The Federal Anti-Kickback Statute (“AKS”) is a criminal statute that prohibits transactions intended to induce or reward referrals for items and services reimbursed by federal health care programs (such as, Tricare, Medicare, and Medicaid). On November 20, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule that amends…
On November 20th, 2020, the Centers for Medicare & Medicaid Services (CMS) made sweeping changes to the Stark Law through the issuance of a new “Final Rule,” which is an essential mile-marker in the government’s Sprint to Coordinated Care. Many industry stakeholders have been eagerly awaiting the Final Rule’s issuance, hoping that it would provide more flexibility and clarity to this complex…
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposed updates aim to give patients more access to their health information and improve coordinated care, while also ensuring that patients are afforded privacy and security…
Gov. Jared Polis entered Executive Order D 2020 249 to clarify the order of operations for the increasing hospital capacity in the State of Colorado. Hospitals were directed to increase their capacity internally by utilizing unused space and supplementing their staffing. If further capacity is needed, the hospitals were directed to decrease the number of elective procedures being performed at the…
Three separate price transparency rules have been published or go into effect soon. Hospitals and insurers need to prepare for compliance and all of the legal issues that will arise during implementation of the rules.
The Hospital Price Transparency Rule
Beginning January 1, 2021, the Hospital Price Transparency Rule (“Hospital Transparency Rule”) goes into effect, requiring all hospitals, as…
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited final rules on November 20, 2020. The final rules revise the Medicare Physician Self-Referral law (Stark law), the Federal Anti-kickback statute, and the Civil Monetary Penalties Rules.1 Each agency has issued a Fact Sheet highlighting the…
The Office of the National Coordinator extended compliance deadlines to its 21st Century Cures Act: Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”). This extension postpones compliance requirements for the Information Blocking provisions that were set to go into effect November 2, 2020 until April 5, 2021. Clearly this provides…
On November 16, 2020, the HHS Office of Inspector General (“OIG”) issued a special fraud alert regarding “the offer, payment, solicitation, or receipt of remuneration” relating to speaker programs for pharmaceutical and medical device companies.
The targeted speaking engagements involve programs presented by physicians or other healthcare provider, who are not employed by the company, and the…
Litigants and litigators face unique challenges to effectively prosecute or defend ongoing or anticipated civil actions amid the pandemic. Now, more than seven months since the declaration of a national emergency in the U.S. and with new COVID-19 cases continuing to rise in many regions, flexibility and creativity remain critical to adapt to the evolving nature of one’s “day in court” during…
A recent decision from the District of Columbia’s Court of Appeals has paved the way for the United States Department of Health and Human Services (“HHS”) to continue its policy of Medicare Part B reimbursement reductions for 340B covered entities.
Background
Congress created the 340B drug pricing program in 1992, requiring certain pharmaceutical manufacturers to sell outpatient drugs at discounted…
On October 1, 2020, The Department of Health and Human Services (“HHS”), through the Health Resources and Services Administration (“HRSA”) announced the disbursement of another $20 billion in financial relief for certain physician practices and other health care delivery organizations and clinicians who are part of the Coronavirus Aid, Relief and Economic Security Act (“CARES”). Providers will…
The time is now for compliance teams to review their systems, policies, and procedures to ensure they are ready to comply with the Final Rule on Information Blocking (the “Final Rule”)1 issued by the Office of the National Coordinator for Health Information Technology (ONC) in March of this year. The Final Rule stems from the 21st Century Cures Act (the “Cures Act”),2 which was passed by…
