Recent Publications - Geoffrey R. Kaiser


Deadline Fast-Approaching for Medicaid Managed Care Participating Providers
November 7, 2017 | Geoffrey R. Kaiser | Ashley S. Osadon | Health Services | Compliance Investigations & White Collar
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 …
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OIG Audit Discovers $51.6 M in Overpayments to Acute-Care Hospitals
October 17, 2017 | Geoffrey R. Kaiser | Jonathan D. Salm | Health Services | Compliance Investigations & White Collar
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 …
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Hidden Risks In Practice Acquisitions And Joint Ventures
May 25, 2017 | Complex Torts & Product Liability | Health Services
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 …
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OIG Releases Compliance Program Update
April 18, 2017 | Compliance Investigations & White Collar | Health Services
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 …
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OIG Rejects Laboratory’s Offer to Provide Free Labeling to Dialysis Facilities
March 10, 2017 | Health Services
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 …
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OIG Adds New Safe Harbor Protections in 2017
January 24, 2017 | Health Services
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 …
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Five Essential Questions To Mitigate Corporate Compliance Risk
November 18, 2016 | Compliance Investigations & White Collar | Health Services
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 …
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Safe Harbor, Safe Passage Under the Anti-Kickback Statute
November 11, 2016 | Health Services
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 …
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Kaiser Publishes Article in Corporate Compliance Insights
August 22, 2016 | Geoffrey R. Kaiser | Compliance Investigations & White Collar | Health Services
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 …
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Health Care Compliance: Tips For A Corporate Body Self-Exam
July 14, 2016 | Health Services | Compliance Investigations & White Collar
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 …
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Kaiser publishes article entitled, “Prosecutorial Discretion” in Nutrition Business Journal
March 7, 2016 | Geoffrey R. Kaiser | Compliance Investigations & White Collar | Health Services
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 …
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Hospital “Medical Necessity” Settlements: An Abuse of the False Claims Act?
November 23, 2015
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 …
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The Park Doctrine and the Perils of “Off-Label” Promotion
September 30, 2015
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 …
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DOJ Policy Memo Urges Prosecutors to Hold Individuals Accountable for Corporate Misdeeds
September 17, 2015 | Health Services | Compliance Investigations & White Collar
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 …
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Potential Changes to the Stark Exceptions in New CMS Proposed Rule
July 31, 2015
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 …
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Health Services Alert
July 24, 2015
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 …
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New Payment Models Bring New Healthcare Data Measurement Requirements
June 30, 2015
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 …
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OIG 2015 Work Plan Released
December 3, 2014 | Health Services
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 …
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Measuring Compliance Risk in Health Care Transactions
February 10, 2014 | Health Services
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 …
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Measuring Compliance Risk in Health Care Transactions
November 30, 2013 | Health Services
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 …
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Fool’s Gold: How To Avoid Suspect Business Arrangements in Diagnostic Testing Ventures
November 30, 2013 | Health Services
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 …
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All That Glitters Is Not Gold: The Importance of Compliance Due Diligence In Assessing Healthcare Transaction Value
September 30, 2013 | Health Services
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 …
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What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?
February 13, 2013 | Health Services
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 …
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Due Diligence On Execs, Board Vital When Sizing Up Companies
December 12, 2012 | Health Services
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
September 30, 2012 | Health Services
Please click the link below to view Risky Business: Rx Drugs Obtained in the Secondary Market. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Risky Business: Rx Drugs Obtained in the Secondary Market …
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Combating Online Counterfeiting with Help from the Lanham Act
November 30, 2011 | Health Services
Please click the link below to view Combating Online Counterfeiting with Help from the Lanham Act. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Combating Online Counterfeiting with Help from the Lanham Act …
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Ensuring Product Integrity and Trust in Your Supply Chain
October 5, 2011 | Health Services
Please click the link below to view Ensuring Product Integrity and Trust in Your Supply Chain. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Ensuring Product Integrity and Trust in Your Supply Chain …
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Billing For Drug Overfill: New Compliance Risk or Old Prohibition?
September 30, 2011 | Health Services
Please click the link below to view Billing for Drug Overfill: New Compliance Risk or Old Prohibition? Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Billing for Drug Overfill: New Compliance Risk or Old Prohibition? …
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When the Government Knows Too Much for its Own Good
September 9, 2011 | Health Services
Please click the link below to view When the Government Knows Too Much for its Own Good. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. When the Government Knows Too Much for its Own Good …
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Corporate Piracy Efforts: Cost Center or Profit Center
August 17, 2010 | Health Services
Please click the link below to view Corporate Piracy Efforts: Cost Center or Profit Center? Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Corporate Piracy Efforts: Cost Center or Profit Center? …
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Health Care Compliance on a Shoestring
June 10, 2010 | Health Services
Please click the link below to view Health Care Compliance on a Shoestring. Adobe Reader is required to view the bulletin. If Adobe Reader is not installed on your PC, click here to download and install. Health Care Compliance on a Shoestring …
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