The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the Federal anti-kickback statute (AKS), questions related to the civil monetary penalty (CMP) provision prohibiting remuneration to Medicare and State health care program beneficiaries, and questions relating to OIG’s enforcement authority under these statutes. OIG has stated it will respond to inquiries in the FAQ asking for general applications of AKS to a given type of arrangement. OIG also said it would answer questions regarding compliance and its healthcare fraud self-disclosure protocol.

A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and manipulation of Average Wholesale Pricing (AWP) rules. The complaint was filed by a pharmacist (the Relator) who previously worked for the defendant, Professional Compounding Centers of America Inc. (PCCA), a pharmaceutical supplier which sells active ingredients to compounding pharmacies. The Relator alleged that PCCA reported inflated AWPs for the ingredients it sold to its compounding pharmacy customers as part of a scheme that violated the FCA and AKS. The Government filed its complaint in partial intervention in November 2021, asserting FCA claims against PCCA for causing the submission of false claims to TRICARE and for reporting false AWPs to the pricing compendia upon which TRICARE reimbursement is based.

In recent months, retailers have faced increased pressure from litigation related to their sales practices. While there is overlap, sales practices litigation can fall into four different buckets: pricing, data collection, auto-renewal, and “free” lawsuits. This post focuses on trends in recently filed pricing litigation.

Audax Private Equity has announced it has completed a growth investment in Pyramid Laboratories.

Pyramid, based in Costa Mesa, Calif., is a drug product contract development and manufacturing organization. Founded in 1988, the company provides formulation development, analytical and stability testing, and aseptic fill-finish manufacturing services focused on large molecule therapeutics.

Audax, with

Hughes & Co. has completed an investment in Voluware, according to a news release.

Voluware, based in Huntington Beach, Calif., is a provider of cloud-based workflow and automation solutions for administrative healthcare transactions. Founded in 2011, its VALER platform is designed to help complete prior authorizations, eligibility verification and referrals document management.

Hughes

BPOC has announced it has established a new continuation fund with $425 million.

The continuation fund consists of healthcare services companies previously held by BPOC Fund IV. The transaction was co-led by investment funds affiliated with Apollo S3, Blackstone Strategic Partners and Five Arrows. 

BPOC, based in Chicago, seeks control and minority equity

CNL Strategic Capital has announced it has acquired a majority equity stake in TacMed Solutions.

TacMed, based in Anderson, S.C., designs, develops and manufactures medical products that equip, train and protect professionals in pre-hospital, emergency trauma situations. Founded in 2003, the company’s products include emergency response technology, simulation solutions and training aids.

CNL Strategic