First Healthcare Compliance CONNECT May 2022

CONNECT 

May 2022 

 

A Monthly Publication for the Healthcare Compliance Community 

CIAs, Exclusions, 

and Your Practice 

What to know about 

Operating Clinical 

Laboratories 

– Nuts and Bolts 

Revenue Cycle and 

Compliance Summit 

Let’s Talk About Sex, Baby: 

Common Mistakes and Pitfalls 

When Addressing Sex and 

Pregnancy Discrimination in the 

Workplace 

Julie Sheppard on the 

Importance and Value of 

HCCA Membership 

1st Talk Compliance: 

Medical Error & Patient 

Advocacy – How Can We Have 

More Candor?

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In This Issue: 

CIAs, Exclusions, and Your Practice 

What to know about Operating Clinical 

Laboratories – Nuts and Bolts 

Revenue Cycle and Compliance Summit 2022 

Let’s Talk About Sex, Baby: Common Mistakes 

and Pitfalls When Addressing Sex and 

Pregnancy Discrimination in the Workplace 

2 

First Healthcare Compliance, LLC © 2022

Compliance Super Ninja 

Kristy Phillips, Office Administrator 

James E. Fox M.D. PLLC 

How would you describe your experience with First Healthcare Compliance? 

My experience has been great! The use of this compliance program has made compliance something that 

is much more manageable. The ability to continually track compliance, licensure, and other necessary 

components is one less thing off my plate as a practice administrator. 

What do you enjoy most about working with James E. Fox M.D. PLLC? 

I enjoy the daily challenges. No day is the same at our practice. The constant challenge and change help me 

grow and evolve as a manager. 

Would you rather never sit in traffic again or never wait in line again? Why? 

I would prefer never to wait in line again. At least in the car, I can listen to music and have my quiet time. 

Julie Sheppard on the Importance and Value of 

HCCA Membership 

1st Talk Compliance: Medical Error & Patient 

Advocacy – How Can We Have More Candor? 

Contact Toll Free: 888-54-FIRST 3

FAQ Corner 

Does the HIPAA Privacy Rule prohibit businesses or individuals from asking whether 

their customers or clients have received a COVID-19 vaccine? 

No. The Privacy Rule does not prohibit any person (e.g., an individual or an entity such as a business), 

including HIPAA covered entities and business associates, from asking whether an individual has received 

a particular vaccine, including COVID-19 vaccines. 

First, the Privacy Rule applies only to covered entities (health plans, health care clearinghouses, and 

health care providers that conduct standard electronic transactions) and, to some extent, their business 

associates. 

Second, the Privacy Rule does not regulate the ability of covered entities and business associates to 

request information from patients or visitors. Rather, the Privacy Rule regulates how and when covered 

entities and business associates are permitted to use and disclose protected health information (PHI) 

(e.g., PHI about whether an individual has received a COVID-19 vaccine) that covered entities and business 

associates create, receive, maintain, or transmit. Thus, the Privacy Rule does not prohibit a covered entity 

(e.g., a covered doctor, hospital, or health plan) or business associate from asking whether an individual 

(e.g., a patient or visitor) has received a particular vaccine, including COVID-19 vaccines, although it does 

regulate how and when a covered entity or its business associate may use or disclose information about 

an individual’s vaccination status. 

Additional examples. The Privacy Rule does not apply when an individual: 

• Is asked about their vaccination status by a school, employer, store, restaurant, entertainment venue, 

or another individual. 

• Asks another individual, their doctor, or a service provider whether they are vaccinated. 

• Asks a company, such as a home health agency, whether its workforce members are vaccinated. 

• Other state or federal laws address whether individuals are required to disclose whether they have 

received a vaccine under certain circumstances. 

Please see https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-covid-19-vaccinationworkplace/index.html 

Explore the FAQs tab in your compliance solution 

to find answers to your compliance questions! 

CLIENT 

ALERT 

4 



CIAs, Exclusions, and Your Practice 

Rachel V. Rose, JD, MBA 

Contracting with or employing an excluded 

person can result in a government enforcement 

action. 

Before delving into a recent U.S. Department of Justice 

(DOJ) settlement, which involved employing an “excluded” 

individual, it’s important to appreciate some of the tools 

that the U.S. Department of Health and Human Services 

Office of the Inspector General (HHS-OIG) has at its 

disposal – corporate integrity agreements (CIA) and 

exclusion from all federal programs. 

CIAs – are negotiated by HHS-OIG “with healthcare 

providers and other entities as part of the settlement 

of Federal health care program investigations arising 

under a variety of civil false claims statutes. Providers 

or entities agree to the obligations, and in exchange, OIG 

agrees not to seek their exclusion from participation 

in Medicare, Medicaid, or other Federal health care 

programs.” Typically, a CIA lasts 5 years and the person 

who enters into the CIA must make scheduled reports to 

HHS-OIG. Importantly, CIAs are specific to the facts and 

circumstances of a particular matter and include breach 

and default provisions, which enable HHS-OIG to impose 

additional monetary penalties (i.e., Stipulated Penalties). 

A material breach of the CIA “constitutes an independent 

basis for the provider’s exclusion from participating in 

Federal healthcare programs.” 

Exclusions – have been around since 1977 and are 

imposed by HHS-OIG; however, they may arise because 

of a False Claims Act case or other matter that was 

initiated through or by DOJ. HHS-OIG’s authority to 

impose exclusions is derived from the Social Security 

Act §§ 1128, 1156.“The scope of an exclusion under 

section 1128 of the Act is from all Federal health care 

programs, as defined in 42 CFR 1001.2. … Exclusions 

under section 1156 of the Act do not reach other Federal 

programs (although HHS or another Federal agency 

could separately initiate a suspension or debarment of 

an excluded person from other Federal procurement 

or nonprocurement programs).” The process begins 

when a person receives a Notices of Intent to Exclude 

(NOI). From there, the recipient of the NOI is given the 

opportunity to respond. Once all the information is 

considered, HHS-OIG renders its decision. If the findings 

substantiate exclusion, the person is notified. From 

there, they may appeal to an HHS Administrative Law 

Judge and further appeal to the HHS Departmental 

Appeals Board (DAB). After the DAB renders its decision, 

judicial review in a U.S. District Court is also available. 

Reinstatement of an individual or entity is not automatic; 

rather, the person must apply for reinstatement. If 

reinstated, the person receives written notice from 

HHS-OIG that they have been reinstated. The excluded 

individual may begin the process 90 days before their 

6 


period of exclusion ends. 

On March 18, 2022, the DOJ announced that Windham 

Eye Care Practice and its Owners Pay $192K for 

Employing “Excluded” Individual. Specifically, the federal 

and state governments entered into a civil settlement 

agreement “to resolve allegations that they improperly 

employed an individual who was excluded from all 

federal healthcare programs.” Windham Eye Group (WEG) 

employed Michael Vallone as its practice administrator 

from February 2010 through May 

2021. Previously, Mr. Vallone was 

convicted of healthcare fraud in 

the District of New Jersey and 

was excluded from all federal 

healthcare programs under 

§1128 of the Social Security Act. 

As noted by the DOJ, when 

HHS-OIG “excludes an individual 

or entity from federal health 

care programs, no program 

payments may be made for 

items or services furnished by 

that excluded individual or entity.” 

(emphasis added). The relevance 

to the WEG was that a portion of the reimbursements 

received from the federal healthcare programs were 

used to pay Mr. Vallone’s salary and benefits. 

I have often reiterated the phrase, “an ounce of 

prevention is worth a pound of cure.” HHS-OIG issued 

an Updated Special Advisory Bulletin in May 2013, 

emphasizing that in order to avoid potential liability, 

health care providers and organizations providing 

services directly or indirectly should check the List of 

Excluded Individuals/Entities on the HHS-OIG website. 

It is imperative that entities receiving remuneration 

from Federal health care programs – whether directly 

or indirectly, have both background checks and 

exclusion checks as part of their policies and 

procedures. 

About the Author 

Rachel V. Rose, JD, MBA, advises clients 

on compliance, transactions, government 

administrative actions, and litigation involving 

healthcare, cybersecurity, corporate and 

securities law, as well as False Claims Act 

and Dodd-Frank whistleblower cases. She 

also teaches bioethics at Baylor College of 

Medicine in Houston. Rachel can be reached 

through her website, www.rvrose.com. 

Originally posted on: physicianspractice.com 

COVID-19 Healthcare 

Compliance Updates 

In response to the global outbreak of the novel coronavirus 

disease (COVID-19), the Secretary of Health and Human 

Services declared a public health emergency on January 31, 

2020. Federal agencies have taken action by issuing updates 

and guidance to navigate the crisis. 

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What to know about Operating Clinical 

Laboratories – Nuts and Bolts 

Catherine Short 

Elizabeth Sullivan and Emily Johnson are 

both Members of McDonald Hopkins, a 

business law and advocacy law firm, and 

led the presentation What to Know About 

Operating Clinical Laboratories – Nuts 

and Bolts at the Healthcare Compliance 

Symposium 2022 on April 28, 2022. 

Liz, based in the 

Cleveland office, is 

Chair of McDonald 

Hopkins’ national 

Healthcare Practice 

Group and a member 

of the firm’s Board of 

Directors. She began 

her legal career in the 

Healthcare Practice 

group at McDonald Hopkins and later served as an 

attorney in the legal department at The Cleveland 

Clinic Foundation before returning to McDonald 

Hopkins as a member. 

While at the Cleveland Clinic, Liz provided regulatory 

advice and transactional guidance to various service 

lines, including the clinical laboratory, professional 

pathology, imaging, transplant, and remote and 

distance health teams. Over the course of her 

career, Liz has assisted various types of healthcare 

providers, including clinical laboratories, hospitals, 

physician specialty groups, telehealth providers, 

transplant centers, and surgery centers. 

Liz has experience providing regulatory, licensing, 

compliance, reimbursement, contractual, and 

corporate guidance to clients. She has advised 

clients on state professional licensure laws, CLIA 

standards, state laboratory laws, government and 

private payor reimbursement policies and billing 

rules, federal and state fraud and abuse rules and 

regulations, state telehealth laws, and HIPAA rules 

and regulations. She has provided assistance to 

entities during licensure and accreditation surveys, 

government investigations, and through payor audits 

and disputes. 

In addition to providing regulatory guidance to 

clients, Liz is also knowledgeable in evaluating how 

a business opportunity or arrangement implicates 

a provider’s unique regulatory framework. Liz has 

counseled clients not only on the regulatory aspects 

of an arrangement as described above, but she 

is also experienced in reviewing and negotiating 

8 


elevant contractual and legal documentation 

in connection with contemplated business 

arrangements. 

Liz earned a J.D. and Certificate of Advanced Studies 

in Health Law from the University of Pittsburgh 

School of Law, an M.A. in Bioethics and a B.A., 

cum laude, in Political Science from Case Western 

Reserve University. 

Emily Johnson, based in the Chicago office, focuses 

her practice on matters primarily for clients in the 

healthcare industry. 

She provides 

regulatory and 

compliance assistance 

on both a federal 

and state level. She 

has assisted clinical 

laboratories, hospitals, 

long-term acute 

care hospitals, community hospitals, physician 

specialty groups, telehealth providers, surgery 

centers, healthcare associations, pharmacies, and 

other healthcare providers on regulatory, licensing, 

compliance, reimbursement, contractual, and 

corporate matters. She has provided support to 

entities during licensure and accreditation surveys 

and assisted in navigating state professional 

licensure laws, CLIA standards and state and federal 

laboratory laws and regulations, government and 

private payor reimbursement, state and federal fraud 

and abuse rules, state telehealth laws, and state and 

federal pharmacy regulation. She also has advised 

clients on direct to consumer testing issues and 

applicable state requirements. 

She also has experience with provider-based 

compliance issues and the 340B Federal Drug 

Pricing Program, including implementation, program 

compliance, audit preparation, and preparing for 

audits conducted by the Office of Pharmacy Affairs. 

In addition, she has significant experience with 

HIPAA compliance, including drafting HIPAA policies 

and procedures, breach response and notification, 

drafting responses to investigations conducted by 

the Office for Civil Rights, and advising clients on 

proactive HIPAA compliance and breach prevention. 

Prior to joining McDonald Hopkins, Emily served as 

healthcare attorney/senior consultant at a national 

legal-based healthcare management consulting firm 

and outside counsel to the National Association of 

Navigating Workplace Violence 

Prevention Under OSHA 

Workplace violence is a serious issue, especially in healthcare 

facilities. The Occupational Safety and Health Administration 

(OSHA) responded in 2015 by updating and publishing their 

guidelines on how to best prevent workplace violence. 

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Revenue Cycle and Compliance Summit 2022 


Revenue Cycle Coding Strategies 

and First Healthcare Compliance 

Offer Revenue Cycle and Compliance 

Summit with Expert Speakers on June 

23, 2022 

Revenue Cycle Coding Strategies (RCCS) and First 

Healthcare Compliance to provide resources for 

professionals facing the challenges of auditing, 

billing, and coding compliance. The virtual half-day 

online educational event will be held on June 23, 

2022, from 12:00p.m. EST until 4:30 p.m. EST and 

registration is open to the public. 

“During this time of continuous change, quality 

education about compliance related to the revenue 

cycle is imperative”, states Julie Sheppard, Founder 

and President of First Healthcare Compliance. 

Sheppard continues, “we rely on RCCS as a trusted 

resource for our clients.” Melody W. Mulaik, President 

of RCCS is a nationally recognized expert and the 

First Healthcare Compliance 2021 presenter of the 

year. 

Four learning modules will be offered with 

opportunities for learning credits. Attendees are 

eligible to receive 4 CLE in Pennsylvania. This 

program has been approved for 4 continuing 

education unit(s) by PAHCOM and Practice 

Management Institute®. 

The agenda for the educational workshop 

in EST: 

12:00 p.m.-12:15 p.m. Virtual Waiting Room and 

Welcome 

12:15 p.m. – 1:15 p.m. Michael Denbow, Esq. 

Responding to and Defending Government 

Investigations: What to do When the Government 

“Knocks” On Your Door 

1:15 p.m. -1:20 p.m. Break 

1:20 p.m.- 2:20 p.m. Melody W. Mulaik 1,2,3’s of 

Auditing: How to Ensure Ongoing Proactive Coding 

& Documentation Audits for Reimbursement and 

Compliance 

10 


2:20 p.m. -2:25 p.m. Break 

2:25 p.m. -3:25 p.m. Sara Spurlock, Esq. Under 

Attack: Ransomware Threats, Prevention Tips, and 

Response Strategy for Health Care Providers 

3:25 p.m. -3:30 p.m. Break 

3:30 p.m.-4:30 p.m. Melody W. Mulaik The “Other” 

Compliance Challenges: Credentialing, Credit Balance, 

Appropriate Use Criteria (AUC) and More! 

About Revenue Cycle Coding Strategies: Revenue 

Cycle Coding Strategies is a trusted partner of 

private practices, healthcare systems, hospitals, 

and other industry stakeholders, providing solutions 

for challenges in all aspects of the charge capture 

process. For more information, please visit https:// 

rccsinc.com/ 

Register now for this virtual event. 

Referral Appreciation Program 

Receive a $50 gift card* when you refer a client! 

First Healthcare Compliance is delighted to offer 

a Referral Appreciation Program to say thank you 

for helping us to continue to grow. For each new 

1st Professional or 1st Premium client originating 

from a referral, First Healthcare Compliance will 

provide a $50 gift card as a token of appreciation. 

LEARN MORE 


Let’s Talk About Sex, 

Baby: Common Mistakes 

and Pitfalls When 

Addressing Sex and 

Pregnancy Discrimination 

in the Workplace 


Lauren Moak Russell, Counsel at 

Young Conaway Stargatt & Taylor, LLP 

will led the presentation Let’s Talk 

About Sex, Baby: Common Mistakes 

and Pitfalls When Addressing Sex 

and Pregnancy Discrimination in 

the Workplace at the Healthcare 

Compliance Symposium 2022 on April 

28, 2022. 

Lauren specializes in the representation of employers 

on a range of issues relating to compliance with 

local, state, and federal labor and employment 

laws and constitutional provisions. She provides 

compassionate and responsive counsel, targeted at 

achieving client goals while minimizing cost and risk. 

Lauren emphasizes client counseling—on issues 

ranging from wage and hour compliance, to 

workplace training and investigations, to effective 

employee terminations—with the goal of avoiding 

litigation before it begins. Her counseling practice 

includes handbook revisions, effective policy 

implementation, and on-site training on legal 

compliance. 

Lauren has developed 

and conducts 

specialized in-house 

training for emerging 

legal issues including 

the pregnancy, 

reproductive 

rights, and family 

care provisions of the Delaware Discrimination in 

Employment Act. One of her current programs 

outlines the complexities of the #MeToo movement 

and offers executives essential information on 

harassment avoidance and modifying corporate 

culture. Lauren also conducts high-level 

investigations of discrimination and harassment on 

behalf of employers. 

When litigation becomes necessary, Lauren is a 

dedicated advocate, aggressively pursuing her clients’ 

best interests and providing clear guidance at each 

12 


stage of the proceeding. Lauren has litigated a wide 

variety of employment-related matters to successful 

resolutions, including employment discrimination, 

non-competition, and constitutional law cases. 

Lauren has experience in each of Delaware’s state 

and federal courts, as well as the U.S. Court of 

Appeals for the Third Circuit. Lauren also regularly 

assists clients in administrative proceedings before 

state and federal administrative agencies, including 

the EEOC, the Delaware Office of Anti-Discrimination, 

and the Delaware Unemployment Insurance Appeals 

Board. 

C. Trey Scott, Healthcare Coordinating compliance Attorney at amidst COVID-19 presents new challenges 

Kennedy, Attorneys for hospitals & Counselors and healthcare at Law providers. At top importance is the 

will present Under question Pressure: of how Reporting to slow or stop the spread of COVID-19, while 

Appeals for the Fifth Circuit. 

Requirements with OCR ensuring for Breaches that your at the organization stays compliant. 

upcoming Virtual HIPAA Privacy and Security 

Summit 2021 on Now November more than 18. ever, your compliance Summit! department needs to have the 

necessary tools to help track, analyze, and respond to compliance challenges. 

Trey received his To Bachelor help navigate of Science the and process, Master of we’ve gathered our best COVID-19 resources 

Business degrees from Texas below. Tech If University you need and further his assistance, please contact us here. 

Juris Doctorate from Texas Wesleyan University School 

of Law (now Texas A&M University School of Law.) While 

in law school, Trey was a member of the arbitration 

competition team as well as a student bar association 

representative. He also was a law clerk to the 106th 

District Court of the State of Texas. Trey has significant 

experience in healthcare law. This experience includes: 

medical malpractice litigation, administrative and 

regulatory appeals and disputes, professional board 

matters, and overpayment disputes. Trey is licensed to 

practice law before Texas State Courts as well as the 

COVID-19 Healthcare 

Compliance Toolkit 

VIEW TOOLKIT 

United States District Courts for the Northern, Southern, 

Eastern, and Western Districts of Texas. Trey is also 

licensed to practice before the United States Court of 

Click here for more information or to register for the 


Julie Sheppard on the Importance and 

Value of HCCA Membership [Podcast] 

Adam Turteltaub 

If you have ever considered joining the 

Health Care Compliance Association 

(HCCA) but haven’t, this podcast will 

give you cause to reconsider. 

Julie Sheppard, Founder and President of First 

Healthcare Compliance joined the association a 

decade ago when she was looking for a reliable 

source of information on healthcare compliance 

issues. She wanted an unbiased, trusted source 

of information that would keep her updated on the 

challenges of managing compliance. 

range of HCCA programs, from an Academy to web 

conferences to reading the magazine Compliance 

Today. 

She also obtained her Certified in Healthcare 

Compliance (CHC) designation, which she sees as a 

means to differentiate herself and demonstrate her 

expertise. 

Listen in to learn more about her journey with HCCA 

and how she sees healthcare compliance evolving 

over the next few years. 

Through the years she has taken advantage of a wide 

Listen Now 

14 


Revenue Cycle and 

Compliance Summit 

June 23, 2022 

REGISTER NOW 

Risk Management Considerations for 

the Healthcare Compliance Officer: 

Training, Incident Management, Governing Boards, 

and Measures Unique to COVID-19 

It’s no secret that healthcare is one of America’s 

most heavily regulated industries with 

substantial fines and penalties for noncompliance. 

Complex regulations and mandates 

make compliance management a necessity. 

Healthcare organizations particularly rely on the 

skills and attributes of their compliance officer 

to navigate the expansive regulatory framework. 

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hosted by Catherine Short 

1st Talk Compliance features guest Kathleen W. McNicholas, MD, JD, CHC, CCEP, Consultant and Patient 

Advocate with Medical Legal Patient Advocacy Inc., on the topic of “Medical Error & Patient Advocacy – 

How Can We Have More Candor?” Kathleen joins our host, Catherine Short to review medical error and 

provide an approach to harmed patients. The CANDOR program of Communication and Optimal Resolution 

will be explained. CANDOR is well established and has been successfully adopted by many medical centers. 

Without CANDOR in place, patients may benefit from the use of the principles and the help of a board-certified 

patient advocate. 

Listen weekdays at 

7:30am, 3:30pm, 11:30pm ET 

Check out our Show Page! 

Looking for the latest compliance insights? 

Subscribe to our feed and don’t miss a thing! 

16 


WORD SEARCH 

N I N O M D K A Y B Y A V U F M E A E H 

V R F G Y D G Y T I R U C E S R E B Y C 

X E P N K Q G N M N N P Q Y S F H L Z O 

I V A E N O I T A N I M I R C S I D O M 

I E T L X H C N X P J N F C E G W F B P 

C N V T S A C D O P F X O I B M L W H L 

C U N L A R E D E F Y Y R V N H E P X I 

S E I F F L Z R S F L O J F O M P C V A 

Q O Q D C H I D E Q T Y U N I C I E P N 

Z C B G J G K S P A L S B O T Y Y B E C 

H E A L T H C A R E A I L I A U E R L E 

F H R P A D V O C A C Y V S C E O K K I 

T H G C K B B H R C I H J U I V Q D E D 

R Q E T E A Y N O P D S W L N O Y W X G 

C U G S L X J T P E E Z I C U R A R M F 

Z N N F A M R W T M M X C X M I Q Y H G 

N Q I P L Y Z G F N E I S E M X Y X H L 

M B D D T C R E S O L U T I O N O P K N 

P Y O B S L F C Y E N F O R C E M E N T 

Y F C T W A C R N R I L M T B I J F H Z 

RESOLUTION MEDICAL ADVOCACY 

ENFORCEMENT EXCLUSION FEDERAL 

CYBERSECURITY LABORATORIES CODING 

COMPLIANCE REVENUE HEALTHCARE 

DISCRIMINATION PODCAST COMMUNICATION 


Upcoming and On-Demand Webinars 

Training 

July 12, 2022 

ON DEMAND 

ON DEMAND 

ON DEMAND 

Workplace Civility: What Non-Unionized Employers Need 

to Know to Navigate the NLRA 

How to Prevent Employee Snooping and Insider Threats 

DMEPOS - CMS Compliance and Requirements Updates 

Under Pressure: Reporting Requirements with OCR for 

Breaches 

Register 

All Upcoming Webinars 

All On Demand Webinars 

IMPORTANT 

In the interest of your security, login credentials are 

for individual use only and not to be shared. Please 

contact Client Services if you require additional 

manager level users and/or if there has been a 

change in contact information. 

NEW FEATURES! 

Employee Zone/Compliance Detail 

Initial Data - Free text comment field has been 

added. 

COVID Vaccination Status - 

Additional fields have been added for 

Second Booster 

COVID Vaccination Status/ COVID 

Testing - Additional fields have been 

added to assist you with tracking COVID vaccination 

and COVID Testing. Contact Client Services if you have 

any questions or would like to turn COVID alerting off. 

Training Zone - Employee Activated Status has been 

added to the Training Zone landing page view. 

CLIENT 

ALERT 

Join us on Social Media! 

Contact our Client Services Team with your questions! 

888.54.FIRST or clientservices@1sthcc.com 

18

First Healthcare Compliance CONNECT May 2022

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