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Keeping you afloat admidst the rising sea of regulations

New OIG Drug Pricing and Reimbursement Portfolio Now Online

Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.

New Final Regulations Provide Overdue Guidance on Permissible Arrangements Between Providers, Financial Relief for Patients

Over two years after proposing rules for comment, the Office of Inspector General for the Department of Health and Human Services (OIG) just published a final rule which revises and adds new safe harbors to the Anti-Kickback Statute (AKS) and amends the definition of “remuneration” under the Civil Monetary Penalty (CMP) rules.

OIG 2017 Work Plan Lists New Enforcement Priorities

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for fiscal year 2017 (2017 Work Plan), which furnishes key guidance to providers and suppliers (collectively referred to here as “providers”) and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

Compliance Today Features Article by Arent Fox Health Care Attorneys on OIG’s Revised Exclusion Criteria

In the Compliance Today article, “OIG’s revised exclusion criteria: Reducing the risk,” Arent Fox Health Care partner and leader of the DC practice Linda Baumann and Health Care associates Samuel Cohen and Hillary Stemple discuss the updated criteria that the US Department of Health and Human Services Office of Inspector General (OIG) will consider when deciding whether to exercise its permissive exclusion authority.

OIG Means It When It Says It: Kindred Healthcare, Inc. Pays Record Penalty For Violating CIA

Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement (CIA.) The $3 million penalty is the largest issued for a violation of a CIA to date, and is a strong reminder from the Office of the Inspector General (OIG) to the industry that CIAs are not to be ignored. 

Is the Discount Safe Harbor No Longer “Safe?”

In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment in United States ex rel. Banigan v. Organon USA, Inc., et al.

CMS’s Long-Awaited Final 60-Day Repayment Rule Provides Guidance and Eases Some Requirements for Health Care Providers and Suppliers

On Friday, February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited Final Rule and regulations,[1] providing much needed guidance to providers and suppliers on how to meet the Affordable Care Act’s (ACA’s) 60-day overpayment mandate.[2] Specifically, a provision enacted as part of the ACA in 2010 requires that all Medicare and Medicaid overpayments be reported and returned by the later of (i) 60 days after the date on which the overp

OIG Reminds Providers that the Donation of EHR Systems with Limited Interoperability May Violate the Federal Anti-Kickback Statute

On October 6, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an OIG Alert reminding the public that electronic health records (EHRs) furnished to referral sources may not meet the federal anti-kickback statute’s EHR safe harbor if the EHR system has limited or restricted interoperability.

Covered Entities and Business Associates Beware! New HIPAA Audits to Begin in Early 2016

Health care providers and their contractors have been put on notice by the Office for Civil Rights (OCR) that the next round of HIPAA compliance audits will begin in early 2016.  The previous round of HIPAA audits was completed in 2014.  While OCR previously had signaled that the HIPAA audits would be resuming in the near future (such as by noting the upcoming release of a new audit protocol), OCR’s new statement is the most definitive information curr