South Dakota Federal District Court Allows Medical Device Kickback Suit to Proceed Against Surgeon

Back in October of 2019, the hospital entities of Sanford Health, Sanford Medical Center and the Sanford Clinic in Sioux Falls South Dakota agreed to pay $20.25 million to resolve False Claims Act (“FCA”) allegations. The settlement is one of the largest in the United States District Court for the District of South Dakota. Last week, the U.S. District Court for the District South Dakota found that the lawsuit filed against the neurosurgeon who worked for Sanford- which alleged that he violated the FCA by engaging in a kickback scheme to order medical devices used in surgeries from two companies he owned- could proceed.

This case is representative of a growing area of concern with respect to addressing possible fraudulent conduct in connection with the delivery of healthcare services vis-a-vi the Physician Owned Distributorship (POD). The Department of Health and Human Services defines a POD as any physician-owned entity that derives revenue from selling, or arranging for the sale of, implantable medical devices and includes physician-owned entities that purport to design or manufacture, typically under contractual arrangements, their own medical devices or instrumentation. This business arrangement in which physician investors form companies that purchase medical devices from third-party manufacturers and sell them to hospitals, often to the hospitals at which the POD physician-investor practices is exactly what happened with the defendants in this case.

Defendant Dr. Wilson Asfora is a neurosurgeon and the owner of Medical Designs LLC and Sicage, LLC. Dr. Asfora ordered and used devices manufactured and sold by Medical Designs and Sicage in the surgeries he performed at Sanford Medical center. As the owner of Medical Designs and Sicage, Dr. Asfora profited from the sales of these devices in violation of the False Claims Act. The claims allegedly were false because they were made in violation of the Anti-Kickback Statute and in connection with surgeries that were medically unnecessary. Thus the very essence of a POD can easily implicate the Anti-Kickback Statute, which prohibits “knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe, or rebate) directly or indirectly. . . in cash or in kind, in exchange for or inducing another to refer an individual to particular goods or services for which payment may be made in whole or in part under a federal health care program.”
Given the context of the global pandemic, it is imperative that health care professionals and medical device companies, that are critical to innovation and improving patient care, engage in transparent and ethical ways. The business relationship implicated between a hospital and a POD where a physician is the owner of the POD can corrupt the medical judgment of the physician, just as Dr. Asfora’s financial interest in the medical devices he implanted in patients corrupted his medical judgment. Moreover, because the anti-kickback statute assigns criminal liability to parties on both sides of an impermissible kickback transaction- hospitals, as well as ambulatory surgical centers (ASCs) that enter into contracts with PODs also may face liability.

Hospitals and ASCs should note that the risk of fraud and abuse is particularly high in circumstances when such physicians-owners are one of the few users of the devices sold or manufactured by their PODs. The Department of Health and Human Services issued a policy statement announcing enforcement discretion over COVID-19 anti-kickback violations for certain circumstances involving other provider types but expressly indicated that they would not extend that enforcement posture policy towards medical devices. Thus, the federal government continues to aggressively pursue medical device companies for violating the anti-kickback statute during the COVID-19 epidemic.

VW Contributor: Skylar Young
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Integrated HRAs

A new option exists for employers when it comes to paying for employee health care coverage. On June 13^th, the U.S. Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued a final rule allowing employers to use pretax dollars to subsidize employee premiums in the individual health insurance market. Now, employers of all sizes that do not offer a group coverage plan can fund a new health reimbursement arrangement (HRA) known as individual coverage HRA (ICHRA).

Previously, under the Affordable Care Act, employers were prevented from offering stand-alone HRAs that would allow an employee to purchase coverage on the individual market. That has changed. Employers now have the option to provide their workers and their families with tax-preferred funds to pay all or a portion of the cost of coverage that workers purchase in the individual market. The departments posted an FAQs regarding the new regulation. ICHRAs are advantageous to employers because they maintain the tax favored status that apply to a traditional group health plan. Additionally, another employer-sponsored insurance called Excepted Benefit HRAs (EBHRA) allows employers to finance an additional pretax $1,800 per year to reimburse employees for certain qualified medical expenses (such as premiums for vision and dental insurance) even if the employee opts out of enrollment in the traditional group plan.

Qualified Small Employer HRAs (QSEHRA) are still an attractive alternative to group coverage for smaller employers- those with fewer than 50 full-time employees. Under QSEHRAs, employers can give their employees money tax-free to purchase individual health policies through the ACA exchange, similar to ICHRAs. Employees can use these funds to pay all or part of the insurance plan premium or pay for out-of-packet medical costs. While ICHRAs are void of caps on annual allowance amounts, in 2019, QSEHRAs allowance amounts were capped at $5,150 for self-only employees and $10,450 for employees with a family. While ICHRAs are free of caps, employees who choose ICHRAs will not be able to receive any premium tax credit/subsidy for exchange-based coverage. In some instances, if an employer funds an ICHRA or a QSEHRA coupled with individual-market insurance, this will bar the individual-market coverage from becoming part of the Employee Retirement Income Security Act (ERISA).

If employers choose to offer ICHRAs, then the new regulations require a written notice be issued to all employees who are eligible. In this notice, employers need to include a provision that states the ICHRA may make them ineligible for a premium tax credit or subsidy when buying an Affordable Care Act exchange-based plan. ICHRAs will be available for plan years starting on or after January 1, 2020. Employers offering an ICHRA with a plan year that begins on January 1, 2020 should help eligible employees understand that they must enroll in individual health insurance coverage during the open enrollment period, November 1, 2019 through December 15, 2019, for individual health insurance coverage that takes effect on January 1, 2020.

ICHRAs and EBHRA are two new health insurance arrangements that could provide smaller employers with innovative and more cost-effective ways to finance worker health insurance coverage. The IRS has noted that including safe harbor provisions to ensure employers still satisfy the ACA’s affordability and minimum value requirements with ICHRAs will come out later this year.

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U.S. Healthcare System Faces Mounting Cybersecurity Risks

The heightened use of technology in healthcare is coupled with mounting cyberattacks. Recently, the healthcare industry experienced a global cyberattack when malicious software targeted the industry. The attack hit Britain’s National Health Service the hardest, affecting sixty-five of its hospitals. Cyberattackers stole healthcare information after using phishing emails to take control of the organizations’ computers, encrypting the computers’ information, and threatening to release the patient information contained on the systems if the organizations failed to satisfy payment demands.

According to the U.S. Department of Health and Human Service’s Office for Civil Rights, over 100 million Americans’ health records were divulged in 2015. In early 2017, Experian predicted the health care industry would be the biggest target for an attack. Moreover, an Identity Theft Resource Center report revealed that more than 25% of all data breaches occurred in the healthcare industry, costing an estimated $5.6 billion each year.

Congress created the Health Care Industry Cybersecurity Task Force through the Cybersecurity Act of 2015 to examine the healthcare industry’s vulnerabilities and create solutions to the cyber threats that place millions of patients’ information at risk each year. In light of the recent attack, the task force investigated the state of health information systems security in the U.S. and found a desperate need to increase health IT security.

In its report to Congress, the task force made a series of recommendations that suggested how to fend off the increasing threats. Among others, the recommendations include creating programs to cleanse healthcare organizations of vulnerable hardware and software and inserting more people with security skills into the healthcare field. The report emphasizes that failure to intervene could lead to catastrophic losses for organizations and patients.

The task force notes that the successful implementation of its recommendations will require significant time and resources, but it hopes the government will promptly respond to its report with efforts to improve cybersecurity in healthcare organizations.

The task force notes that the successful implementation of its recommendations will require significant time and resources, but it hopes the government will promptly respond to its report with efforts to improve cybersecurity in healthcare organizations.

 

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Final Regulations Issued for Non-Discrimination in Health Programs

Section 1557 of the Patient Protection and Affordable Care Act (ACA) allows the Secretary of Health and Human Services (HHS) to issue regulations pertaining to non-discrimination. Earlier in May of 2016, the Secretary of HHS issued such regulations, which bans the denial of healthcare or health coverage to individuals on the basis of race, color, national origin, sex, age, or disability.

This final rule, the first federal civil rights law that broadly prohibits discrimination on the basis of sex, applies to any federally funded health plan. Although the law prohibits discrimination based upon sex, HHS failed to fully define certain issues, such as whether this covers discrimination based upon sexual orientation. However, HHS’s Office for Civil Rights (OCR), the agency tasked with enforcement, has stated an intention to review all claims in this area to determine whether the discrimination can be addressed under the regulations.

This rule will become effective on July 18, 2016, and will be enforced by OCR. Although OCR is tasked as a primary regulator, compliance burdens will fall to all entities covered by the new regulations, as well as individual citizens because the regulations include a private right of action for violations. Further details can be found at the following link. https://federalregister.gov/a/2016-11458

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Nebraska Legislature Adopts Stronger Prescription Drug Monitoring System

by M. Tom Langan, II

A recently adopted law in Nebraska calls for the state to create a prescription drug monitoring system designed to help prevent the misuse of controlled substances, namely prescription pain medicine.  The system will require physicians and pharmacists to enter into a database patient information when prescribing and dispensing certain medications. Patients are not allowed to opt out of the database. A goal is to help prevent so-called “doctor-shopping” – or when a patient visits multiple doctors to obtain multiple prescriptions.

Physicians and pharmacists should be aware that the system is required to be implemented by January 1, 2017.

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New Nebraska Law Creates Mandatory Reporting of Controlled Substance Prescriptions for 2017

The over-prescribing of an opioid drug can create significant criminal and civil liability for a prescriber, as illustrated in the recent People v. Tseng decision and the proposed $1.1 billion White House initiative to combat prescription opioid and heroin abuse. To aid physicians and prescribers in controlling prescription opioids, every state, with the exception of Missouri, authorized a prescription drug monitoring program (PDMP).

The PDMP collects information on the prescription of controlled substances, but the specific substances monitored will vary state by state. Usually, however, it will be a mix of drugs considered controlled substances under state and federal law. The information stored in the database is accessible only by certain individuals, such as pharmacists, physicians, and other prescribers. The goal is to provide information about patient prescriptions to those with prescribing power, to ensure that over-prescribing of drugs, such as opioid drugs, does not occur.

In Nebraska, the PDMP was established by law in 2011, but the system was not truly implemented at that time. Until a February 2016 law, prescriber participation was not required and, regardless, the system was not truly operational. Moreover, until the 2016 law, patients that paid via Medicare or cash could opt-out of participation, removing a significant population of patients. However, the new law requires that all prescriptions of controlled substances be reported by the prescriber, starting January 1, 2017. Similarly, all prescription information, including patient information, must be reported to the PDMP starting January 1, 2018. The new law also eliminates the previous loopholes for patients to opt-out of the reporting requirements. Notably, however, the prescriber does not have an obligation to check the system prior to prescribing a controlled substance, such as an opioid drug, but they will have free access to check the PDMP. Of course, the Dr. Tseng decision highlights the potential for either criminal or civil liability for over-prescribing.

To see further information on the Dr. Tseng decision, please visit: https://vwhealthlaw.wordpress.com/2016/02/19/new-criminal-precedent-for-physicians-over-prescribing-opioid-drugs/

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New Criminal Precedent for Physicians Over-Prescribing Opioid Drugs

In October of 2015, a jury convicted a physician of second degree murder for over-prescribing a drug that resulted in a fatal overdose for three patients. People v. Tseng is the first conviction of a physician for murder due to over-prescribing, but the Centers for Disease Control and Prevention note that physicians are a significant contributor to the 17,000 plus opioid overdose deaths a year.

After the conviction, in February of 2016, Dr. Tseng was sentenced to 30 years to life in prison for the fatalities due to over-prescription. Although this was the first conviction of its kind, the prosecution of physicians for reckless or intentional over-prescription of certain types of drugs is significantly increasing. An example of the new focus, early in 2016, the White House proposed a $1.1 billion initiative to combat the prescription opioid and heroin use problem.

In the Tseng conviction, the physician had prior incidents of over-prescribing and all three individuals purposefully sought her out for the prescriptions. While she maintains that she was relatively untrained in opioid based prescriptions, thus leading to the over-prescribing, she is not eligible for parole for 30 years.

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IRS issues final regulations on employer sponsored health insurance

In December of 2015, the Internal Revenue Service (IRS) issued final regulations that addressed some of the questions pertaining to whether employer sponsored health insurance meets the Patient Protection and Affordable Care Act minimum value requirements.  Amongst a variety of miscellaneous items pertaining to minimum value, the final regulations clarify the impact of a health reimbursement arrangement (HRA) on affordability. The regulations also clarify some of the rules regarding eligibility for the health insurance premium tax credit.

Under the final regulations, the new amounts made available by an employer to an employee in a HRA that can be used to pay health insurance premiums, when the employer also offers qualifying health coverage, will be counted towards affordability. Similarly, if the new amounts are available to an employee in a HRA integrated with qualified employer coverage, and the new amount can only be used to reduce cost-sharing, that new amount will be counted for minimum value purposes.

The health insurance premium tax credit had rules finalized in the same regulations. One rule includes the eligibility of a household that has income from a child. The premium tax credit is based on household income and when a parent includes a child’s income on their income tax return for tax credit eligibility purposes, the amount used is the child’s modified adjusted gross income, not the gross income reported on the child’s tax return.

The final regulations also addressed the impact of wellness incentives on the health insurance premium tax credit. The regulations clarify that wellness incentives that reduce the cost of health insurance premiums to an employee will not be included in the calculation for minimum value or affordability, instead the regulations assume the employee will not qualify for the incentive. This rule has one exception, which is if the incentive is based on tobacco use. If so, the regulations assume that the employee will qualify for the incentive and the incentive can be used in the minimum value and affordability calculation. Thus, only tobacco use wellness incentives can be used in the minimum value and affordability calculation for purposes of premium tax credit eligibility.

Overall, a variety of miscellaneous rules regarding health insurance were finalized in the regulation. The entirety of the IRS regulation can be found at the following link: https://www.federalregister.gov/articles/2015/12/18/2015-31866/minimum-value-of-eligible-employer-sponsored-plans-and-other-rules-regarding-the-health-insurance

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Physician Conflict of Interest Reporting Requirements

The Physician Payments Sunshine Act was adopted as part of the Patient Protection and Affordable Care Act in 2010. The act allows patients to know if their physician may have an outside motivation when providing care, such as incentives provided by medical product manufacturers. These incentives could include simple monetary payments or any type of transfer of valuable goods. By making this information public, the hope is to ensure that physicians make the best possible decisions for their patients, not their own personal interests.

The Act requires physicians to disclose to the Centers for Medicare and Medicaid Services (CMS) any payment or “transfer of value” made to the physician or teaching hospital by a medical product manufacturers. This Act also requires a group purchasing organization or medical manufacturer to disclose any physician ownership. The information is then published online for patients and others to research, with the first set of data published in 2014. Despite the initial publication, CMS withheld some information due to technical difficulties and the outcome of this publicity remains unclear. For 2015 and 2016, CMS implemented changes to the reporting process for physicians as a result of the first release.

Despite the lack of clarity surrounding the outcome of making this information public, some lawmakers are trying to expand the law to include nurse practitioners and others that have prescribing authority. However, at the current time, the law remains limited to physicians, medical product manufacturers, and group purchasing organizations. To view the information and search for physicians, please visit the following website: https://www.cms.gov/openpayments/

© 2015 Houghton Vandenack Williams
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Healthcare Organization Boards’ Responsibilities for Compliance Plan Oversight

The governing board of any health care organization has critical oversight responsibilities for the organization’s compliance plan.  To help boards meet these responsibilities, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has issued a new practical guide outlining health care boards’ compliance obligations.   The guide, entitled “Practical Guidance for Health Care Governing Boards on Compliance Oversight” was created by the OIG in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA).

While not intended to set particular standards of conduct, the guide attempts to provide practical guidance to help governing boards of health care organizations understand and address their compliance responsibilities.   The guide emphasizes the practical, with sections on the OIG’s expectations for board oversight of compliance programs and the interrelationship of audit, compliance and legal functions.  The guide also addresses mechanisms for identifying risks and reporting issues to the board, along with methods of encouraging accountability to achieve compliance objectives.

Although not every compliance measure addressed in the guide may be appropriate for every organization, every board may benefit from additional insight to the regulators’ compliance expectations.  The guide can be found at the following link: https://oig.hhs.gov/compliance/compliance-guidance/docs/Practical-Guidance-for-Health-Care-Boards-on-Compliance-Oversight.pdf

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