by Elizabeth E. Hogue, Esq. | Jan 31, 2024 | Admin, Regulatory
by Elizabeth E Hogue, Esq.
Providers may have heard or read about the importance of Fraud and Abuse Compliance Plans in their organizations. Despite the wealth of available information about Compliance Plans, many providers continue to express uncertainty about their value. Here are some of the questions providers commonly ask about Compliance Plans:
Why should we have a Fraud and Abuse Compliance Plan?
First, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has clearly stated that, consistent with the Affordable Care Act (ACA) as described below, all providers are now expected to have current Compliance Plans that are fully implemented.
As a practical matter, when providers establish and maintain Compliance Plans, it clearly discourages regulators from pursuing allegations of fraud and abuse violations.
Technically speaking, the Federal Sentencing Guidelines make it clear that establishment and implementation of Compliance Plans is considered to be a mitigating factor. That is, if accusations of criminal conduct are made, the consequences may be substantially less severe because of a properly implemented Compliance Plan.
In addition, providers with Compliance Plans are more likely to avoid fraud and abuse. This is because Plans routinely establish an obligation on the part of every employee to report possible instances of fraud and abuse, and Plans include training for all employees.
Compliance Plans may help to prevent qui tam or so-called “whistleblower” lawsuits by private individuals, rather than by government enforcers, who believe that they have identified instances of fraud and abuse. There are significant incentives to bring these legal actions since whistleblowers receive a share of monies recovered because of their efforts. Some whistleblowers have received millions of dollars. Compliance Plans make it clear that employees have an obligation to bring any potential fraud and abuse issues to the attention of their employers first. Compliance Plans provide a clear path to resolve fraud and abuse issues internally.
In addition, the federal Affordable Care Act (ACA) requires providers to have Compliance Plans. In short, it’s the law!
Finally, the Deficit Reduction Act (DRA) requires providers who receive more than $5 million in monies from state Medicaid Programs per year to implement policies and procedures, provide education to employees, and put information in their employee handbooks about fraud and abuse compliance. These requirements can be met through implementation of Fraud and Abuse Compliance Plans.
We don’t receive reimbursement from the Medicare or Medicaid Programs. Do we still need a Compliance Plan?
Statutes and regulations governing fraud and abuse also apply to providers who receive payments from any federal and state healthcare programs, including Medicaid, Medicaid waiver and other federal and state health care programs, such as TriCare and the VA. Many private insurers have followed the federal government’s lead in terms of fraud and abuse enforcement. Therefore, providers that don’t receive reimbursement from the Medicare Program must have compliance plans, too.
We hear that the OIG of the U.S. Department for Health and Human Services has provided guidance for various segments of the healthcare industry regarding Compliance Plans.
- Specifically, the OIG has already published guidance for clinical laboratories, hospitals, home health agencies, hospices, physicians’ practices, third-party billing companies, and home medical equipment companies. Should we just use the model guidance that is applicable to us?
The answer is, “No!” Guidance from the OIG is not a model Compliance Plan. Guidance from the OIG consists of general guidelines and does not constitute valid Compliance Plans. In addition, the OIG has made it clear that Plans must be customized for each organization.
We have read that, before implementing Compliance Plans, providers must conduct expensive internal audits that can take many months to complete. Is this true?
While beginning the compliance process with an extensive internal audit is certainly one way to proceed, it is not the only viable way to work toward compliance. It is equally valid to begin with Compliance Plans that are customized for the organization and include training for all employees about fraud and abuse, and Compliance Plans. Then all staff members can subsequently participate in internal compliance activities, including audits, with a process in place to handle any issues that arise as a result of the audits.
We have all sorts of policies and procedures in our organization. Why do we need something else called a Compliance Plan?
Compliance Plans are specific types of documents that routinely address fraud and abuse issues that providers do not usually cover in internal policies and procedures. In addition, providers may not gain benefits under the Federal Sentencing Guidelines described in paragraph one (1) above if there is no formal document called a Compliance Plan.
We just spent a lot of money to become accredited or reaccredited. Doesn’t certification mean that we are in compliance?
On the contrary, Compliance Plans appropriately address potential fraud and abuse issues. They also include mechanisms for helping to ensure compliance, such as processes for identification and correction of potential problems that are not addressed during the certification process. In other words, organizations may be accredited, but fail to meet applicable compliance standards for fraud and abuse.
Will the fact that our organization has a Compliance Plan make any difference regarding the outcome of fraud and abuse investigations and the imposition of Corporate Integrity Agreements (CIA’s)?
Yes, it may make a considerable difference, based on statements from the OIG. If providers have Compliance Plans in place during investigations that are current and fully implemented, the OIG may be less aggressive in pursuing potential violations. Enforcers are likely to ask for information about Compliance Plans and related policies and procedures. Enforcers are now also likely to ask providers to show them how much money they have spent on fraud and abuse compliance activities!
When the OIG discovers problems with fraud and abuse in organizations, providers are usually asked to develop and implement a Corporate Integrity Agreement (CIA). The OIG often requires CIA’s to include a process for stringent monitoring by the OIG on a continuous basis. These monitoring activities can be extremely burdensome to providers in terms of both time and money. Providers with valid Compliance Plans may not be asked to develop and implement CIA’s.
Now is the time for all providers to recognize and act upon the need to establish and maintain Compliance Plans. “Working on it” is no longer good enough.
©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Nov 8, 2023 | Clinical
Untitled Document
by Elizabeth E. Hogue, Esq.
Joyce Grayson, a home health nurse for Elara Caring, was murdered on October 28, 2023, in the home of a patient where she was providing services. Ms. Grayson was reported missing by a family member to the local police department. The family member was also able to track her last location to the home of a patient she was scheduled to visit at 8:00 a.m. on the day of her death. The patient resided at a halfway house for convicted sex offenders. Police have not yet formally identified a suspect in Ms. Grayson’s death.
This horrible news reminds of steps that staff members and providers can take to protect their staff members:
- Staff members should be sure of the locations of patients’ homes and have accurate directions. · Employees should contact their supervisors in the event of threatening circumstances.
- During visits, employees should remain alert and watch for signs of possible violence; such as verbal expressions of anger and frustration, threatening gestures, signs of drug or alcohol use, or the presence of weapons.
- When employees are verbally abused in patients’ homes, they should ask the speaker(s) to stop. If verbal abuse continues, caregivers should leave patients’ homes and notify their supervisors that they have done so. · If possible, caregivers should identify more than one exit from patients’ homes and keep a clear path to at least one of them.
- All employees should read or reread The Gift of Fear by Gavin de Becker and take action when their instincts tell them that they should be fearful. · Management should develop a written policy of “zero tolerance” for all incidents of violence, regardless of source. The policy should include animals! The policy must require employees and contractors to report and document all incidents of violence, no matter how minor. Emphasis should be placed on both reporting and documenting. Employees must provide as much detail as possible. The policy should also include “zero tolerance” for visible weapons when caregivers are present in patients’ homes. Caregivers must be required to report the presence of visible weapons.
- Agencies should develop quality indicators that improve efforts to protect staff. Indicators in quality and safety standards should include patient assault and other instances of violence or threatened violence. The results of these indicators should result in violence prevention plans and training programs in de-escalation of violence.
- Data systems should be strengthened to monitor the exposure of staff members to aggression. More resources should be invested in measuring aggressive events and specific factors that resulted in exposure, such as patient type.
- Ongoing education should be provided to protect staff. Education should focus on intentional actions that staff members must take to recognize, document, and counter threatened or actual violence.
The Connecticut General Assembly recently passed a law to increase protection for healthcare workers that does not include home care providers. Now lawmakers are calling for extension of the legislation to include home healthcare staff. Martin Looney, President Pro Tempore of the Connecticut State Senate told the CT Mirror: “More and more care is going to be provided in a home setting, which is generally a good thing. But if that is true, we need to make sure that the people who are providing that care are safe.”
Amen to that, Mr. Looney! Let’s get to it!
©2023 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
by Elizabeth E. Hogue, Esq. | Jul 12, 2023 | CMS, Regulatory
by Elizabeth Hogue, Esq.
For providers to be liable under the federal False Claims Act, enforcers must prove that they knowingly submitted false claims. The U.S. Supreme Court recently issued an opinion in United States ex rel. Schutte v. SuperValu, Inc. [No. 21-1326 (U.S. June 1, 2023)], which defines what “knowingly” means. The Court decided that providers act knowingly depending on their “culpable state of mind” when they submitted alleged false claims; not what providers may have thought after submitting them. The requirement to prove knowledge, or “scienter,” said the Court, refers to providers’ knowledge and subjective beliefs; not to what objectively reasonable persons may have known or believed.
On June 30, 2023, the U.S. Supreme Court issued orders that revive two whistleblower lawsuits based on the opinion described above. Specifically citing the above decision, the Court granted whistleblower Troy Olbausen’s request to hear his case. The Court then vacated an Eleventh Circuit decision that dismissed Olhausen’s whistleblower lawsuit.
The Eleventh Circuit previously dismissed Olhausen’s suit against Arriva Medical because he could not prove that the defendants had knowledge of their submission of false claims in view of their objectively reasonable interpretation of the Medicare rules in question. The Supreme Court sent the case back to the Eleventh Circuit for further consideration based on its decision in Schuttte v. SuperValu, above [Olhausen v. Arriva Med., LLC, No. 22-374 (U.D. June 30, 2023)].
Likewise, on June 30, 2023, the Supreme Court sent a case back to the Fourth Circuit for further consideration in light of the Schutte case.
These actions make it clear that the new standard set by the Supreme Court in the Schutte case will make a difference in cases based on the federal False Claims Act. The Court said in the Schutte case:
“Both the text and the common law also point to what the defendant thought when submitting the false claim – not what the defendant may have thought after submitting it…As such, the focus is not, as respondents would have it, on post hoc interpretations that might have rendered their claims accurate. It is instead on what the defendant knew when presenting the claims…Culpability is generally measured against the knowledge of the actor at the time of the challenged conduct.”
The Court also said:
“Under the FCA, petitioners may establish scienter by showing that respondents:
- actually knew that their reported prices were not their ‘usual and customary’ prices when they reported those prices;
- were aware of a substantial risk that their higher, retail prices were not their ‘usual and customary’ prices and intentionally avoided learning whether their reports were accurate, or
- were aware of such a substantial and unjustifiable risk but submitted the claims anyway…
If petitioners can make that showing, then it does not matter whether some other, objectively reasonable interpretation of ‘usual and customary’ would point to respondents’ higher prices. For scienter, it is enough if respondents believed that their claims were not accurate.”
Proving that providers submitted false claims just got tougher for enforcers.
See Ms. Hogue’s earlier report on this SCOTUS case in our June 7 edition: homecaretechreport.com/article/3587
©2023 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.
©2023 by Rowan Consulting Associates, Inc., Colorado Springs, CO. All rights reserved. This article originally appeared in Home Care Technology: The Rowan Report. homecaretechreport.com One copy may be printed for personal use; further reproduction by permission only. editor@homecaretechreport.com
