Healthcare Regulation and Policy

CONTACTS

Kimberly J. Kannensohn Partner T: +1 312 750 8649 kkannensohn@mcguirewoods.com

Melissa Gilmore Senior Counsel T: +1 202 857 1724 mgilmore@mcguirewoods.com

Stephanie A. Kennan Sr. VP, Federal Public Affairs
McGuireWoods Consulting LLC T: +1 202 857 2922 skennan@mwcllc.com

Search Results

Results 1-20 of 20

Representative Matter

Research and education foundation

Assisted research and education foundation in securing a multi-million 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

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

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

Major drug manufacturer

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

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

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

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

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

Major nationwide wireless provider

Representative Matter

Major university

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

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.

Representative Matter

Telecommunications company

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

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

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.

Results 1-20 of 20

Keyword Search

Practice: Healthcare Regulation and Policy

Industry

International

Asset Types

All Experience Types
Case Studies
Representative Matters

Search Results

Results 1-25 of 33

Show All

Filter By Last Name:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Frank B. Atkinson Partner	One James Center 901 East Cary Street Richmond, VA 23219-4030	fatkinson@mcguirewoods.com T: +1 804 775 4376 F: +1 804 698 2226 vCard
Samuel C. Bernstein Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	sbernstein@mcguirewoods.com T: +1 312 849 8222 F: +1 312 698 4571 vCard
Meggan Michelle Bushee Associate	201 North Tryon Street Suite 3000 Charlotte, NC 28202-2146	mbushee@mcguirewoods.com T: +1 704 343 2360 F: +1 704 805 5085 vCard
Holly Carnell Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	hcarnell@mcguirewoods.com T: +1 312 849 3687 F: +1 312 698 4504 vCard
Vincent A. Dongarra Associate	One James Center 901 East Cary Street Richmond, VA 23219-4030	vdongarra@mcguirewoods.com T: +1 804 775 1049 F: +1 804 225 5404 vCard
Scott P. Downing Partner	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	sdowning@mcguirewoods.com T: +1 312 750 8910 F: +1 312 920 6126 vCard
Amanda L. Enyeart Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	aenyeart@mcguirewoods.com T: +1 312 849 8106 F: +1 312 698 4523 vCard
Franklin E. Freeman Jr. Partner	434 Fayetteville Street Suite 2600 Raleigh, NC 27601	ffreeman@mcguirewoods.com T: +1 919 836 4003 F: +1 919 755 6699 vCard
Melissa Gilmore Senior Counsel	2001 K Street N.W. Suite 400 Washington, DC 20006-1040	mgilmore@mcguirewoods.com T: +1 202 857 1724 F: +1 202 828 3302 vCard
Jason S. Greis Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	jgreis@mcguirewoods.com T: +1 312 849 8217 F: +1 312 698 4550 vCard
D. Bowen Heath Counsel	434 Fayetteville Street Suite 2600 Raleigh, NC 27601	dbheath@mcguirewoods.com T: +1 919 836 4009 F: +1 919 755 6699 vCard
Kimberly J. Kannensohn Partner	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	kkannensohn@mcguirewoods.com T: +1 312 750 8649 F: +1 312 920 3683 vCard
Harrison J. Kaplan Partner	434 Fayetteville Street Suite 2600 Raleigh, NC 27601	hkaplan@mcguirewoods.com T: +1 919 836 4001 F: +1 919 836 4031 vCard
Christian Michael Kennedy Partner	434 Fayetteville Street Suite 2600 Raleigh, NC 27601	ckennedy@mcguirewoods.com T: +1 919 755 6673 F: +1 919 755 6598 vCard
Payal Keshvani Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	pkeshvani@mcguirewoods.com T: +1 312 750 3616 F: +1 312 698 4558 vCard
Nathan A. Kottkamp Partner	One James Center 901 East Cary Street Richmond, VA 23219-4030	nkottkamp@mcguirewoods.com T: +1 804 775 1092 F: +1 804 698 2072 vCard
LauraLee R. Lawley Associate	201 North Tryon Street Suite 3000 Charlotte, NC 28202-2146	llawley@mcguirewoods.com T: +1 704 373 8997 F: +1 704 343 2300 vCard
Thomas F. Londrigan Jr. Partner	1 Old State Capital Plaza Suite 410 Springfield, IL 62701	tlondrigan@mcguirewoods.com T: +1 217 527 1281 F: +1 217 527 1290 vCard
Drew E. McCormick Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	dmccormick@mcguirewoods.com T: +1 312 641 2084 F: +1 312 698 4501 vCard
Leigh B. Middleditch Jr. Counsel	Court Square Building 310 Fourth Street, N.E. Suite 300 Charlottesville, VA 22902-1288	lmiddleditch@mcguirewoods.com T: +1 434 977 2543 F: +1 434 980 2267 vCard
Alison Vratil Mikula Counsel	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	amikula@mcguirewoods.com T: +1 312 750 8911 F: +1 312 698 4573 vCard
Elissa K. Moore Counsel	201 North Tryon Street Suite 3000 Charlotte, NC 28202-2146	emoore@mcguirewoods.com T: +1 704 343 2218 F: +1 704 353 6164 vCard
David J. Pivnick Associate	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	dpivnick@mcguirewoods.com T: +1 312 750 3585 F: +1 312 698 4539 vCard
Robert J. Pristave Counsel	77 West Wacker Drive Suite 4100 Chicago, IL 60601-1818	rpristave@mcguirewoods.com T: +1 312 750 8616 F: +1 312 558 4376 vCard
Michael P. Reynold Counsel	One James Center 901 East Cary Street Richmond, VA 23219-4030	mreynold@mcguirewoods.com T: +1 804 775 1917 F: +1 804 775 1061 vCard