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Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform

The good, reassuring news about that “old dog” fraud and abuse as it enters an age of payment reform is that criminal liability for fraud still requires a specific intent to defraud the federal health care programs, anti-kickback liability still requires actual knowledge of at least the wrongfulness, if not the illegality, of the financial transaction with a referral source, and civil False Claims Act liability for Stark Law violations still requires actual knowledge, a reckless disregard for, or deliberate ignorance of the Stark Law violation. This should mean that good faith and diligent efforts to comply with law, including seeking and following legal counsel, still go a long way in managing an organization’s and individual executive’s risk under the fraud and abuse laws. The bad, unsettling news about fraud and abuse in an age of payment reform, however, is that (1) anxiety about reform and stagnating and declining physician incomes are propelling a spike in transactions between health systems and physicians at a time when qui tam plaintiffs and the law firms that represent them are aggressively challenging the legitimacy and common structures for these transactions; and (2) the Stark Law is largely indifferent to the good faith intentions of health systems to integrate and enter into coordinated care arrangements with physicians, and continues to impose on health systems heavy burdens of proof that the arrangements comply with ambiguous standards like fair market value, volume or value and commercial reasonableness. While financial transactions incident to the Centers for Medicare and Medicaid Services’ (CMS) innovative care delivery and payment initiatives, such as accountable care organizations (ACOs), medical homes and bundled payment arrangements can be protected by the fraud and abuse/Stark waivers discussed in Part B below, there are many other common transactions and arrangements with physicians still operating in a fee-for-service environment  (such as practice acquisitions, employment, “gainsharing,” service line co-management, pay-for-quality and non-ACO clinically integrated networks) that are not protected by the waivers. During this period of transition to transformation of the health delivery and payment system, the key areas of risk for health systems are their burdens of proof on the ‘big three” issues of:

  • Fair market value,
  • Volume or value, and
  • Commercial reasonableness.

Each is discussed separately below, and the industry practices for managing these risks. Please note that none of these practices are necessarily “best” or “normative” practices, but are what we have observed.

Read the full article here.




OIG Expands Audit Topics in Work Plan Update

The Department of Health and Human Services Office of Inspector General (OIG) issued an update to its Work Plan on May 28 that included several new Medicare-related topics for OIG audit or inspection.  These additions expand OIG’s work in areas that OIG has previously identified as priorities, such as hospital-based services, lab testing and Part D payments.  These new topics included:

  • Hospital outpatient intensity-modulated radiation therapy claims;
  • Payments for clinical diagnostic laboratory tests, including the top 25 clinical diagnostic laboratory tests by Medicare expenditures in 2014. This report is required by the Protecting Access to Medicare Act; and
  • Compliance with various aspects of the inpatient rehabilitation facility prospective payment system, including the documentation required 42 CFR § 412.622(a)(3) (4) and (5).
  • Examining billing trends within the Part D program, especially those for opioid drugs and pharmacy billing patterns.

OIG also announced several new programmatic studies and reports, including:

  • Examining hospital preparedness for public health emergencies due to high-risk infectious diseases.
  • Identifying best practices and possible challenges in Accountable Care Organizations’ (ACO) use of electronic health records, such as interoperability issues.
  • Whether the durable medical equipment competitive bidding program is affecting beneficiary access to certain items, citing to “anecdotal reports [that] allege that competitive bidding has led to reduced access to DME and, in turn, compromised the quality of care beneficiaries receive” as the reason for adding this review.
  • Creating a portfolio report of the OIG’s Medicare Part D oversight work to summarize OIG audits, evaluations, legal opinions and investigative work, and provide progress information on recommendations to improve oversight of the program by the Centers for Medicare & Medicaid Services, plan sponsors and Medicare Drug Integrity Contractors or MEDICs. This report will likely be similar to the 2012 portfolio report highlighting OIG’s work on personal care services.
  • Examining CMS’s management of the Open Payments program, including CMS’ oversight of manufacturers’ and group purchasing organizations’ compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.



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