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October 
18
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Around the Corner in Digital Health:
What's Next for Care Coordination and Reimbursement

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This podcast explores:

• Goals of the Regulatory Sprint to Coordinated Care
• The current digital health reimbursement structure and its impact on patient care and patient costs
• Key risk and compliance areas digital health companies need to address in 2019 and beyond
• Issues for digital health companies to consider when developing business plans
• Collaborations between digital health companies and other healthcare players

Alex Zahradnik is a host of exceptional ability. Studies show that a vast majority of guests attending events by Alex have been known to leave more elated than visitors to Santa's Workshop, The Lost of Continent of Atlantis, and the Fountain of Youth.

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

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FINAL RULES
PROPOSED RULES
PODCAST
TEAM
Regulatory Sprint Resources
November 
29
, 
2018
6:00pm
–
10:00pm
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Discover how MWE can help you deliver great services and experiences. The must‑attend event in Philadelphia is the place to learn, connect, and get inspired by visionaries, customers, and partners. This complimentary program offers keynote presentations, educational sessions, access to our partner ecosystem and additional networking opportunities.

Regulatory Sprint
To Coordinated Care

Your Resource Center For The Government's Initiative On Care Coordination

September 
16
–
September 
18
Starting at 
10:00am
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FINAL RULES

Starting your own business and picking the right niche in no time

Discover how MWE can help you deliver great services and experiences. The must‑attend event in Philadelphia is the place to learn, connect, and get inspired by visionaries, customers, and partners. This complimentary program offers keynote presentations, educational sessions, access to our partner ecosystem and additional networking opportunities.

Reducing the Burden: Noteworthy Changes to the Stark Law

Making Sense of the Stark Law and AKS Final Rules: Top Changes You Need to Know

Reducing the Burden: Noteworthy Changes to the Anti-Kickback Statute

Title

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Law. As part of these final rules, the agencies liberalized the requirements under the existing exception and safe harbor for donations of electronic health record items and services, and created a new exception and safe harbor to allow donations of cybersecurity technology and related services.

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OCR Issues Proposed Modifications to HIPAA Privacy Rule to Remove Barriers to Coordination of Care and Reduce Regulatory Burden

On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) adopted under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act (collectively, HIPAA). The proposed modifications support individuals’ engagement in their care, remove barriers to coordinated care and reduce regulatory burdens in the health care industry under HHS’s Regulatory Sprint to Coordinated Care.


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HHS Finalizes Sweeping Changes to the Stark Law and the Anti-Kickback Statute Regulations

On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalty Law (CMPL) (collectively, AKS Rule). The Stark and AKS Rules finalize, with some modifications, most of the proposed changes promulgated by the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of Inspector General (OIG), respectively, in October 2019. These final rules represent arguably the most significant changes to these regulations in the last decade. This On the Subject provides a high-level overview of key provisions in the Stark and AKS Rules. 

 

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ONC Extends Compliance Date for Information Blocking Rule

On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that extends certain compliance dates included in ONC’s May 1, 2020, final rule implementing the 21st Century Cures Act. Among other things, the ONC interim final rule pushed the compliance date for ONC’s information blocking provisions from November 2, 2020, to April 5, 2021. The interim final rule did not make substantive changes to the information blocking provisions or ONC’s Health IT Certification Program.


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PROPOSED RULES

VIDEOS & WEBINARS

APIs and Information Blocking: What Healthcare Providers Need to Know

McDermott Will & Emery, along with The Chartis Group, discuss API requirements, their intersection with the information blocking prohibition of the ONC Final Rule, and actions you and your healthcare organization can take to be prepared for compliance.

Digging Deeper into Proposed Stark Physician Compensation Changes

The recently released Stark Law updates from the Centers for Medicare and Medicaid Services propose significant changes to physician compensation models. This video digs deeper into three aspects of the proposed rule.

Tips for Submitting Effective Comments on Regulatory Sprint Proposed Rules

McDermott lawyers who previously held roles at CMS, HHS and OIG share their insights on how industry stakeholders can provide effective comments on the proposed rules released by HHS as part of the Regulatory Sprint to Coordinated Care.

The Proposed Stark Rule: Did CMS Reduce the Burden

The recently released Stark Law updates from the Centers for Medicare and Medicaid Services propose significant changes to physician compensation models. This video digs deeper into three aspects of the proposed rule.

Value-Based and Patient Engagement Proposals in the HHS Sprint Rulemaking


Proposed Stark and AKS Modifications Affecting Health IT and Non-Value-Based AKS Proposals


Webinar: Exploring CMS's Interoperability Final Rule


Webinar: Exploring ONC's Final Information Blocking Rule


Webinar: Navigating the New ONC Requirements for APIs


Starting your own business and picking the right niche in no time

Discover how MWE can help you deliver great services and experiences. The must‑attend event in Philadelphia is the place to learn, connect, and get inspired by visionaries, customers, and partners. This complimentary program offers keynote presentations, educational sessions, access to our partner ecosystem and additional networking opportunities.

PODCASTS

Insights On Key Topics

STARK LAW

Government Resources on the Proposed Rules


CMS Proposed Rule Fact Sheet: Modernizing and Clarifying the Physician Self-Referral Regulations

 

McDermott Insights and Analysis


The Sprint to Modernize and Clarify the Stark Law - Part II
©Copyright 2020, American Health Lawyers Association, Washington, DC. Reprint permission granted.


The Sprint to Modernize and Clarify the Stark Law – Part I
©Copyright 2019, American Health Lawyers Association, Washington, DC. Reprint permission granted.

Stark Law and Anti-Kickback Statute Proposed Rules Would Facilitate Donations of EHR and Cybersecurity Technology and Services


A Closer Look at Proposed Changes to the Stark Law, the Anti-Kickback Statute and the Civil Monetary Penalties Law

 

HHS Proposes Substantial Changes to the Stark Law and the Anti-Kickback Statute Regulations

 

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

 

CMS Seeks Comments on Stark Law Reforms Needed to Reduce Obstacles to Innovation

ANTI-KICKBACK STATUTE AND CIVIL MONETARY PENALTIES

What a Difference a Year Makes—Key Anti-Kickback Statute and Stark Law Developments
Journal of Health Care Compliance, July - August 2020.


Key Takeaways from OIG’s AKS Sprint Proposed Rule
©Copyright 2020, American Health Lawyers Association, Washington, DC. Reprint permission granted. 


OIG Proposed Rule Fact Sheet: Revisions to the Safe Harbors under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement

 

Dash to Digital Health? How the Regulatory Sprint to Coordinated Care Could Expand Access to Care

 

OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care


Anti-Kickback Statute RFI

HEALTH IT / PRIVACY

Could Offering EHR System Access to Community Providers Lead to Civil Monetary Penalties for Information Blocking?

 

Advisory Board / McDermott Will & Emery Webinar | How to Figure Out Your Information Blocking Exposure: Which Penalties and Disincentives Might Apply to You


Analyzing Fee Restrictions for Health IT and EHI Under ONC's Final Information Blocking Rule


ONC Releases Final Rule Implementing Cures Act Information Blocking Prohibition


ONC and CMS Delay Enforcement Dates for Certain Provisions of the 21st Century Cures and Interoperability Final Rules, and OIG Announces Proposed Rule to Implement Information Blocking Enforcement Authority


CMS Final Rule Aims to Advance Interoperability, Exchange of Clinical and Plan Information

 

SAMHSA Proposed Rule Would Reduce Barriers to Care Coordination


HHS Announces Quality Summit to Streamline and Improve Quality Programs across Government


CMS Releases Proposed Rule to Advance Interoperability and the Exchange of Medical Record and Plan Information

 

Analyzing ONC ’s Proposed Rule: Fee Restrictions for Health IT and EHI


Office of Civil Rights’ Request for Information seeking to modify HIPAA rules to improve coordinated care

MANAGED CARE

CMS Seeks to Provide Flexibility and Facilitate Innovation in Medicare Advantage and Part D

MANAGED CARE

of digital interest Podcast

Preparing for the 21st Century Cures Act and Information Blocking:

Open Notes, APIs and More

With compliance dates recently pushed back to April 2021, this episode of the Of Digital Interest podcast features McDermott Health Law partners James Cannatti and Scott Weinstein, Chartis Group principal Chelsea Wyatt and associate principal Claudia Miller, and McDermott’s Chief Marketing Officer Leslie Tullio as they discuss healthcare data accessibility and other key issues healthcare providers should keep in mind to comply with new regulations, including:

 

·  Scenarios in which a request for open notes might occur and key exceptions to a required response

·  Guidance for providers regarding clinical notes accessibility for patients

·  Compliance options for handling active requests from various input portals

·  Who holds ultimate ownership for ensuring that open notes are shared when requested

·  Healthcare goals with the implementation of APIs

·  The types of data and notes to be shared under the USCDI standard

·  Anticipated HIPAA compliance challenges associated with patient requests for shared notes

·  Scenarios that will denote a need for physician training on improving their shared notes

Around the Corner in Digital Health:
What's Next for Care Coordination and Reimbursement

Around the Corner in Digital Health:
What's Next for Care Coordination and Reimbursement

This podcast explores:

• Goals of the Regulatory Sprint to Coordinated Care
• The current digital health reimbursement structure and its impact on patient care and patient costs
• Key risk and compliance areas digital health companies need to address in 2019 and beyond
• Issues for digital health companies to consider when developing business plans
• Collaborations between digital health companies and other healthcare players

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TEAM

JAMES A. CANNATTI III

PARTNER | WASHINGTON, DC

LISA MAZUR

PARTNER | CHICAGO

DANIEL H. MELVIN

PARTNER | CHICAGO

JOAN POLACHECK

PARTNER | CHICAGO

TONY MAIDA

PARTNER | NEW YORK

MONICA A. WALLACE

PARTNER | CHICAGO

SCOTT A. WEINSTEIN

PARTNER | WASHINGTON, DC

NICHOLAS FRANCIS ALARIF

PARTNER | WASHINGTON, DC

CHELSEA M. RUTHERFORD

ASSOCIATE | WASHINGTON, DC

MARA McDERMOTT

 VICE PRESIDENT

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DIRECTOR

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SENIOR DIRECTOR

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