Categories
Innovation in Compliance

Not Your Father’s Monitor-Part 4: Jesse Caplan on the Intersection of Antitrust and Healthcare Monitors


In October, Deputy Attorney General (DAG) Lisa O. Monaco gave a Keynote Address at ABA’s 36th National Institute on White Collar Crime (Monaco Speech). Monaco’s remarks should be studied by every compliance professional as they portend a very large change in the way the DOJ will utilize monitors going forward. Over this podcast series, sponsored by AMI we will consider why DAG Monaco’s remarks herald a new era for monitorships.
Over this podcast series we have considered Monaco’s remarks from a variety of perspectives. Bethany Hengsbach considered this change in monitorships from the white-collar enforcement and defense perspective. Mikhail Reider Gordon looked at global aspects of the new DOJ monitor’s focus. Cristina Revelo discussed how E&C assessments help drive more compliant companies. Vin DiCianni looks at where monitors and monitorships are going in 2022 and beyond. In this Episode 4, Jesse Caplan brought his views on the intersection of the twin topics of antitrust and healthcare compliance.
Highlights of this podcast include

  1. What is the intersection of healthcare and antitrust compliance?
  2. Why compliance and ethical culture have become so important from a regulatory perspective, a commercial perspective and a talent acquisition and maintenance perspective?
  3. How and why are States’ Attorney Generals using monitorships with greater frequency and focus.

Resources
Jesse Caplan
Affiliated Monitors Inc.

Categories
Blog

Not Your Father’s Monitor – Jesse Caplan on Antitrust and Healthcare Compliance

In October, Deputy Attorney General (DAG) Lisa O. Monaco gave a Keynote Address at ABA’s 36th National Institute on White Collar Crime (Monaco Speech). Her remarks reframed a discussion about the uses of, reasons for and perceptions on independent monitors and monitorships. I asked Affiliated Monitors Inc. (AMI) founder Vin DiCianni for his thoughts around the remarks on monitors. He said, “For Affiliated Monitors this refreshed approach by DAG Monaco highlights the seriousness which businesses must place on the investment in their programs and in addressing what has for some been a negative experience with a monitor. For those who might be the subject of a monitorship, DAG Monaco recognized that the negativity that has sometimes surrounded monitorships as being punitive, should be seen in a different light bringing value, pointing a way forward and as a solution which has had great success in resolving matters.”
Monaco’s remarks should be studied by every compliance professional as they portend a very large change in the way the Department of Justice (DOJ) will utilize monitors going forward. Over this podcast series, sponsored by AMI, we will consider why DAG Monaco’s remarks herald a new era for monitorships. We will consider Monaco’s remarks from a variety of perspectives. Bethany Hengsbach discussed this change in monitorships from the white-collar enforcement and defense perspective. Mikhail Reider-Gordon looked at global aspects of the new DOJ monitor’s focus. Cristina Revelo discussed how ethics and compliance (E&C) assessments help drive more compliant companies. We will conclude the series with Vin DiCianni who will look at where monitorships are going in 2022 and beyond. In Part 4, Jesse Caplan, Managing Director of Corporate Oversight, brings his views on the twin topics of antitrust and healthcare compliance.
Both antitrust and healthcare have significant needs for monitorships. Antitrust concerns raised by the government can be handled through a monitorship of specific issues so that a merger can often go through and satisfy the regulators. This is a prime example of the DOJ or Federal Trade Commission (FTC) extending their reach so that anti-competitive issues do not arise or are properly remediated. Healthcare regulators are most interested in the continued delivery of healthcare services, particularly on the state and local level. It is not in anyone’s interest to stop the delivery of healthcare services which puts a hospital, healthcare practice group or doctor out of business, absent grievous circumstances. By using a monitor, a state regulator can help assure an appropriate level of compliance from a healthcare provider.
There were three key components from the Monaco Speech around monitors. Number one, that monitors are not viewed by the DOJ as punitive and should not be viewed as such by the compliance community or wider corporate community. Here Caplan observed, it is not the job of a monitor “to be punitive, but rather to facilitate a successful compliance program and a successful settlement agreement, works with both the government and for the company.” Number two is a monitor can act as an early tripwire to prevent companies from sliding into a recidivous situation. Number three, monitors bring a level of skill and talent around compliance programs and corporate culture that can help companies create a best practices program so the monitor actually works with the companies under an enforcement action to help them create a program that will be sustainable far down the road. Caplan said, a monitor can bring an “appreciation for what government enforcers are looking for, what the goals of government regulators are, as well as some of the challenges and goals of companies, who want to be successful and to do so in a compliant and fair manner.”
We then turned to the evolution of thinking of state regulators around monitors. Caplan noted, “some of these state Attorney General’s (AG) offices have realized for a long-time monitors can really be a resource extend for government agencies and particularly enforcement agencies.” He pointed to the example of the “Massachusetts Attorney General’s office, particularly with their Medicaid fraud control.” He went on to say, “more and more state AGs are using monitors when they enter in settlement agreement with conditions.” Using an independent allows an extension of their resources, to “verify that the company is compliant with those settlement conditions.”
Perhaps most powerfully, independent monitors can be seen as “an honest broker, bridging between the company and the regulator. Moreover, monitors can actually facilitate, a successful transition and then termination of a monitorship.” Caplan said, “we can do that because we can have candid conversations with both the company and then separately with the government, so that we can better understand where there might be disconnect between the two, and then we can help connect compliance up so that there’s not misunderstandings. There may be different expectations that end up sometimes torpedoing a settlement agreement and by having those conversations, by serving as that bridge, we can help prevent problems address so that ultimately the monitorship is successful.”
Affiliated Monitors
Jesse Caplan

Categories
Integrity Through Compliance

From Business Opportunities to Compliance Risks: Healthcare Expectations in 2021

 
 

In this weeks installment, Jesse CaplanDionne Lomax, and Jim Anliot team up to discuss wide ranging risks and opportunities for healthcare practitioners and entrepreneurs. Dionne Lomax reflects on the unprecedented collaboration that was necessary to provide quality care in the height of the COVID-19 crisis. But antitrust and fraud concerns come with the territory, and the panel provides anecdotes and advice for dealing with this collaboration. Additionally, Jim Anliot’s main advice for anyone looking to innovate in the healthcare space with a new idea or service needs the guidance of experts to navigate the extremely complicated regulatory landscape.
 

 
Email podcast@affiliatedmonitors.com with comments or questions, and be sure to subscribe and/or leave a review if you enjoy this show!
 

Categories
Sunday Book Review

Sunday Book Review: May 23, 2021, the Summer Non-Fiction edition


In today’s edition of Sunday Book Review:

Categories
The Ethics Experts

Episode 040–Karen Pendergraft


On this episode of The Ethics Experts, Nick welcomes Karen Pendergraft to discuss compliance in US and global healthcare clinical trials.

Check out more episodes, and don’t forget to subscribe on your favorite podcast platform!

Categories
The Affiliated Monitors Expert Podcast

3rd-party independents in the health care industry


In this episode, I am joined by AMI Managing Director Stern. We consider how defense counsel can work proactively with independent monitors to help clients who may have sustained an ethical or compliance violation or are under government scrutiny for allegations of illegal misconduct in a wide variety of industries, disciplines and corporate settings. We look at a third-party independent in the health care industry.
In many ways the health care arena can be similar to other business, with their need to work with third-party independents. Stern said, “the cost of getting it wrong these days is very high. It’s not just the cost of hiring lawyers to defend you with a government agency or the Department of Justice. It is even more than the reputational risk. If you are a public company, your stock price is probably going to take a nosedive.” This makes bringing in a third-party independent a “cost effective step to try to get ahead of the situation.” All of this means that bringing in a third-party independent, on a proactive basis to assess a compliance program to bring it up to a best in class standard can really work as a business advantage. Stern believes that to be correct and added, “we work with the company at benchmarking and coming up with best practices. I think most companies want a kind of a state of the art,  best practice compliance program rather than simply rely upon what worked five years or 10 years ago.”
Find out more about Affiliated Monitors Inc. by checking out their website here.

Categories
FCPA Compliance Report

The Current State of Compliance – Issues and Challenges: Part 5 – New Compliance Concerns in Healthcare

Over this five-part podcast series, I have visited with Terry L Orr, a Managing Director at Kroll, a division of Duff & Phelps, and the sponsor of this podcast series. We have taken a comprehensive look at state of compliance at the half-year mark of 2019. In the concluding episode, Part V, we consider some of the latest challenges for healthcare compliance, including legislative changes and a recent corruption trial which Orr believes will be seen as a landmark event.
There are some safe harbor exceptions but outside of those exceptions a broad interpretation of value is used. For more information on Kroll, a division of Duff & Phelps, click here. For more information on Terry Orr, click here.

Categories
FCPA Compliance Report

Emerging Issues in Healthcare Compliance and Monitoring-Episode 1–Focus on Opioid Prescribing – Regulatory and Liability Risks

In this special five-part podcast series, sponsored by Affiliated Monitors, Inc., I visit with AMI Managing Director Jesse Caplan on emerging issues in healthcare compliance and monitoring. Healthcare provider organizations and practices face many different types of potential regulatory and liability risks – in this first episode we focus on the risks posed by opioid prescribing. We consider the some of the following issues: 

What are the risks to providers and health care organizations from opioid prescribing? 

  1. Policymakers and the healthcare industry are trying to address the opioid crisis in a number of different ways. One of those ways is to focus on the prescribing of opioids, with the goal of significantly reducing the number of people who are prescribed opioids and become addicted or who divert legally prescribed drugs. 
  2. Health care providers who engage in inappropriate opioid prescribing are increasingly subject to discipline by professional medical boards. They face restrictions on their licenses to practice, and in certain cases, have had their licenses suspended or revoked. 
  3. Where patients are harmed, providers face civil medical malpractice liability.
  4. And in the most egregious cases, providers have been prosecuted criminally, either under the federal Controlled Substances Act or state criminal laws. 

What has been the response of the Department of Justice? 

  1. The Department of Justice (DOJ), both in Washington and in individual United States Attorney’s Offices, have become more aggressive at identifying providers with problematic or suspicious opioid prescribing records.
  2. For example, in 2017, then Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit.In his announcement the Attorney General stated DOJ would use data analytics to identify physicians who are writing opioid prescriptions at a rate that exceeds other physicians, and how many of a doctor’s patients died within 60-days of an opioid prescription.
  3. In 2018, US Attorneys in Massachusetts and Georgia sent warning letters to physicians who had relatively high opioid prescribing histories, or physicians who may have had a patient die from an overdose, or who died for any reason within two-months of being prescribed opioids.
  4. In the letters in Massachusetts, the US Attorney reminded the physicians that prescribing opioids without a legitimate medical purpose or in excessive amounts is illegal. Of course, this begs the question:  for physicians who genuinely care about their patients and are trying to treat real chronic pain, how do they ensure they are prescribing for a legitimate medical purpose or diagnosis where opioid treatment is both indicated and appropriate?  What dosages or number of pills is “an excessive amount” that could put the physician at legal jeopardy?  

What are legislators and regulators doing to address the opioid crisis? 

  1. The crisis has resulted in new laws and regulations addressing hospital staffing, their discharge and treatment processes, limits on the quantity and dosages of opioids that can be prescribed, and mandated use of state Prescription Drug Monitoring Program databases (PDMPs).   
  2. Just this February, CMS issued a letter to all Medicare providers with what they call their “roadmap”, focusing on “preventing new cases of opioid-ise disorder,” “treating patients with opioid use disorders,” and “using data to target prevention and treatment activities.” 
  3. As a result of this evolving legal environment, individual physicians and physician extenders, group practices, hospitals, and even insurance companies who are increasingly employing physicians, face significant regulatory and liability risks if they are engaging in inappropriate and dangerous opioid prescribing practices, or not complying with the increasingly complex prescribing laws and regulations. 

What is the legal and regulatory framework impacting opioid prescribing?

  1. There are a number of federal and state laws impacting opioid prescribing practices. Some of the more recent and significant developments include state laws limiting the quantity and dosage of opioids that can be prescribed and requiring providers to use and check PDMP databases before prescribing certain drugs to a patient.  There are also more sophisticated guidelines for practitioners, including CDC Guidelines, for prescribing opioids, which are becoming the standard of care for prescribers. 
  2. For example, just about every state has a PDMP, which is a database that tracks a patient’s history of opioid prescriptions.Increasingly, states require providers to check the PDMP before prescribing opioids.  By checking the PDMP the physician can be informed whether the patient appears to have an addiction problem, may be doctor-shopping for opioid prescriptions, may be diverting drugs, or might be at risk for dangerous drug interactions. 
  3. More and more states are passing laws limiting the quantity or dosage of opioids prescribed. For example, Massachusetts, the first state to pass such a law in 2016, set a seven-day limit on initial opioid prescriptions. 
  4. The CDC’s Guidelines are targeted to primary care physicians treating adult patients for chronic pain and are designed to improve communications between providers and patients about the benefits and risks of using opioids, and ultimately to reduce opioid addiction and overdoses.  According to the CDC, the three main principles behind the Guidelines are:
  5. Non-opioid therapy is preferred for chronic pain in most circumstances;
  6. The lowest possible effective dosage should be prescribed; and
  7. Clinicians should always exercise caution when prescribing opioids and should closely monitor their patients who have been prescribed opioids.
  8. The CDC then offers 12 separate recommendations addressing each of these principles.

What should be the primary compliance concerns for healthcare organizations in connection with the opioid crisis?

  1. The big questions for healthcare organizations are:
  2. Do you have policies and procedures in place to ensure that your staff, and particularly your physicians, are aware of all the new requirements for opioid prescribing?
  3. Have your providers and staff been educated in those policies and procedures?
  4. And are they actually following appropriate opioid prescribing practices, and all relevant laws and regulations, including the organization’s own prescribing polices? 

Join us for Episode 2, where we discuss how healthcare organizations can identify and mitigate the risks from opioid prescribing.
For more information on Affiliated Monitors, check out their website here.