Author: Alissa Smith

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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.

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

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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

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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

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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”

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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!

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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

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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

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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...

The Paycheck Protection Program and Health Care Enhancement Act: Summary of “Phase 3.5” COVID-19 Stimulus Package

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On Friday, April 24, 2020, President Trump signed into law the “Paycheck Protection Program and Health Care Enhancement Act,” colloquially referred to as “Phase 3.5.” Phase 3.5 comes on the heels of three much larger bills passed into law intended to address the effects of the ongoing coronavirus pandemic. The first three phases, the Coronavirus...

OIG Initiatives to Ease Provider Burdens Related to COVID-19

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The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has taken numerous steps to minimize regulatory burdens for providers who need to make their primary focus delivering patient care during the COVID-19 national emergency. These steps, along with recent steps taken by other agencies to provide temporary regulatory flexibility, provide further...