Audits & Investigations

 In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that

The FDA has issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for tampering with opioid medications.

The FDA said the distributor didn’t address several instances of reported drug tampering for medications including opioids and treatments for HIV, seizures, bipolar disorder and high blood pressure.

The warning letter

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