dcsimg Healthcare Regulation and Policy

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

Stephanie A. Kennan Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC T: +1 202 857 2922
Results 1-19 of 19

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.
Representative Matter

Client

Successfully prompted FDA to issue a Warning Letter based on submission of evidence that a competitor was making false and off-label promotional claims, resulting in diminution of competitor's stock value and providing a foundation for significant litigation to recoup damages.
Representative Matter

Lenders and investors

Represent lenders and investors in transactions with life science companies, performing high view and deep dive FDA due diligence to assess risks, benefits, and the need for fortified specialty agreements in such deals.
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 nationwide wireless provider

Outside FDA regulatory counsel for a major nationwide wireless provider at the forefront of mobile health innovation, advocating for industry at FDA to bring the effectiveness and savings of mHealth to the U.S. market.
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

Pharmaceutical company

Effectively prompted FDA to issue a Warning Letter based on submission of evidence that a competitor was making false and off-label promotional claims, resulting in diminution of competitor's stock value and providing a foundation for significant litigation to recoup damages.
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 compliance and internal audit issues.
Representative Matter

Various hospitals and surgery centers

Advised many hospitals and surgery centers regarding hospital-physician contracts.
Results 1-19 of 19
Results 1-25 of 32
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Frank B Atkinson Frank B. Atkinson
Partner
One James Center
901 East Cary Street
Richmond, VA 23219-4030

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

T: +1 312 849 8123
F: +1 312 698 4538
vCard
Evan Bayh Evan Bayh
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

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

T: +1 312 849 8222
F: +1 312 698 4571
vCard
Meggan Michelle Bushee Meggan Michelle Bushee
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

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

T: +1 312 849 3687
F: +1 312 698 4504
vCard
Vincent A Dongarra Vincent A. Dongarra
Associate
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1049
F: +1 804 225 5404
vCard
Scott P Downing Scott P. Downing
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8910
F: +1 312 920 6126
vCard
Amanda L Enyeart Amanda L. Enyeart
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8106
F: +1 312 698 4523
vCard
Franklin E Freeman Jr. Franklin E. Freeman Jr.
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

T: +1 919 836 4003
F: +1 919 755 6699
vCard
Timothy Fry Timothy J. Fry
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8659
F: +1 312 849 3690
vCard
Jason S Greis Jason S. Greis
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8217
F: +1 312 698 4550
vCard
D. Bowen Heath D. Bowen Heath
Counsel
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

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

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

T: +1 919 836 4001
F: +1 919 836 4031
vCard
Jennifer Koltse Jennifer Russano Koltse
Counsel
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8228
F: +1 312 698 4512
vCard
Nathan A Kottkamp Nathan A. Kottkamp
Partner
One James Center
901 East Cary Street
Richmond, VA 23219-4030

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

T: +1 704 373 8997
F: +1 704 444 8806
vCard
Thomas Londrigan Thomas F. Londrigan Jr.
Partner
1 Old State Capitol Plaza
Suite 410
Springfield, IL 62701

T: +1 217 527 1281
F: +1 217 527 1290
vCard
Leigh B Middleditch Jr. Leigh B. Middleditch Jr.
Counsel
Court Square Building
310 Fourth Street, N.E.
Suite 300
Charlottesville, VA 22902-1288

T: +1 434 977 2543
F: +1 434 980 2267
vCard
Elissa K Moore Elissa K. Moore
Counsel
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2218
F: +1 704 353 6164
vCard
David J Pivnick David J. Pivnick
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 3585
F: +1 312 698 4539
vCard
Robert J Pristave Robert J. Pristave
Counsel
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8616
F: +1 312 558 4376
vCard
Michael P Reynold Michael P. Reynold
Counsel
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1917
F: +1 804 775 1061
vCard
James B Riley Jr. James B. Riley Jr.
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 8665
F: +1 312 920 6133
vCard
Results 1-20 of 22
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Event

Healthcare Regulatory and Compliance Issues

Financial Relationships Between Healthcare Providers and Physicians

April 16, 2014
McGuireWoods LLP Audio Conference Series
Event

8 Key Trends in Healthcare False Claims and Antitrust Litigation

March 12, 2014
Complimentary Teleconference
Event

Healthcare Regulatory and Compliance Issues

Financial Relationships Between Healthcare Providers and Physicians

March 10, 2014
McGuireWoods LLP Audio Conference Series
Event

The Final Regulations Under the ACA Employer Health Coverage Mandate

February 26, 2014
Complimentary Webinar
Event

10 Key Points Providers Should Know for 2014 HIPAA Compliance

January 16, 2014
Complimentary Webinar
Event

Deficits, Debt and Deductions

Will You Be at the Table or on the Menu for the Tax Reform Debate?

September - December 2013
McGuireWoods Offices
Speaking Engagement

Focus on HIPAA Compliance

Meeting the September HITECH Omnibus Rule Compliance Deadline

July 31, 2013
Thomson Reuters Webcast
Speaking Engagement

Benefits Law and Regulation: What More is Coming in 2013?

May 2, 2013
Bloomberg BNA Webinar
Event

Are You Still HIPAA Compliant?

Staying Protected in the Wake of the Omnibus Final Rule

March 27, 2013
HIPAA and the HITECH Final Rule Webinar Series
Event

Ambulatory Surgical Center Trends

Sales, Joint Ventures, Specialties, Turnarounds and Other Key Issues

March 21, 2013
Complimentary Teleconference
Event

Are You Still HIPAA Compliant?

Staying Protected in the Wake of the Omnibus Final Rule

March 19, 2013
HIPAA and the HITECH Final Rule Webinar Series
Event

Seven Emerging Issues in Stark, Kickback and False Claims Cases

March 6, 2013
Complimentary Webinar
Event

Investing in Urgent Care

Key Business and Legal Considerations

November 14, 2012
Complimentary Webinar
Results 1-20 of 22
Results 1-20 of 140
Show All
Legal Alert

Highlights from the 2015 OIG Work Plan

November 6, 2014
Legal Alert

New Regulations Issued for Dental, Vision, Long-Term Care and EAPs as Excepted Benefits under Healthcare Reform

McGuireWoods Healthcare Reform Guide: Installment No. 45

October 14, 2014
Publication

9 Core Considerations for Boards of Directors Considering a Hospital or Health System Affiliation

2014
Holly Carnell, Healthcare Insights, KeyBank Capital Markets and McGuireWoods LLP
Legal Alert

Circuit Courts Clash over Tax Subsidies for Health Insurance Purchased on Federally-Run Exchanges

McGuireWoods Healthcare Reform Guide: Installment No. 44

July 30, 2014
Article

Counsel's Role in Evaluation and Negotitating D&O Insurance Coverage

Hospitals & Health Systems Rx
May 2014
Stephen David Allred, Kathleen H. Dooley, A Publication of the American Health Lawyers Association Hospitals and Health Systems Practice Group
Legal Alert

EU Medical Device Rules

New Rules Are Nearly There But Not Quite

FDA Life
May 15, 2014
Legal Alert

Key Changes in CMS’ New ESCO Rules

May 9, 2014
Legal Alert

All HIEs Are Not Created Equal

Privacy and Security Considerations Related to HIE Participation

May 6, 2014
Legal Alert

ICD-10 Deadline Delayed until Oct. 1, 2015

April 4, 2014
Results 1-20 of 140