Audits & Investigations

Last week the U.S. Department of Justice (DOJ) announced its largest settlement with a drug distributor – AmerisourceBergen (ABC) – in the combined amount of $885 million.

ABC, through its Pre-Filled Syringe Program, allegedly caused numerous false claims to be submitted to the federal healthcare programs (1) for unapproved new drugs; (2) for drugs

Many pharmacies and clinics run background checks on their employees to assure that individuals have not been excluded from any federal health care program. Most healthcare providers incorporate this procedure into their Policies & Procedures requiring to check the OIG’s List of Excluded Individuals/Entities, as well as state databases before any employment decision is made.

Walmart and Sam’s Club have agreed to pay $825,000 to resolve allegations that they have violated the False Claims Act by automatically refilling Medicaid prescriptions. The allegations came from the state of Minnesota, which – as many other states – does not allow automatic refill of Medicaid prescriptions without an explicit request from the beneficiary

Recently, there were several large federal and state crackdowns on Medicare and Medicaid billing practices involving PBMs brought by whistleblowers under the False Claims Act. The Act allows anyone to sue any individual or company that is defrauding the government and recover funds on the government’s behalf by filing a qui tam lawsuit. The lawsuit

Following an unfavorable decision by the Office of Inspection General’s (OIG) regarding a free drug program run by Caring Voice Coalition, Inc. (CVC), CVC publicly announced that it would stop providing free medications to financially needy Medicare beneficiaries. As a result, OIG decided to rescind its decision and announced that it will not pursue administrative

There are three most important federal anti-fraud healthcare laws that every provider should be familiar with:

  • False Claims Act (filing false claims),

  • Anti-Kickback Statute (offering/receiving remunerations for patient referrals, and providing free or discounted services), and

  • Physician Self-Referral Law (Stark law).

Government agencies have three vehicles to enforce these laws:

  • Exclusion Authorities,

  • Civil Monetary Penalties

The Department of Justice (DOJ) announced that in 2017 it recovered more than $3.7 billion stemming from the enforcement of the False Claims Act. The healthcare industry accounted for most of it ($2.4 billion).
The largest portion of recoveries from the healthcare industry came from drug and medical device companies (more than $900 million). The

Pharmacy practice:

  • New compounding rules: While USP 800 does not go into effect until July 2018, the California State Board of Pharmacy imposed its own requirements for the handling and compounding of hazardous drugs. It did not adopt USP 800 in its entirety and enacted some unique provisions, for example requiring that:

  • all CPEC be

While the opioid epidemic continues, every provider in the drug supply chain has a duty to identify and report suspicious orders. Retail pharmacies in particular have been hit with a number of settlements in 2017 for failure to report suspicious prescribing. See Related Blog. Surprisingly, many pharmacies still do not have policies and procedures addressing

On September 27, 2017, a subsidiary of AmerisourceBergen – AmerisourceBergen Specialty Group (ABSG) – admitted to illegally distributing misbranded drugs.  ABSG agreed to pay $260 million to resolve criminal liability for distribution of oncology supportive drugs from a facility that was not registered with the FDA. During the hearing, federal agents from various federal branches