Dorsey Health Law Blog

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...

Reimbursement for Remote Patient Monitoring Services in 2019

Medicare reimbursement for remote patient monitoring has taken a number of steps forward throughout this year. New and proposed rules from the Centers for Medicare and Medicaid Services both expand the billing options available to health care providers and also build in additional flexibility in the provision of remote patient monitoring in order to further...

CCPA Compliance Screening and Assessment Tools–Now Available

From Robert Cattachach, a Dorsey Partner with our Regulatory Affairs Group: I am pleased to announce that Dorsey has launched web-based CCPA Screening and Assessment Tools to help organizations in preparing for the California Consumer Privacy Act (CCPA), which goes into effect on January 1, 2020. Companies can determine whether the CCPA will apply to...

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA): A New Federal Kickback Law Applicable to All Payors

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. § 220.  As part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, EKRA was enacted in response to a concern that the federal Anti-Kickback Statute...

Q&A: Financial Restructuring and Healthcare Providers

Any casual reader of healthcare news in recent years has taken note of the upheaval and financial uncertainty facing healthcare providers. Take for example a recent Bloomberg story detailing the closure of Hahnemann University Hospital in Philadelphia – “Philadelphia Hospital Collapse Highlights Healthcare ‘Anarchy’”. Anarchy or not, closures, consolidations, and financial restructuring are all too...

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May 2018, the Trump administration spoke on drug pricing and published its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs”. One of...

Minnesota Enacts New Assisted Living Facility Law

On May 22, 2019, Minnesota Governor Tim Walz signed a significant new assisted living licensure bill into law. Previously in Minnesota, assisted living facilities were required to register with the Minnesota Department of Health (the “Department”) but were not subject to facility licensure. The new law requires assisted living facilities to be licensed, with special...