Tag Archives: DOJ

Feds Bring Heat of Culture of Compliance Into Fight Against Opioid Epidemic

The other day we wrote about the importance of treatment programs hiring educated and trained (and preferably “certified”) compliance professionals into the ranks of management, in order to identify and address non-compliant activities and to make corrections.  While not mandatory, government regulators and prosecutors often look to the implementation of an effective compliance program as a mitigating factor when it comes to penalties and punishment for otherwise non-compliant behavior.

However, merely hiring anyone and naming them as “compliance officer” is both dangerous, and in the case of Rochester Drug Co-Operative Inc,. one such “compliance officer” has been criminally charged for sticking his head in the sand while ownership was distributing millions of doses of opioids to alleged pill mills.

Rochester Drug Co-Op acted as a middleman between laboratories and pharmacie and grew to be one of the nation’s largest drug distributors at the height of its opioid push, supplying 1,300 pharmacies in the northeastern U.S., according to the DOJ. The DOJ claims sales soared from 2012 to 2017 as the company took on pharmacy clients that other distributors refused to service.

Law360 is reporting that William Pietruszewski a “logistics specialist” at Rochester, who was only later “handed” the role of Compliance Officer with little direction and no training, has also been charged with conspiracy to distribute narcotics, conspiracy to defraud and failing to tell the Drug Enforcement Agency about suspicious pharmacy orders. He has agreed to plead guilty.

DOJ said Pietruszewski was managing the warehouse and tracking inventory at Rochester Drug Co-Op when he took on a second role as chief compliance officer. The document suggested compliance was established as an afterthought to profit.

“This historic investigation unveiled a criminal element of denial in RDC’s compliance practices and holds them accountable for their egregious noncompliance according to the law,” DEA special agent Ray Donovan said after the charges were unsealed.

Pietruszewski was charged alongside the company’s chief executive, the role historically liable for business failings. Prosecutors stressed Pietruszewski’s compliance position in public statements and weaved his “woefully inadequate due diligence program” throughout the charging documents filed last week.

“One of the lessons here, certainly, is that one of the first things the government is going to look at is the compliance program,” Tom Hill of Pillsbury Winthrop Shaw Pittman LLP said. “They want to see if it’s designed in an effective way and implemented with the appropriate degree of seriousness and rigor, as opposed to being there for window dressing purposes.”

The weight that prosecutors place on corporate compliance programs has only grown in the quarter-century since the DOJ established expectations for them in criminal sentencing guidelines. Pietruszewski’s case is a shining example, attorneys said, that compliance structure and effectiveness can determine the outcome of a government investigation.

“It continues to seep into the fabric of corporate America,” said Margaret Cassidy, chair of the American Bar Association’s compliance committee. “Even in smaller companies, they’re beginning to realize the vulnerability they have, the risk they have if they don’t develop some sort of ethics and compliance program.”

Experts said compliance programs should be designed to deal with situations like the one alleged at Rochester Drug, where CEO Laurence Doud and another executive — who remained unidentified and uncharged as of Tuesday — are said to have bred a culture of noncompliance.

“The question is if you have enough checks and balances so that, when mistakes happen, you are likely to catch them,” Hill said. He suggested, for starters, that companies must take every internal complaint seriously. Rochester Drug Co-Op failed on that front too, prosecutors claimed.

Read more at: https://www.law360.com/compliance/articles/1154054/with-opioid-charges-doj-signals-compliance-fixation?nl_pk=3926f25e-f017-4ab5-bd96-c6f73d2dab12&utm_source=newsletter&utm_medium=email&utm_campaign=compliance?copied=1

Feds Reconsidering Stark and Anti-Kickback Safe Harbors

The concepts of the federal Stark Law and its companion Anti-Kickback Statute (AKS) are often used interchangeably by health care industry providers, though both laws are different in applicability.

A chart detailing the differences has been prepared by HHS and can be found here: https://oig.hhs.gov/compliance/provider-compliance-training/files/starkandakscharthandout508.pdf
Health & Human Services (HHS) and its Office of Inspector General (OIG) HHS has been taking comments from industry as to ways to “update” the rules implementing the Stark Law and the AKS to meet modern evolutions in physician/employee compensation and other financial arrangements which industry believes are outdated and stifle innovation.

According to recent reporting by ModernHealthcare.com:

“Hospitals have urged HHS’ Office of Inspector General to recognize that payments between providers in the same alternative pay models do not violate federal anti-kickback laws, warning they may not participate in the programs otherwise. Alternative pay models can violate anti-kickback laws because they can include incentives and shared savings payment agreements to reduce the cost of care, which could influence a provider to use a certain vendor, refer patients to specific facilities or order more services that are paid for by federal healthcare programs. But providers told the OIG that the laws are too broad and they’re getting in the way of the move to value-based care. Some providers called on the agency to create a so-called safe harbor for payments made between hospitals, physician groups and skilled-nursing facilities in value-based arrangements to allow them to split shared savings payments.”

Relevant to the addiction treatment industry was commentary about forms of “payments” to patients.

“Providers also want to protect payments to patients to address their social determinants of health. These payments may violate anti-kickback statute because a beneficiary could feel obligated to continue receiving care from that provider.  But patients are more likely to lose weight if they have a financial incentive, according to American College of Cardiology President Dr. Michael Valentine. If physicians can pay for food, clothing or even transportation to and from healthcare visits, that could improve patient health. Valentine called for an expanded safe harbor that would allow physicians to pay patients to improve their social determinants of health.  Karen Ali, general counsel at the New Jersey Hospital Association, agreed that OIG should not penalize hospitals for these payments, as they could reduce unnecessary readmissions. ‘Hospital responsibility for patient care no longer begins and ends at the hospital door,’ Ali said. The comments are in response to a Request for Information issued by HHS’ OIG this past summer. The agency asked providers how it could encourage value-based pay arrangements. It received more than 350 responses. The CMS is also looking to soften anti-kickback regulations. It issued its own RFI to determine how it can minimize the regulatory barriers around the so-called Stark law.”

At the local (Florida) level, and now at the federal level with the adoption of the new “Eliminating Kickbacks in Recovery Act” (EKRA), the importance of updates to the AKS is relevant for two main reasons:

  1. Florida’s Patient Brokering Act (PBA), s. 817.505, Fla. Stat., holds out as “defenses” anything that is deemed a “safe harbor” within the federal AKS (meaning, if HHS/OIG says a certain action does not violate the AKS, then Florida law says it also does not violate the PBA); and
  2. EKRA, which passed at part of the SUPPORT Act of 2018, does specifically include certain “safe harbors” but also explicitly contemplates that DOJ and HHS will adopt rules to further clarify those exceptions.

As proposed rules relaxing the AKS are rolled out, we will certainly keep everyone updated.  However, we continue to strongly believe (if not know) that any such benefit given to a patient with the intent to induce patronage will continue to be disfavored as being against public policy.