What You Should Know about the New Stark Regulations: Overview of Significant Changes, Group Compensation and Value Based Arrangements

Time: 12:00 noon to 1:00 pm

Place: Cisco WebEx

This presentation will explore the much needed and overdue changes to the Stark Law that became effective in January 2021.  Long criticized as being too complex, overly burdensome, and inconsistent with the Law’s original intent, even the Law’s namesake, Representative Pete Stark, called for its repeal.  In updating the regulations, CMS has endeavored to reduce the regulatory burden on providers and modernize a healthcare system which has traditionally focused on a fee-for-service model.  In addition to providing an overview of some of the more significant changes, additions and clarifications that affect all health care providers impacted by the Stark Law, the presentation will address specific changes affecting Group Practices and how profits can be shared among physicians, as well as how the rules can be used to support value-based arrangements.

Paul Giancola. Paul Giancola’s practice is focused on regulatory matters,  compliance, and transactions (joint ventures,, management agreements, contacts,  ASCs)  for healthcare organizations and physicians, including medical staff matters, HIPAA, Stark, licensing board and government investigations, and fraud and abuse. He teaches Healthcare Fraud at the ASU Sandra Day  O’Connor College of Law.

Ben Runkle. Benjamin’s practice includes the representation of healthcare providers and organizations in a variety of matters. Prior to joining the legal profession, Ben worked as a firefighter/paramedic and police officer. His experience includes the following: Representation of behavioral health providers, physicians, dentists, and other healthcare professionals in government investigations and enforcement actions; Representation of physicians and dentists in administrative and licensing proceedings; Management of administrative appeals including provider-payor disputes, imposition of civil penalties and assessments, overpayment and recoupment matters, and service authorization denials; Representation of clients throughout all phases of criminal prosecution and appeal; As an Assistant Attorney General, prosecuted fraud and represented the Department of Economic Security in litigation and policy development; Advised the Arizona Health Care Cost Containment System, Arizona’s Medicaid agency, on litigation strategy, rule-making, provider registration, policy development, and compliance matters investigated by the Office of the Inspector General; and Representation of clients with respect to investigations by the Department of Health and Human Services, Office of Civil Rights.

Lauren Weinzweig is a partner at The Nelson Law Group, PLLC where she assists health care facilities, medical groups and other health care practitioners address many of the operational, regulatory and transactional issues facing the health care industry. Her practice has an emphasis on health care transactions, compliance with fraud and abuse laws, professional board investigation defense and health information privacy.  She has been recognized in Best Lawyers in America for Health Care Law since 2015 and has been honored to serve as a member of the Board of the Arizona Society of Healthcare Attorneys since 2013.  When not working, Lauren enjoys spending time with her family and dogs in Munds Park, Arizona.

Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx.  This program will be $10 for members and $15 for non-members.

To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.

  Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.

The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.

COVID’S Constitutional Conundrum: Assessing Individual Rights in Public Health Emergencies

Time: 12:00 noon to 1:00 pm

Place: Cisco WebEx

Considerable legal challenges alleging infringements of constitutional rights have arisen against governments imposing social distancing or other restrictive measures to quell the COVID-19 pandemic. Courts assess these claims largely under two variant approaches. Consistent with constitutional re-balancing, judges weigh the application of rights against governments’ compelling needs to protect public health and safety in emergencies. Alternatively, a minority of courts temporarily set aside existing rights to effectuate emergency responses. Neither approach is legally sufficient to the extent they fail to account for the flexible nature of rights and freedoms in exigencies. Rather, courts should engage in guided assessments focused on the execution, efficacy, and purpose of public health emergency interventions as a constitutional prerogative instead of examining alleged infringements of rights framed outside emergency contexts.

James G. Hodge, Jr., JD, LLM, is the Peter Kiewit Foundation Professor of Law and Director of the Center for Public Health Law and Policy at the Sandra Day O’Connor College of Law, Arizona State University. Through scholarship, teaching, and projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics, and human rights. Since September 2010, he also serves as Director, Western Region Office, Network for Public Health Law (funded by the Robert Wood Johnson Foundation). To date The Western Region Office has assisted public health lawyers, officials, practitioners, students, and others across 11 states and nationally on over 4,400 claims. 

Jennifer L. Piatt, J.D., (“Jen”) is a Research Scholar with the Center for Public Health Law and Policy at the Sandra Day O’Connor College of Law, Arizona State University, and a Senior Attorney with the Network for Public Health Law’s Western Region Office. Before joining ASU and the Network, Jen served as a law clerk to Vice Chief Justice Ann A. Scott Timmer of the Arizona Supreme Court and worked in private practice as a pharmacy regulatory attorney at Quarles & Brady LLP, in the firm’s Phoenix, Arizona office.

Due to the current social distancing recommendations, this program will be held via video conference through Cisco WebEx.  This program will be $10 for members and $15 for non-members.

To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.

  Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.

The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.

“Year In Review”

Time: 10:00 am to 12:00 pm

Place: Cisco WebEx

Program summary:

Kristen Rosati, Bob Homchick, and Michael Schaff will present this year’s “Year in Review” on February 12. As usual, this will be a fast-paced overview of developments over the past year, including:

• COVID-related legislation and regulatory waivers
• COVID-related claims and developing immunity
• COVID financial relief for providers and attendant risks
• COVID and the rise of telemedicine
• Health care reform: Significant Supreme Court decisions and status of the Affordable Care Act
• The Regulatory Sprint to Coordinated Care and the final regulations from CMS and OIG
• HIPAA and HIT developments: Information blocking and interoperability, proposed HIPAA regulations, and OCR enforcement
• Transparency Rules and Reimbursement Trends
• And more!

We hope you join us for a full two hours of CLE and irreverent observations.

Program logistics:

Due to the current social distancing recommendations, this program will be held via video conference on February 12, 2021 at 10:00 am through Cisco WebEx. This program will be $30 for members and $45 for non-members.

To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now.” This button will take you to a screen with multiple payment options. Please select your membership level. If you are a 2021 member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process.

Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.

The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 2 hours of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.

Speaker Bios:

Kristen Rosati, Partner, Coppersmith Brockelman PLC. Kristen is considered one of the nation’s leading “Big Data” and HIPAA compliance attorneys. She also has deep experience in data breaches, health information exchange, data sharing for research and clinical integration initiatives, clinical research compliance, and biobanking and genomic privacy. Kristen is a sought-after national speaker on these issues and has been active in national healthcare policy.

Kristen is a Past President of the American Health Law Association (AHLA).

Robert (Bob) Homchick, Partner, Davis Wright Tremaine. Bob is a partner in Davis Wright Tremaine’s national health care practice. As a health care transactional and regulatory lawyer, Bob counsels clients in areas such as physician self-referral (i.e., the federal Stark Law and its state law counterparts), regulatory compliance and fraud and abuse. Bob assists hospitals, physician organizations, ancillary services providers, and others in acquisitions, the formation and operation of joint ventures and in the development and implementation of new care delivery models, including accountable care organizations and other clinically integrated networks. His extensive experience includes defending providers in government audits, investigations, administrative proceedings and assisting providers with voluntary disclosures to federal and state enforcement agencies.

Michael F. Schaff, Shareholder, Wilentz, Goldman & Spitzer, P.A. Michael is co-chair of the Corporate and Health Law practice groups and a member of the Management Committee at Wilentz. In addition to a robust private practice spanning over 30 years, and having served as generate corporate counsel for many privately held companies, Michael brings to the table a multi-faceted understanding of the law, as well as a unique educational and professional background rooted in business, finance, and taxation. The depth of his experience enables Michael to assist his clients in evaluating both the legal and business ramifications of any transaction, contract, agreement or negotiation.

What Does Interoperability Mean?

Understanding Compliance with CMS’s Interoperability and Patient Access Final Rule

Time: 12:00 noon to 1:00 pm

Place: Cisco WebEx

Our speakers will be Susan Russo,AHCCCS, and Melissa Soliz,Coppersmith Brockelman.

Program summary:

The compliance date for the CMS Patient Access API and Provider API requirements is coming soon—January 1, 2021. CMS is exercising its enforcement discretion only until July 1, 2021. And the compliance deadlines for the CMS Conditions of Participation e-notification requirements and payer-to-payer exchange are not far behind. It is imperative that health plans and health care providers understand not only the legal requirements and who must comply, but the challenges with implementing them in compliance with federal privacy laws and practical limitations (such as technology and administrative processes).

Our speakers will cover the CMS final rule requirements for Patient Access API, Provider Directory API, payer-to-payer exchanges, and CMS CoP e-notification requirements. These requirements will be discussed against the backdrop of also complying with federal privacy and patient access law (such as HIPAA, 42 C.F.R. Part 2 and the new ONC Information Blocking Rule) and practical implementation concerns. Specifically, we will cover:

• The Patient Access API standards, including what must be made available to patients and when;
• To whom and in what manner covered plans are required to make the Patient Access API available, and the privacy and security concerns this implicates;
• The Provider API standards, including the use of public facing APIs;
• When and what level of participation is required in payer-to-payer exchanges, including what health information must be shared and how existing health information exchange (HIE) infrastructures might be leveraged to meet this requirement;
• What, when and to whom e-notifications must be sent under the new CoPs; and
• Ancillary topics, such as the requirement for states to send MMA file data daily, interaction with the CIOX decision on limited patient-directed third party disclosures, and Information Blocking compliance.

Program logistics:

Due to the current social distancing recommendations, this program will be held via video conference on November 20, 2020 at 12:00 p.m. through Cisco WebEx.  This program will be $5 for members and $10 for non-members.

To register, please visit our website https://azsha.org/, click upcoming programs, on the right you will see a button that says “Register for Next Program Pay Now”. This button will take you to a screen with multiple payment options. Please select your membership level. If you are a member, please login and proceed with the payment process. If you are not a member, you will have to create a username and password to continue with the payment process. If you are a member, but you paid your annual dues via check rather than online, please reach out to Mackenzie Mayfield to create an account for you, which will allow you to select the membership rate. 

Once you have registered online, you will receive a calendar invite containing the WebEx link. Please note, you don’t need to sign up for a WebEx Account to join a meeting.

The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.

Speaker Bios:

Susan Russo, is an in-house attorney at the Arizona Health Care Cost Containment System (AHCCCS), Arizona’s state Medicaid agency. Her work includes drafting language for contracts with health plans, supporting contract oversight, reviewing and advising on new state and federal laws, and representing AHCCCS in administrative hearings and settlement discussions. She has experience in government reimbursement, electronic health records, whistleblower investigations, and health care risk adjustment. Prior to joining AHCCCS, Susan was a consultant in healthcare payer disputes and investigations and clerked on the Arizona Court of Appeals. 

Melissa Soliz is a partner with Coppersmith Brockelman, PLC in Phoenix, Arizona. Her regulatory health law practice focuses on compliance with data privacy and patient access laws (such as HIPAA, 42 C.F.R. Part 2, the ONC Information Blocking Rule, the CMS Interoperability and Patient Access Rule, and state laws), compliance with opioid treatment laws and regulations, health information exchange (HIE), behavioral health/substance use disorder law issues, data breaches and OCR investigations, as well as clinical research compliance and contracting. Melissa regularly speaks in local and national forums on these topics and has been active in state and federal policy making on data privacy and HIE issues.