licensing and Regulation (TDLR), the definition of “direct” patient observation now allows the use of telehealth platforms. It also allows TDLR to adopt rules governing telehealth services that are provided by its regulated professionals.

HB 4 expands the Government Code and the Health and Safety Code to give practitioners more flexibility to use telehealth services with Medicaid, CHIP, and other public benefit program recipients. Health and Human Services Commission (HHSC) is tasked with implementing greater telehealth integration by the end of this year. Medicaid Managed Care Organizations (MCOs) are granted greater flexibility to conduct assessments and provide coordination of care services through telecommunication technology. Rural access hospitals and federally qualified health centers (FQHCs) are also eligible for reimbursements of telehealth fees.

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Hospice, home health agency and owners pay over $1.8M to resolve claims concerning physician payments

The founders of an Edinburg hospice and related home health agency have paid to resolve allegations they submitted claims to Medicare that resulted from unlawful referrals.

Onder Ari, 49, Edinburg, and Sedat Necipoglu, 48, McAllen, founded Allstate Hospice LLC and Verge Home Care LLC. They and their companies have now paid $1,847,279.36 following an investigation into improper payments to physicians for referrals.

Ari and Necipoglu offered compensation to physicians who were responsible for a significant majority of their patient referrals. Specifically, they provided physicians with monthly payments pursuant to medical directorship agreements with Allstate and Verge. Those payments were in excess of fair market value for the services the physicians actually provided. They also sold interests in Allstate to five different physicians which ultimately netted them substantial quarterly dividends. They also provided physicians other gifts and benefits, such as travel and tickets to sporting events.

Source: Hospice, home health agency and owners pay over $1.8M to resolve claims concerning physician payments

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2020 Health Antitrust Year in Review

The federal antitrust enforcement agencies brought three hospital merger challenges and three criminal antitrust enforcement actions in health care in the past year. Combined with the incoming Democratic administration, healthcare antitrust enforcement is likely to remain strong in 2021.

Hospitals & Health Systems. The Federal Trade Commission (FTC) challenged three hospital and health system transactions in 2020. While the outcome of the most recent challenged transaction is pending, in one of the other two transactions, the merging parties abandoned the deal after the complaint was filed, and in the other transaction the district court refused to grant a preliminary injunction to cease consummation of the transaction pending an administrative trial. Other than various strategic, cost, timing, and business reasons for why parties choose to defend a transaction or not, and the difference in case development, what lessons can be drawn from these recent enforcement actions? First, payor views—and the substantiation thereof—remain key. Parties to proposed in-market transactions should carefully analyze their historical contracting practices and network configuration. Second, geographic market definition has always been and remains critical to the antitrust analysis of these transactions, particularly in urban areas. Relevant geographic markets are analyzed first by the impact a merger may have on insurers, and second by the merger’s potential impact on patients. Detailed economic analysis is part of antitrust due diligence in preparation for proposed transactions.

Payors. If finally approved by the court, the proposed Blues plans’ subscriber settlement may change the competitive dynamic in the healthcare services insurance markets. Employers would be able to request bids from and providers may negotiate rates with multiple insurance providers even under the same umbrella. Insurance licensees may be able to make inroads into new markets and offer new products.

Criminal Enforcement. The Department of Justice (DOJ) has brought several criminal charges against healthcare companies in the past couple of months, including for wage-fixing, nonsolicitation/nopoach agreements and market allocation. General counsels (GCs) and human resources (HR) professionals should emphasize company-wide training and familiarity on how the sharing of nonpublic wage and employment term information with competitors can lead to antitrust violations for individuals as well as the company. Enforcement agencies, as well as private plaintiffs, can challenge agreements as anticompetitive irrespective of whether they challenge any underlying transaction. The federal government and state AGs are ramping up criminal enforcement in healthcare markets. Healthcare organizations should consider their internal corporate compliance programs and education.

Vertical Mergers. In analyzing the potential harm of a vertical transaction, the antitrust enforcement agencies will ask whether the parties, after they have merged, will have the ability or incentive to foreclose rivals. For example, if a hospital system acquires an ambulatory care provider in the same geographic area, a key inquiry would be whether the merged entity will have the ability to force payors into an exclusive arrangement that limits the payors’ ability to contract with other hospitals or ambulatory care providers. Another relevant question is whether the merged entity would have the ability to cherry-pick profitable cases and refer less profitable cases to other entities. In a vertical merger between an insurer and a pharmacy, a key concern would be whether insurer enrollees could use only the payor’s pharmacy, or have to pay higher fees to use a different pharmacy. Parties to vertical transactions should engage in antitrust planning to assess potential competitive effects.

Federal and State Policy & Enforcement. With Xavier Becerra nominated to Secretary of the Department of Health and Human Services (HHS), states pursuing antitrust enforcement in the provider marketplace will be likely to receive support (e.g., briefs, public statements, parallel federal enforcement actions) from the federal government. Moreover, the injunctive relief included in the settlement terms of a lawsuit Becerra joined as California Attorney General could very well lead states to pass tighter transparency regulations and price controls. Providers should examine their ordinary course and post-closing managed care contracting practices.

Source: 2020 Health Antitrust Year in Review – McDermott, Will and Emery.

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Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement actions within the past year. And there are more to come.

These prosecutions involve providers billing federal healthcare programs for acupuncture using P-Stim devices under HCPCS Code L8649. Unlike P-Stim devices, though, which are attached to the ears of a patient using needles and adhesives without surgery or anesthesia, HCPSCS Code L8649 applies to a product that is surgically implanted into a patient using anesthesia. Medicare, TRICARE and the Federal Employees Health Benefit Program (FEHBP) do not reimburse for acupuncture devices like P-Stim, nor do they reimburse for P-Stim as a neurostimulator or an implantation of neurostimulator electrodes. In addition to P-Stim, the brand names for these devices include ANSiStim, E-pulse, Stivax and NeuroStim.

Source: Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

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Texas Company Agrees to Reimburse Medicare for Improper Billing Related to Neurostimulators

Spinal Decompression Clinic of Texas (“SDCT”) has agreed to pay $330,898.00 to resolve liability under the False Claims Act for the alleged improper billing of electro-acupuncture device neurostimulators.

SDCT received reimbursement from Medicare in the amount of $177,051.15 for these procedures. SDCT, however, did not perform these surgeries, and instead applied P-Stim devices in an office setting, without surgery or anesthesia. P-Stim is an electric acupuncture device that, pursuant to manufacturer’s instructions, is affixed behind a patient’s ear using an adhesive. Needles are inserted into the patient’s ear and affixed using another adhesive. Once activated, the device then provides intermittent stimulation by electrical pulses. It is a single use, battery-powered device designed to be worn for approximately four days until its battery runs out, at which time the device is thrown away.

Medicare does not reimburse for acupuncture or for acupuncture devices such as P-Stim, nor does Medicare reimburse for P-Stim as a neurostimulator or as implantation of neurostimulator electrodes.

Source: Texas Company Agrees to Reimburse Medicare for Improper Billing Related to Neurostimulators

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New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act’s Defenses in Non-Use Situations

The US Department of Health and Human Services (“HHS”) issued an Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete preemptive federal jurisdiction and invites jurisdictional discovery; and (2) applies to cases where the alleged harm results from failure to use (and even refusal to use) a covered countermeasure when that failure arises out of the conscious allocation and prioritization of the countermeasures.

Advisory Opinion 21-01 expands on the language of the amended Declaration to clarify that the PREP Act provides complete preemptive federal jurisdiction for cases in which it is a defense. Once invoked, the PREP Act provides complete preemptive federal jurisdiction, and the federal court retains the case to decide whether the immunity and preemption provisions apply; if they do not apply, then the court would try the case as it would a diversity case.

Advisory Opinion 21-01 further clarifies that the PREP Act protections apply in cases where the complainant alleges harm from the defendant’s complete failure—or even refusal—to use covered countermeasures, particularly in those cases where such a failure arises from the conscious allocation of scarce resources among potential countermeasure recipients.

Source: New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act’s Defenses in Non-Use Situations