Jeff Kaiser’s article, “DOJ Issues New Guidance on Criminal Enforcement,” appeared in the winter 2023 issue of USLAW Magazine.

Click here to read the article.

On September 15, Deputy Attorney General (“DAG”) Lisa Monaco delivered remarks announcing updated guidance on how the Department of Justice will be prioritizing and prosecuting corporate crime.  Her remarks were accompanied by a formal memo, titled “Further Revisions to Corporate Criminal Enforcement Policies Following Discussions with Corporate Crime Advisory Group” (https://www.justice.gov/opa/speech/file/1535301/download).  However inelegant the title,

As a candidate running for the office he now holds, President Biden advocated decriminalizing the use of marijuana, automatically expunging all prior marijuana use convictions, legalizing marijuana for medical purposes and rescheduling marijuana from Schedule I to Schedule II in order to permit scientific research into its effects, while leaving decisions regarding legalization of marijuana for

The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective

False Claims Act, Medical Necessity and Government Regulation of Medicine

In recent years, much attention has been paid to what makes a claim “false” under the False Claims Act (“FCA”) when the underlying misconduct is based on the alleged lack of medical necessity for the services provided.  Bearing on this issue are Court of Appeals

When the President has declared a national emergency under authorizing legislation, the Secretary of the U.S. Department of Health and Human Services is authorized to grant waivers to certain prohibitions under the Social Security Act, which includes the Stark Law, during a declared public health emergency in order to ensure (i) sufficient health care items

Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by the Senate on March 25 relate to laboratory diagnostic testing for the COVID-19 virus.

Within Division A of the CARES Act, titled “Keeping Workers Paid and Employed, Health Care System Enhancements, and Economic Stabilization,” there are four sections

The United States recently agreed to a $260 million settlement of criminal charges and related civil claims under the False Claims Act arising from a scheme to defraud conducted by Naples, Florida-based hospital chain Health Management Associates, LLC (HMA). The Department of Justice (DOJ) announced the settlement on September 25.

The settlement is evidence of

In a recent advisory opinion, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) concluded that a proposed donation of telehealth equipment to a referral source presented a low risk of fraud and abuse under the federal Anti-Kickback Statute. The conclusion was premised on several factors, one of which included OIG’s

The utilization of telehealth has flourished over the last decade as innovative technologies and new Medicare regulations have fueled telehealth’s growth. Between 2001 and 2015, Medicare telehealth spending increased by nearly 300% as a result of this boom. However, as the utilization of telehealth services has surged, so have the compliance issues associated with these

A recent report issued by the U.S. Department of Health and Human Services, Office of Inspector General (OIG), estimates that 61% of claims submitted to Medicare for outpatient physical therapy (PT) services failed to comply with Medicare requirements. The OIG report serves as a reminder to PT providers about the importance of accurate billing and

Geoffrey R. Kaiser’s article, “Government Dismissal under the False Claims Act: Policy Change or Much Ado About Nothing?” was published in Westlaw Journal White Collar Crime in the March 2018 issue.

Click here to read the article.

The federal Anti-Kickback Statute contains a statutory exception or “safe harbor” providing that the AKS will not apply to “any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services.” 42 U.S.C. 1320a-7b(b)(3)(B) (emphasis added). Similarly, the parallel regulatory exception states

On February 9, 2018, Congress passed the Bipartisan Budget Act of 2018, providing a two-year budget agreement that increases federal spending, funds disaster relief efforts, and amends a number of healthcare programs, among a host of other changes.

While the Act has broad implications for many aspects of U.S. law, one amendment in particular should

The deadline for required enrollment with Medicaid under the Federal 21st Century Cures Act (Cures Act) is fast approaching. Currently, Medicaid Managed Care providers are sending mass mailings to their participating providers with notices of required compliance.

By December 1, 2017 certain participating healthcare providers of New York State Medicaid Managed Care plans or the

The Office of the Inspector General of the Department of Health and Human Services (OIG) issued a report last month regarding inappropriate payments made to acute-care hospitals for outpatient services provided to Medicare beneficiaries who were inpatients of other facilities. OIG’s findings highlight the need to diligently review claims before submitting them to Medicare.

In

There is a potential compliance “blind spot” associated with what many in the healthcare industry would regard as ordinary practice acquisitions and joint ventures involving hospitals and other provider organizations. This area of possible vulnerability arises from the payment of consideration for what are sometimes insufficiently delineated assets of the target or partner entity. If

On March 27, 2017, the U.S. Office of Inspector General (“OIG”) released a new compliance program guide, Measuring Compliance Program Effectiveness—A Resource Guide (the “Guide”). The Guide was developed by compliance professionals and staff from the U.S. Department of Health and Human Services and OIG, as an effort to help healthcare organizations measure the effectiveness

The U.S. Office of the Inspector General (“OIG”) recently issued Advisory Opinion No. 16-12 (the “Opinion”) regarding a proposed arrangement between a laboratory and a dialysis facility. Briefly stated, the laboratory proposed to offer the dialysis facility free labeling of test tubes and specimen collection containers, a task which is typically performed by the dialysis

In December 2016, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services amended existing safe harbors and issued a number of new safe harbors to   protect certain business practices and arrangements of doctors, hospitals, and pharmacies from sanctions under the anti-kickback statute (42 U.S.C. § 1320a-7b(b)). Additionally, OIG amended

In an increasingly intense and unforgiving regulatory environment, all healthcare organizations — from small physician practice groups to large health systems — must closely scrutinize areas where they may be vulnerable to fraud and abuse allegations. Corporate compliance programs are useful in this effort, but only if they are well-constructed and aggressively implemented, not merely

For providers contemplating a business arrangement with a potential referral source for items or services reimbursable under a federal health care program, fitting that arrangement within a recognized safe harbor under the Anti-Kickback Statute (“AKS”) is the “holy grail,” for it ensures that the arrangement will be immunized against civil and criminal enforcement actions.  And

Geoffrey Kaiser has published an article entitled, “False Claims Violations in a Post-Escobar World,” in the August 15, 2016 issue of Corporate Compliance Insights.

Click Here to read the complete article.

© Copyright 2016 Corporate Compliance Insights. All rights reserved.

Geoffrey Kaiser has published an article entitled, “False Claims Violations in a Post-Escobar World,” in

Given the proliferation of health care regulations and white-hot spotlight of government enforcement efforts, it is becoming increasingly important for all health care organizations, ranging from small physician practice groups to large regional or national health systems, to attain a heightened level of self­awareness concerning areas in which they could be vulnerable to allegations of

Geoffrey Kaiser published an article in the Nutrition Business Journal entitled, “Prosecutorial Discretion.”  The article discusses the exercise of prosecutorial discretion under the Food, Drug & Cosmetic Act.  It analyzes the factors that enter into a decision by prosecutors to recommend criminal charges, using the recent indictment of USPlabs to illustrate the types of aggravating circumstances

Reports have surfaced that the federal government is preparing to announce settlements under the False Claims Act with hundreds of hospitals as part of a nationwide enforcement initiative into the suspected overuse of implantable cardiac devices, referred to as Implantable Cardioverter Defibrillators (“ICDs”).[1]  There reportedly are more than 500 hospitals under investigation, many if not

The regulatory landscape on which pharmaceutical and medical device companies tread daily is littered with compliance landmines, none more dangerous than US Food and Drug Administration’s (FDA) enforcement of the misbranding provisions of the Food, Drug & Cosmetic Act (FDCA).  It is not so much the fact of FDA’s enforcement – after all, one can

A policy memo issued on September 9, 2015 from Deputy Attorney General Sally Quillian Yates of the Department of Justice (DOJ) outlines a strategy for holding individuals in both civil and criminal enforcement actions accountable for misconduct by corporations and other business entities.  The memo was the product of a working group of senior DOJ

The Centers for Medicare and Medicaid Services (“CMS”) published its Calendar Year 2016 Physician Fee Schedule Proposed Rule (80 FR 41685 et seq.) which, in addition to updating the fee schedule, contains: (1) a proposed new quality measure that an Accountable Care Organization (“ACO”) must meet to qualify for shared savings in the Medicare Shared

Last month, the New York State Attorney General (“AG”) reached a settlement with Aspen Dental Management, Inc. (“ADMI”) after an investigation revealed that ADMI violated New York laws prohibiting the unauthorized practice of dentistry and dental hygiene, fee splitting and deceptive trade practices.  ADMI’s story is a cautionary tale to which investors and management companies

The BDO Center for Healthcare Excellence & Innovation and Rivkin Radler explore the rise of quality data as a reimbursement benchmark in this three-part series. Future newsletters will delve into the implications for measurement strategies and compliance.

Quality data is moving to the forefront of healthcare as a critical element of value and will serve

The Department of Health and Human Services, Office of the Inspector General (OIG) has released its Work Plan (Plan) for Fiscal Year (FY) 2015.  The annually published Plan summarizes new and ongoing compliance activities, audits, and enforcement priorities that OIG plans to pursue this upcoming year. 

The OIG identified two new initiatives related to hospital

Health care compliance attorneys are frequently asked to “rate” the risks around various existing or proposed business arrangements involving medical professionals.  Could a given arrangement be viewed as a violation of the Stark Self-Referral Law (“Stark”) or Anti-Kickback Statute (“AKS”)?  Are there compelling, or at least plausible, arguments for why the arrangement should instead be

The lure of easy money can draw some radiologists to engage in conduct reflecting what is, at best, an alarming lack of awareness and, at worst, a deliberate disregard of the serious criminalliability1 risks entailed in entering into certain suspect business arrangements  with diagnostic testing ventures. Radiologists must understand these liability risks in order to

Health care compliance attorneys are frequently asked to “rate” the risks around various existing or proposed business arrangements involving medical professionals.  Could a given arrangement be viewed as a violation of the Stark Self-Referral Law (“Stark”) or Anti-Kickback Statute (“AKS”)?  Are there compelling, or at least plausible, arguments for why the arrangement should instead be

The healthcare industry is undergoing rapid consolidation in response to an array of economic drivers.[1]  Medicare and Medicaid reimbursement cuts have resulted in downward pressure on revenues.  Meanwhile, other industry trends flowing from recent healthcare legislation like the Patient Protection and Affordable Care Act (“PPACA”) call for increased expenditures on expensive electronic health record information

Geoffrey (Jeff) Kaiser is a frequent speaker on the subject of off-label marketing and has published an article on the Second Circuit’s decision in United States v. Caronia, of which Jeff has a unique insider’s perspective, having handled the government’s investigation as Chief of Health Care Fraud Prosecutions in the United States Attorney’s Office for

Please click the link below to view Due Diligence On Execs, Board Vital When Sizing Up Companies. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install.

Due Diligence On Execs, Board Vital When Sizing Up Companies

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Risky Business: Rx Drugs Obtained in the Secondary Market

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Combating Online Counterfeiting with Help from the Lanham Act

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Ensuring Product Integrity and Trust in Your Supply Chain

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Billing for Drug Overfill: New Compliance Risk or Old Prohibition?

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When the Government Knows Too Much for its Own Good

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Corporate Piracy Efforts: Cost Center or Profit Center?

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Health Care Compliance on a Shoestring