Dorsey Health Law Blog

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

Laura B. Morgan

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published...

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

Ross C. D'Emanuele

The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical device companies organize and fund. These programs are typically company-sponsored events at which one or more physicians or other health care...

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

Laura B. Morgan

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...

2020’s a Bust, but HIPAA Enforcement Is on a Roll!

Elizabeth Greiter

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been actively enforcing HIPAA regulations this year, including a series of seven settlements under OCR’s Right of Access Initiative to enforce patients’ rights to timely access their medical records at a reasonable cost. This year, OCR has recorded...

Finalized Rule to Remove Disincentives to Living Organ Donation

Randall Hanson

On September 22, 2020, the Department of Health and Human Services (“DHHS”) finalized a new rule to expand the scope of qualified reimbursable expenses incurred by living organ donors to include lost wages, child-care expenses, and elder-care expenses. The new rule goes into effect on October 22, 2020, and is a win for living organ...

CMS Issues Interim Final Rule to Enforce COVID-19 Reporting Requirements

Jamie McCarty

The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements.  The final rule also modifies various aspects of Medicare reimbursement methodologies for health plans, physicians, and other providers.  This post summarizes each of...

DOJ Demonstrates Continued Focus on Opioid Crisis with $600 Million Criminal and Civil Settlement Against Indivior Solutions, Indivior Inc., and Indivior plc

Vanessa J. Szalapski

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. We would like to thank Vanessa J. Szalapski for the following post...

Is Your Compliance Program More than a Paper Program? DOJ Issues Revised Guidance for Evaluating Corporate Compliance Programs

Laura B. Morgan

On June 1, 2020, the Department of Justice (“DOJ”) issued an updated version of its “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), available here. The DOJ Guidance is an update to guidance first issued by the DOJ in February 2017 (which we described in our prior blog post), and was last updated by the...

Top Three Current Revenue Stream Considerations for Tax-Exempt Organizations Providing Elder Care

Mackenzie McNaughton

Current economic conditions have put additional strain on organizations across the health care spectrum in unprecedented ways. However, along with new challenges, both market conditions and new guidance from the Internal Revenue Service (IRS) bring fresh opportunities for tax-exempt senior services and other elder care organizations to consider new efficiencies, maximize revenues, and even expand...