The 340B Program, named after its section within the 1992 Public Health Service Act, allows covered entities to stretch their scarce federal resources as far as possible, by setting  a ceiling price on the sale of covered outpatient drugs from participating pharmaceutical manufactures to covered entities. With the passage of the Patient Protection and Affordable Care Act in 2010, 340B’s oversight agency, the Health Resources and Services Administration (“HRSA”) within the Department of Health and Human Services (“HHS”), was directed to establish an administrative dispute resolution (“ADR”) process. Covered entities and pharmaceutical manufactures would then use the ADR process to settle claims such as drug overcharging, diversion, or duplicate discounts. It took ten years, but HHS has finally taken action.
Continue Reading The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

On November 20, 2020, the U.S. Department of Health and Human Services (“HHS”) released final rules seeking to modernize the Physician Self-Referral Law (“Stark Law”) and the federal Anti-Kickback Statute (“AKS”).

The final rules, released by HHS’ Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”), are part of The Regulatory Sprint to Coordinated Care—an effort launched by HHS in 2018 aimed at removing barriers to value-based care. Among other changes, the final rules add new value-based exceptions to the Stark Law and additional safe harbors under the AKS. The important changes to the Stark Law and AKS are highlighted below.
Continue Reading HHS Final Rules Modernize the Stark Law and Anti-Kickback Statute to Usher in Value-Based Care

On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act or “CARES Act” which includes $100 billion in relief funds for hospitals and other healthcare providers to be used to provide support for healthcare-related expenses or lost revenue attributable to COVID-19. Funding is also available to providers to assist uninsured individuals to obtain testing and treatment for COVID-19.
Continue Reading DHHS Issues Terms and Conditions for Relief Funds

The federal government continues to develop responses to the evolving COVID-19 pandemic and now turns toward combatting COVID-19 related fraud. Attorney General Barr issued a memo on March 16, 2020 calling on all U.S. Department of Justice (“DOJ”) attorneys to prioritize the detection, investigation, and prosecution of wrongdoing related to COVID-19. Following Attorney General Barr’s instruction, the U.S. Attorney for the Northern District of Illinois appointed a federal prosecutor to lead the district’s crackdown of scammers attempting to leverage the pandemic for fraudulent purposes. U.S. Attorney’s Offices across the country are expected to follow this path to coordinate with federal, state, and local law enforcement partners to lead fraud investigations and enforcement.
Continue Reading Fighting Fraud in the Wake of COVID-19

On March 3, 2020, Attorney General William Barr announced the National Nursing Home Initiative–a new U.S. Department of Justice (“DOJ”) taskforce organized to push criminal and civil enforcement action against nursing homes across the country. The initiative will help coordinate DOJ enforcement actions against nursing homes that provide “grossly substandard care.”
Continue Reading The National Nursing Home Initiative: New DOJ Taskforce Bolsters Nursing Home Enforcement

The U.S. Department of Justice (“DOJ”) has resolved false claims against a sector not typically prone to FCA attacks—research institutions. In December 2019, the DOJ reached a $5.5 million settlement agreement with a Michigan non-profit research institute, the Van Andel Research Institute (“VARI”). The DOJ alleged that VARI failed to disclose foreign funding upon the application for, and over the term of, a federal grant.
Continue Reading The False Claims Act Goes Abroad: Michigan Research Institute Falls Under DOJ False Claims Act Scrutiny

Recent ransomware attacks illustrate the importance of compliance with the HIPAA required and addressable security standards. In its December 2, 2019 Fall 2019 Cybersecurity Newsletter, the Office of Civil Rights (OCR) discussed ransomware attacks and ways to recognize, prevent, mitigate and recover from an attack.
Continue Reading Cybersecurity Attacks: The Importance of Compliance With the Standards