Author: Alissa Smith

Alissa represents health systems, hospitals, pharmacies, long-term care providers, home health agencies and medical practices, as well as nonprofit and municipal organizations. Alissa’s transactional practice includes contracts, leases, mergers, acquisitions and joint ventures. Alissa’s regulatory practice includes the interpretation and application of state and federal fraud and abuse laws, Medicare and Medicaid rules, tax-exemption laws, HIPAA and privacy laws, EMTALA laws, licensing matters, employment laws, governmental audits and open records and open meetings matters. She also assists with corporate and health system governance issues, including the revision and negotiation of medical staff bylaws.

Biden Administration Orders Long Term Care Facilities to Require COVID-19 Vaccinations To Receive Federal Funds; OSHA Issues Updated COVID-19 Recommendations For All Workplaces

As we have previously written, the landscape for employers in the time of COVID-19, particularly health care employers and long term care facilities, is ever-changing and quickly moving.  In the last year, health care employers have had to navigate state laws, Centers for Disease Control and Prevention (“CDC”) and Centers for Medicare & Medicaid Services...

Update Regarding Publication of OSHA Emergency Temporary Standard

On June 10, 2021, Dorsey’s Labor & Employment attorneys outlined an Emergency Temporary Standard (“ETS”) issued by OSHA.  At the time, the ETS was not an official regulation because it had not yet been published in the Federal Register.  On June 21, 2021, the ETS was published and, for covered healthcare employers, the compliance clock...

Considerations for Health Care Employers under Iowa’s Vaccine Passport Law and Recent CDC, CMS and EEOC Guidelines

One of the last pieces of legislation the Iowa legislature sent to Governor Kim Reynolds’ desk for guaranteed signature was a bill banning vaccine passports in Iowa.  House File 889 contains several prohibitions regarding inquiries into a person’s COVID-19 vaccine status.  For entities that contract with the state government or otherwise receive state funding, the...

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

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “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 new or proposed...

White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations

In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect.  These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes...

The Regulatory Sprint Catches up to HIPAA: New Proposed HIPAA Rules

Today, the Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) which proposes significant changes to the Health Insurance Portability and Accountability Act (“HIPAA”) and to the Health Information Technology for Economic and Clinical Health Act (“HITECH”) Privacy Rule (the “Privacy Rule”).  The NPRM includes...

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

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!

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...

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

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...

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers

As we explained in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. On April 21, 2020, CMS issued explanatory guidance, available...