Healthcare Regulation and Policy

Government oversight affects every aspect of the healthcare industry, from construction of new healthcare facilities to payment for medical services. With multiple regulatory bodies governing healthcare at both the state and federal levels — often with overlapping authority — providers and insurers are left to juggle numerous, constantly changing regulations and policies.

The healthcare attorneys at McGuireWoods have the knowledge and experience that healthcare providers and insurers need to achieve compliance with federal and state-specific regulatory requirements. Our group of more than 60 healthcare-focused attorneys advises clients on a full range of regulatory and policy issues, including:

  • Federal and state anti-kickback and fraud and abuse laws
  • Federal and state self-referral laws, including the federal Stark law
  • Restrictions on patient transfers, including the federal Emergency Medical Treatment and Active Labor Act (EMTALA)
  • Health Care Quality Improvement Act
  • Patient consent issues
  • Death and end-of-life issues
  • Corporate practice of medicine restrictions
  • Medicare and Medicaid conditions of participation
  • Federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA)
  • False Claims Act
  • Food and Drug Administration (FDA) regulations
  • Employee Retirement Income Security Act (ERISA)
  • U.S. healthcare reform, including the Patient Protection and Affordable Care Act (PPACA)

We take full advantage of our firm’s national network of offices to represent clients in local, state and federal regulatory matters in jurisdictions throughout the United States. Given the rate of change and level of uncertainty in this highly regulated industry, we update our clients regularly on both national and local trends and pending legislation. We provide updates via frequent client alerts, help newsletters and blogs, including The Healthcare Investor.

CONTACTS

Kimberly J. Kannensohn Partner T: +1 312 750 8649 Email
Stephanie A. Kennan Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC T: +1 202 857 2922 Email
Results 1-15 of 15

RESULTS DEPEND ON A VARIETY OF FACTORS UNIQUE TO EACH CASE. PRIOR RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR OUTCOME.

Representative Matter

Research and education foundation

Assisted research and education foundation in securing a multimillion-dollar, multi-year grant from a medical device manufacturer to support clinical spine research and in developing a broader program to ensure industry compliance with the fraud and abuse laws in grant making.
Representative Matter

Various clients

Assisted various clients in assessing the HIPAA and HITECH issues raised by the provision of mHealth services and in developing contractual and operational approaches to compliance.
Case Study

McGuireWoods' Atlanta office assists client with certificate of need for home health

McGuireWoods recently assisted Duluth Medical Home Health with obtaining a Certificate of Need for a new home health agency dedicated to the Asian population. The State of Georgia recognized an exception under the general rules and criteria in granting the certificate.

Case Study

McGuireWoods secures certificate of need approval for Three Rivers Home Health-Treutlen

Three Rivers Home Health Services-Treutlen received certificate of need approval from the Georgia Department of Community Health, Division of Health Planning on March 24, 2009. With this approval, Three Rivers will be able to expand its home health service area to include nine additional counties in south Georgia. McGuireWoods partner Victor Moldovan and counsel Shay Bowen (both Health Care, Atlanta) represented Three Rivers in this victory.

Representative Matter

Client

Assess the application of HIPAA, the HITECH Act and the FTC breach notification rule to various telephony based products and services, including remote disease management, telephone answering services, medical paging services and personal emergency response services.
Representative Matter

Client

Regularly counsel clients regarding Medicare and Medicaid Anti-Kickback issues, Medicare coverage and payment issues, and HIPAA issues raised by the storage, receipt or transmission of patient health information.
Representative Matter

Client

Assist clients with the implementation of HIPAA compliance programs, including preparing compliance plan documents, conducting training and assisting in the establishment of an infrastructure for monitoring and reporting.
Representative Matter

Healthcare providers, health plans, business associates and business associate subcontractors

Prepare and negotiate business associate agreements and business associate subcontracts for healthcare providers, health plans, business associates and business associate subcontractors.
Representative Matter

Hospitals and surgery centers

Represented hospitals and surgery centers across the county in medical staff investigations, disciplinary matters, and hearings and in preparation of, and revisions to, medical staff bylaws.
Representative Matter

Major drug manufacturer

Assisted major drug manufacturer in negotiating with FDA, avoiding substantial product recall.
Representative Matter

Major university

Advised major university in certificate of need approval, development, and operation of $135 million proton therapy institute.
Representative Matter

New Virginia-based hospital

Provided Virginia certificate of public need advice for numerous projects over 24 years, including development of new $166 million, 126-bed new hospital.
Representative Matter

Telecommunications company

Counseled on HIPAA security compliance, and drafted and revised security policies.
Representative Matter

Various hospitals and surgery centers

Advised many hospitals and surgery centers regarding hospital-physician contracts.
Representative Matter

Various hospitals and surgery centers

Advised many hospitals and surgery centers regarding compliance and internal audit issues.
Results 1-15 of 15
Results 1-25 of 39
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Frank B Atkinson Frank B. Atkinson
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 4376
F: +1 804 698 2226
vCard
Brett Barnett Brett W. Barnett
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8123
F: +1 312 698 4589
vCard
Evan Bayh Evan Bayh
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040
Email
T: +1 202 828 2825
F: +1 202 828 3331
vCard
Samuel C Bernstein Samuel C. Bernstein
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8222
F: +1 312 698 4571
vCard
Hilary Blackwood Hilary S. Blackwood
Attorney
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 373 8850
F: +1 704 373 8827
vCard
Amy Bolian Amy Elizabeth Bolian
Associate
1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215
Email
T: +1 703 712 5017
F: +1 703 712 5193
vCard
Meggan Michelle Bushee Meggan Michelle Bushee
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2360
F: +1 704 805 5085
vCard
Holly Carnell Holly Carnell
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 3687
F: +1 312 698 4504
vCard
Anthony M. Del Rio
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8166
F: +1 312 558 4380
vCard
Paige J Dowdakin
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8258
F: +1 312 698 4564
vCard
Scott P Downing Scott P. Downing
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 750 8910
F: +1 312 920 6126
vCard
Franklin E Freeman Jr. Franklin E. Freeman Jr.
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601
Email
T: +1 919 836 4003
F: +1 919 755 6584
vCard
Timothy Fry Timothy J. Fry
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 750 8659
F: +1 312 698 4596
vCard
Jason S Greis Jason S. Greis
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8217
F: +1 312 698 4550
vCard
Kate Hardey Kate Waters Hardey
Partner
1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215
Email
T: +1 703 712 5337
F: +1 703 712 5192
vCard
John Haring John P. Harig
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8167
F: +1 312 558 4378
vCard
Bo Heath D. Bowen Heath
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601
Email
T: +1 919 836 4009
F: +1 919 755 6699
vCard
Kimberly J Kannensohn Kimberly J. Kannensohn
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 750 8649
F: +1 312 920 3683
vCard
Harrison J Kaplan Harrison J. Kaplan
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601
Email
T: +1 919 836 4001
F: +1 919 836 4031
vCard
Paul A. Kiehl
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 4702
F: +1 804 698 2062
vCard
Nathan A Kottkamp Nathan A. Kottkamp
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1092
F: +1 804 698 2072
vCard
LauraLee R Lawley LauraLee R. Lawley
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 373 8997
F: +1 704 444 8806
vCard
Jamie Elizabeth Levin
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 641 2742
F: +1 312 920 6142
vCard
Thomas Londrigan Thomas F. Londrigan Jr.
Partner
1 North Old State Capitol Plaza
Suite 410
Springfield, IL 62701
Email
T: +1 217 527 1281
F: +1 217 527 1290
vCard
Kayla Marty Kayla McCann Marty
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2352
F: +1 704 343 2300
vCard
Results 1-20 of 48
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Event

11th Annual Healthcare Provider Conference

Healthcare Finance and Growth

Tuesday, October 11, 2016
Charlotte, NC
Event

HIPAA Hot Topics

An Examination of Recent Developments and Enforcement Actions

Thursday, August 11, 2016
Complimentary Webinar
Speaking Engagement

Dental Practice Mergers, Acquisitions, Divestitures and Affiliations

March 31, 2016
Live Webinar
Event

HIPAA Webinar Series

March 30 & April 6, 2016
Complimentary Healthcare Webinars
Speaking Engagement

ABA Techshow 2016

Getting HIP to HIPAA

March 16-19, 2016
Chicago, IL
Event

Key Issues Facing Urgent Care Providers

January 28, 2016
Complimentary Webinar
Event

17 Winners and Losers Under the Affordable Care Act

December 15, 2015
Complimentary Teleconference
Speaking Engagement

PHA Executive Summit

September 30 - October 2, 2015
Napa, CA
Event

10th Annual Healthcare Provider Conference

Healthcare Finance and Growth

September 17, 2015
Charlotte, NC
Event

Dental Practice Transactions and Regulatory Update

September 2, 2015
Complimentary Webinar
Speaking Engagement

Becker's Hospital Review Annual CIO/HIT + Revenue Cycle Summit

July 21, 2015
Chicago, IL
Speaking Engagement

State Rural Health Association Leadership Conference

July 14, 2015
Minneapolis, MN
Event

10 Key Anti-Kickback and Stark Act Issues in 2015

May 21, 2015
Complimentary Teleconference
Speaking Engagement

National Urgent Care Convention

Planning. Adapting. Succeeding: New Strategies for Changing Times

April 30, 2015
Chicago, IL
Results 1-20 of 48
Results 1-20 of 179
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Legal Alert

OCR Makes It Official: Ransomware Attacks Are HIPAA Breaches

Password Protected
July 26, 2016
Legal Alert

Can the ACA Employer Health-Insurance Mandate Be Avoided by Reducing Employees’ Hours?

McGuireWoods Healthcare Reform Guide: Installment No. 56

April 21, 2016
Legal Alert

FTC Releases Mobile Health Apps Interactive Tool

Password Protected
April 12, 2016
Legal Alert

HIPAA Breach Reporting Deadline: February 29

February 18, 2016
Legal Alert

IRS Announces Affordable Care Act Reporting Extensions

McGuireWoods Healthcare Reform Guide: Installment No. 55

December 30, 2015
Legal Alert

Highlights from the 2016 OIG Work Plan

December 9, 2015
Legal Alert

New FAQs on Preventive Services, Wellness Program Rewards and Mental Health and Substance Use Treatment

McGuireWoods Healthcare Reform Guide: Installment No. 54

November 4, 2015
Results 1-20 of 179