Last week, on April 18, several federal agencies jointly launched a “one-stop shop” to facilitate reporting of allegedly anticompetitive behavior in the health care sector. While there has always been a complaint portal for the antitrust agencies, the Federal Trade Commission (FTC), the U.S. Department of Health and Human Services (HHS), and the Antitrust Division
Other OIG Developments
HHS OIG Invites Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors
On December 23, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its annual notice soliciting recommendations for new or modified, safe harbor provisions under the federal anti-kickback statute. The notice also invites suggestions for new OIG Special Fraud Alerts. The OIG will accept proposals until February…
Yates Memo Promises to be a Game-Changer for Health Care Executives
The Department of Justice’s “Yates Memo” sets forth regulatory principles, applicable to both civil and criminal investigations, to ensure that individuals are held accountable for corporate wrongdoing. While several U.S. Attorney Offices had been applying many of these principles already, the Yates Memo now establishes the principles expected to be followed by all U.S. Attorney…
Obama Administration Announces Record Medicare Strike Force “Takedown”
On June 18, 2015, HHS Secretary Sylvia M. Burwell and Attorney General Loretta E. Lynch announced that a nationwide Medicare Fraud Strike Force sweep resulted in health fraud charges against 243 individuals involving approximately $712 million in false billings – the largest number of defendants and dollar amount in Strike Force history. Charges in the…
OIG Report Assesses Accuracy of CMS Financial Assistance Payments to ACA QHP Issuers
According to a recent OIG report, CMS’s internal controls did not effectively ensure the accuracy of almost $2.8 billion in advance cost-sharing reduction (CSR) payments made to ACA qualified health plan (QHP) issuers during the period of January through April 2014. As a result, the OIG recommended that CMS take a series of steps to…
An Apple a Day Keeps the OIG Away: Practical Guidelines for Structuring Physician Compensation Arrangements to Avoid Kickback Allegations
On June 9, 2015, the Office of the Inspector General of the Department of Health and Human Services (OIG) released a fraud alert warning physicians to scrutinize carefully the conditions and terms of any medical director or other compensation arrangement they enter into with potential recipients of Federal health care program business. The risks associated with these arrangements under the anti-kickback statute are not new. However, the fraud alert signals the OIG’s current focus on physicians, which reportedly has also included hiring additional attorneys to handle investigative and enforcement activity involving physicians. Moreover, the government now has access to unprecedented amounts of data regarding financial arrangements between physicians and drug and device manufacturers.
The fraud alert follows on the heels of a dozen recent settlements between the OIG and individual physicians who allegedly received kickbacks disguised as medical directorships and other office staff arrangements. In those settlements, the OIG determined the physicians played an integral role in the schemes and specifically alleged that the agreements:Continue Reading An Apple a Day Keeps the OIG Away: Practical Guidelines for Structuring Physician Compensation Arrangements to Avoid Kickback Allegations
OIG Posts Spring Semiannual Report to Congress
The OIG’s latest Semiannual Report to Congress describes significant investigative and enforcement activities relating to HHS programs and operations during the first half of FY 2015 (October 1, 2014 – March 31, 2015). The OIG reports expected recoveries of more than $1.8 billion during this period, consisting of nearly $544.7 million in audit receivables and about…
OIG Releases FY 2015 Work Plan Mid-Year Update
The HHS OIG has updated its FY 2015 Work Plan to reflect new and/or completed items since release of its Work Plan in October 2014. Of note, the OIG has announced its plans to conduct several new Medicare reviews addressing: intensity-modulated radiation therapy; hospital preparedness and response to high-risk infectious diseases; access to DME in…
OIG Examines Medicaid/Part D Drug Rebate Policy
The OIG has issued a report, Medicaid Rebates for Brand-Name Drugs Exceeded Part D Rebates by a Substantial Margin,” comparing statutory Medicaid rebate amounts for brand name drugs with rebates Part D plan sponsors negotiate with drug manufacturers for such drugs. Based on 2012 data, the OIG determined that total rebates under Medicaid were…
OIG Flags Overpayments Due to Incorrect Physician Place-of-Service Coding
According to a recent OIG report, "Incorrect Place-of-Service Coding Resulted in Potential Medicare Overpayments Costing Millions,” physicians did not always correctly code the place of service on Part B claims. This resulted in potential overpayments of approximately $33.4 million for services provided from January 2010 through September 2012. The OIG explains that physicians performed…
OIG Reviews HHA Background Check Policies
In response to a Congressional request, the OIG has reviewed the extent to which home health agencies (HHAs) have employed individuals with criminal convictions and whether state requirements should have disqualified such individuals from HHA employment. The OIG points out that there are no federal requirements that HHAs conduct background checks on employees, and state…
OIG Early Alert on State-Based ACA Marketplace Funding Use
The OIG has issued an “Early Alert” warning regarding the use of federal funding by state-based marketplaces under the Affordable Care Act (ACA). The OIG notes that the ACA clearly prohibits marketplaces from using grant funds to support ongoing operations after January 1, 2015. The OIG expresses its “concerns that, without more detailed guidance from…
OIG Assesses FDA Progress on Oversight/Inspections of Generic Drug Manufacturers
In a recent report, the HHS OIG concludes that FDA has made progress in improving oversight of generic drug manufacturers, including greater parity in inspections of foreign and domestic generic drug manufacturers. A summary of the report, FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs, is available on our Life…
OIG Partners with Industry Associations by Issuing Practical Guidance for Health Care Governing Boards on Compliance Oversight
On April 20, 2015, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) released educational guidance designed to assist governing boards of health care organizations (“Boards”) in their compliance oversight functions. This guidance, entitled “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”), was developed in a collaborative effort among the OIG, the Association of Healthcare Internal Auditors (“AHIA”), the American Health Lawyers Association (“AHLA”), and the Health Care Compliance Association (“HCCA”). The Guidance updates previous guidance issued by OIG and AHLA, and incorporates insight from the AHIA and HCCA to help assist the internal auditors, compliance officers, and lawyers that report to the Boards. The document addresses four key issues relating to a Board’s oversight and review of compliance program functions: (1) the roles and relationships among an organization’s audit, compliance, and legal departments; (2) the mechanisms and processes for reporting to the Board; (3) identifying and auditing regulatory risk; and (4) methods to encourage organization-wide accountability for achieving compliance goals and objectives.
Continue Reading OIG Partners with Industry Associations by Issuing Practical Guidance for Health Care Governing Boards on Compliance Oversight
OIG Releases Medicaid Fraud Control Units Fiscal Year 2014 Annual Report
The OIG has released its Medicaid Fraud Control Units (MFCU) Fiscal Year 2014 Annual Report, which highlights statistical achievements of the 50 MFCUs nationwide, along with related OIG oversight activities. With regard to criminal cases, the report notes:
- MFCUs reported 1,318 criminal convictions, most frequently involving home health care aides, certified nursing aides, and other medical
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Health Care Fraud and Abuse Control (HCFAC) Program Reports $3.3 Billion in Recoveries
According to the FY 2014 HCFAC program report, more than $3.3 billion was recovered in FY 2014 as a result of the government’s health care fraud judgments and settlements, including $2.3 billion won or negotiated by the federal government in FY 2014. Since the HCFAC program began in 1997, it has returned more than…
OIG Issues 2015 Compendium of Unimplemented Recommendations
The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others:
- Payment Policies and Practices: Expand the DRG window to include additional days prior to
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OIG Posts FY 2014 State Medicaid Fraud Control Unit (MFCU) Data
The HHS Office of Inspector General (OIG) has released detailed statistical data on MFCU enforcement actions, recoveries, and expenditures for fiscal year 2014. Overall, state MFCUs reported more than $2 billion in criminal and civil recoveries (settlements, judgments, or prefiling settlements) in FY 2014, more than $1.7 billion of which were civil recoveries. The…
OIG Reviews Medicare Reimbursement for Critical Access Hospital (CAH) Swing-Bed Services
A recent OIG report examines increasing use of CAH “swing-bed” services, which the OIG describes as being equivalent to services performed at a SNF, but which are reimbursed at 101% of a CAH’s reasonable cost rather than at the Medicare SNF PPS rate. The OIG estimates that Medicare could have saved $4.1 billion over six…
OIG Repeats Calls for Expanded Medicare Part B Drug Price Substitution Policy
The OIG has issued the latest in a long line of reports comparing Medicare Part B drug average sales prices (ASP) and average manufacturer prices (AMP), this time with a focus on 2013 pricing. By way of background, CMS has statutory authority to lower Part B drug reimbursement when a drug’s ASP exceeds its…