Health Law Committee February Newsletter
IN THIS ISSUE...
> Message from the Chair, Kenny A. Johnson  
> Your Health Law Committee Leadership Team (2015-16)  
> ACC Health Law Committee Upcoming Events and Quick Hits  
> ACC Health Law Committee Previous Events and Quick Hits  
> eGroups  
> Sponsor’s Corner – Foley & Lardner, LLP  
> Aspiring Writers  
> Job Listings  
Networks
Virtual Library
Renew Your Membership
Update Your Records
Upcoming ACC Programs
Search Back Issues

Webcasts
Updates From ACC Committees

Message from the Chair, Kenny A. Johnson

Greetings and hope this message finds all of you well. On behalf of the Health Law Committee (HLC), I am excited to announce the publishing of our first inaugural Health Law Committee newsletter. Through this newsletter, our goal is to provide an additional vehicle to communicate to all of you upcoming events, articles of interest, member updates, and pictures and summaries of past events to help keep our membership apprised of all the things our committee has to offer. I especially want to say a big thank you to Michael Brody, the HLC Communications chair, for his hard work in getting our first newsletter up and running.

As Chair of the HLC, I am privileged to work with a great leadership team and a great sponsor - Foley & Lardner.  Collectively, we have worked hard over the last few months to make sure we continue to provide our members with quality programs, events, and networking opportunities.  As examples, we have finalized the Legal Quick Hit schedule for the remainder of the year, will be offering another Health Law track at the 2016 Annual meeting in San Francisco, will host our Second Annual Regulatory Summit in Washington DC in April, have held two successful meetings (with more planned) with the Office of the National Coordinator for Health Information Technology (ONC), and have plans for additional local and pro bono initiatives with various Chapters throughout the United States.  Additionally, we are in the planning stages of creating an international committee to ensure we broaden our focus to meet the needs of our international members as ACC continues to expand its global presence.

In closing, your leadership team remains committed to helping provide all of you with the resources and information needed to help you excel in your in-house role.  Our hope is that this newsletter will be another vehicle to help achieve those ends.  Also, to help us in serving your needs, we always appreciate any feedback or suggestions you have.  And, if you are interested in becoming more involved in leadership or contributing materials, articles, or resources for publication, please do not hesitate to reach out to me, any other member of the leadership team, or by e-mailing us at hlc@acc.com.

Thanks again.

Kenny Johnson
Chair, Health Law Committe
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Your Health Law Committee Leadership Team (2015-16)

Position

Name

Chair

Kenny A. Johnson, Senior Corporate Counsel. Quest Diagnostics Incorporated

Vice-Chair

K Royal, VP, AGC Privacy and Compliance, CellTrust Corporation

Secretary

Jane Orenstein, Director of Legal, Regulatory and Compliance Services, Delta Dental of Washington

Advocacy Chair

Alan Albright, Associate General Counsel, Anthem, Inc.

Communications Chair

Michael Brody, Associate General Counsel, UnitedHealthcare

Membership Chair

Erich Drotleff, Director, Healthcare Legal Counsel, Sutherland Healthcare Solutions

Pharmaceutical Industry Subcommittee Co-Chair

Michele Atchison, Chief Compliance Officer & Corporate Counsel, TrialCard

Pharmaceutical Industry Subcommittee Co-Chair

Debra Bromson, Senior Corporate Counsel and Head of Global Privacy, Jazz Pharmaceuticals

Medical Device Industry Subcommittee Chair

Lisa Castleton, Senior Counsel, St. Jude Medical, Inc.

Academic Medical Centers Subcommittee Co-Chair

Scott Shuman, Director of Legal Affairs, Pacific University

Academic Medical Centers Subcommittee Co-Chair

Mark Tatelbaum, Vice President & General Counsel, Ameritox Ltd

Health Information Management  Subcommittee Co-Chair

Asma Hasan, Chief Legal Officer, HealthTrio, LLC

Health Information Management  Subcommittee Co-Chair

Manuj Lal, General Counsel, PatientPoint

Privacy Subcommittee Co-Chair

K Royal, VP, AGC Privacy and Compliance, CellTrust Corporation

Privacy Subcommittee Co-Chair

Jason Stevens, Assistant General Counsel, Novant Health, Inc.

Hospitals/Providers Subcommittee Chair

Laurie Weinstein, Managing Counsel, The Permanente Medical Group, Inc.

Immediate Past President

Gavin Galimi, Executive Vice President, General Counsel, and Chief Compliance Officer, March Vision Care, Inc.


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ACC Health Law Committee Upcoming Events and Quick Hits

Let’s Make a Deal: A Door-to-Door View into US Healthcare Mergers & Acquisitions (Monthly Quick Hit)
Tuesday, April 5, 2016 at 12:00 PM ET
To register, please click here.

2016 ACC Mid-Year Meeting
April 10-12, 2016
New York Marriott Marquis
New York City
For further details and registration, please click here.

Global Look at Physician Payment Transparency Reporting (Monthly Quick Hit)
Tuesday, May 3, 2016 at 12:00 PM ET
To register, please click here.

University Affiliation Agreements (Monthly Quick Hit)
Tuesday, June 7, 2016 at 12:00 PM ET
To register, please click here. 

Second Annual Regulatory Summit
Spring 2016 (exact dates to be determined)
Washington, D.C.

2016 ACC Annual Meeting
October 16-19, 2016
Moscone Center
747 Howard Street
San Francisco, California 94103
For further details and registration, please click here.

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ACC Health Law Committee Previous Events and Quick Hits

What is on the US Office of Inspector General (OIG) Radar for its 2016 Work Plan (March 1, 2016)

Looking Back to 2015 – What We Learned and Loved (February 2, 2016)

Let’s Stark the New Year Right: Updates to US Stark Law (January 5, 2016)

 

Agendas and Presentations may be found here.
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eGroups

The Health Law Committee is nearly 2,000 members strong, and one of our best resources is each other. The eGroup postings are a forum for members to exchange ideas, share best practices, template forms, and many other resources. Members may submit eGroup inquiries, and any member may respond. If you are concerned about using your name, you may respond anonymously. And eGroup responses are informational only, and are not considered legal advice or counsel.  We highly recommend that you take advantage of this resource. Postings may be found here. If you have questions or need assistance, contact Communications Chair Michael Brody.
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Sponsor’s Corner – Foley & Lardner, LLP

Understanding the New CMS Final 60-Day Overpayment Refund Rule

Torrey Young, Esq., Jana Anderson, Esq., Larry Vernaglia, Esq., Foley & Lardner, LLP

Four years after the issuance of the Proposed Rule and six years after the authorizing statute, CMS has published the much-awaited Final Rule regarding the reporting and returning of Medicare Part A and B overpayments (the “Final Rule”).  81 Fed. Reg. 7654-7684 (Feb. 12, 2016).  Since the inception of Section 6402(a) of the Affordable Care Act (“ACA”), there has been confusion among providers, lawyers, regulators, and courts regarding the requirements, scope, and impact of Social Security Act section 1128J(d), which requires a person who has received an overpayment to report and return the overpayment within 60 days of identification or the date any corresponding cost report is due.   CMS issued the Final Rule with the goal to provide clear requirements for persons to report and return Medicare overpayments under section 1128J(d)’s “60-Day Rule.”

What:

Section 1128J(d) of the Act created an express duty to refund and report Medicare and Medicaid overpayments by the later of 60 days after the overpayment was “identified” or the date the cost report is due.  Failure to report and return the overpayment is an obligation for the purpose of the False Claims Act (31 U.S.C. § 3729(a)(1)(G)).  The Final Rule only applies to overpayments from traditional Medicare - Parts A & B.  States are implementing their own policies on return of Medicaid overpayments.  CMS previously issued regulations on the duty of Medicare Parts C and D plans to return overpayments they receive to CMS.  See 81 Fed. Reg. at 7655 (citing 70 Fed. Reg. 29844). 

The Final Rule contains a lot of detail regarding the application of the 60-Day Rule requirements.  What follows is a summary of the top two blockbuster clarifications made – the look-back period and what it means to “identify” an overpayment. 

Look-back Period

What had been unclear from the statute was the look-back period for any retained overpayments.  The Proposed Rule offered a 10-year look-back period, based on the “outer limit” of the False Claims Act’s statute of limitations.  Historically, providers have resolved innocent overpayments using the four-year reopening period.  The Final Rule splits the difference, settling on a 6-year look-back period.  The 6-year look-back is not retroactive, and will be effective March 14, 2016.  See 81 Fed. Reg. at 7671.  This is an extremely important issue for providers and their counsel to consider if they may be making refunds prior to March 14.  

For consistency, CMS also included language concerning reopenings under the Final Rule in 42 C.F.R. § 405.980(c)(4), which have been extended to 6 years as well and which are limited to reopenings by the provider or supplier under 42 C.F.R. § 401.305.  See 81 Fed. Reg. at 7673.

“Identify”

The heart of most discussions regarding the 60-Day Rule has been: what does it mean to “identify” an overpayment? “Identify” was not defined in section 1128J(d) of the Act, so we were left wondering when the clock starts.  Was it when the first “whiff” of an overpayment came to someone’s attention?  Was it when, for example, there was a compliance hotline allegation?  Or was the overpayment identified sometime later, such as when the allegation was verified to be a billing error, or the moment at which an overpayment was quantified. 

The Final Rule addresses this through CMS’s decision that providers have an obligation to exercise “reasonable diligence” through “timely, good faith investigation of credible information.”  81 Fed. Reg. at 7662.  CMS clarified that this means both proactive and reactive reviews of Medicare billing – in other words, merely auditing based on compliance hotline calls or issues raised by staff is insufficient.  See id. at 7664.

The 60-day clock does not start running until after the reasonable diligence period has concluded, which may take “at most 6 months from receipt of credible information, absent extraordinary circumstances.”  81 Fed. Reg. at 7662.  The Final Rule acknowledges that complex investigations like a Stark Law violation that are referred to the CMS Voluntary Self-Referral Disclosure Protocol fall within this “extraordinary circumstances” category.  Lastly, and perhaps most important for providers, an overpayment is not “identified” until the amount of the refund has been “quantified.”  See id. at 7661.  That means in ordinary cases, there will be an 8-month period – 6 months for timely investigation (reasonable diligence) plus 60 days for reporting and returning the overpayment, again absent an extraordinary circumstance or complex investigation, which may require a longer reasonable diligence period.

Failing to make reasonable diligence efforts, including failure to conduct reasonable diligence after obtaining the information, may result in the provider or supplier improperly retaining an overpayment because it acted in reckless disregard or deliberate ignorance of whether it received such an  overpayment.  See id. at 7659.  That overpayment liability can, in turn, result in Federal false claims act liability under 31 U.S.C. § 3729(a)(1)(G) as a “reverse” false claim.

When:

The Final Rule will be effective March 14, 2016. The Final Rule is not retroactive, though CMS advises providers and suppliers that the ACA statutory requirements have been in effect since 2010.  See 81 Fed. Reg. at 7673.  This means that all providers and suppliers reporting and returning overpayments on or after March 14, 2016 – even overpayments received prior to March 14, 2016 – must comply with the new regulatory requirements, including the six-year lookback, discussed above.  See id.

Who:

The Final Rule is in effect for Medicare Part A and Part B providers and suppliers. Medicare Parts C & D Plans and Prescription Drug Plan sponsors are subject to a separate rule that was issued in May 2014.  See 81 Fed. Reg. at 7655 (citing 70 Fed. Reg. 29844).  No final rule has been published that addresses Medicaid requirements.  See id.
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Aspiring Writers

Health Law Committee members who are interested in authoring a blog post, an on-line article or an ACC Docket article are more than welcome. If you are interested, please contact our Communications Chair, Michael Brody.
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Job Listings

For current career opportunities in the in-house health care law, please click here.
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