Practice Areas & Industries: Carlton Fields, P.A.

Practice/Industry Group Overview

The health care industry has undergone radical changes and continues to undergo dynamic changes, caused heavily by technology, competition, and especially government regulation. Regulatory compliance alone has created rigid (and ever-increasing) guidelines in all areas of health care, particularly hospital, clinic, and nursing home operations. At the same time, the consolidation of the industry, primarily through mergers and acquisitions, has increased the business and legal complexity of the industry tenfold.

Carlton Fields lawyers have kept pace with and anticipated these changes, keeping our clients both compliant and competitive. The Health Care Practice Group at Carlton Fields is comprised of a broad-based team of experienced health law attorneys who assist our health care clients in a wide variety of areas. Attorneys who practice in this group are actively involved in representing virtually every type of health care industry with their compliance, regulatory, and litigation needs. We cover the entire health care field including providers, hospitals, clinics, nursing homes, practice groups, physicians, nurses, allied health professionals, health insurance companies, major universities, and medical associations.

Specifically, our health care lawyers have extensive experience in the following areas:

• Administrative Proceedings
• Anti-kickback laws
• Appellate Issues Specific to Health Care
• Certificate of Need
• Clinical Research
• Compliance Programs
• Development and Land Use
• eHealth
• Employment
• EMTALA
• Environmental
• ERISA
• False Claims Act
• Fraud and Abuse
• Health Insurance
• HIPAA
• Intellectual Property
• Lobbying/Legislation
• Managed Care
• Medical Malpractice
• Medical Staff/Peer Review Issues
• Medical Waste
• Mergers and Acquisitions
• Pharmaceutical and Medical Devices
• Stark laws
• State Licensing and Disciplinary Proceedings
• State Regulatory and Administrative Proceedings

Administrative Law, Legislation and Lobbying

The firm's government affairs and lobbying team vigorously advocates on behalf of its health care providers, health care associations, health insurers and managed care companies before the Florida Legislature, Cabinet and executive agencies, including the Office of Insurance Regulation, the Florida Attorney General's office, the Florida Department of Health (DOH) and the Agency for Health Care Administration (AHCA). In addition, the firm's attorneys can represent your interests in any administrative proceeding before these same governmental entities.

Appellate Practice

Our Health Care Practice Group includes board-certified appellate specialists who have extensive experience in handling appeals on health care issues, ranging from issues of credentialing and peer review of staff privileges decisions to hospitalists issues to a wide variety of medical malpractice, hospital and nursing home issues. Our appellate attorneys include former law clerks from numerous federal and state appellate courts as well as a former Chief Judge of Florida 's Second District Court of Appeal and a former Solicitor General of Florida.

Our experience shows that appeals are most successful when they are anticipated. Accordingly, our appellate attorneys are available to assist trial counsel in presenting and preserving potential appellate issues at the trial or administrative level, and then, if necessary, to pursue those issues on appeal or defend the successful results obtained below. Our appellate lawyers can also help frame the record to make an argument that the law on a particular issue should be changed. They likewise can prepare focused amicus curiae briefs in cases presenting important issues for health care providers.

Employment Issues for Health Care Entities

We have extensive experience in the representation of health care employers. Our attorneys' in-depth knowledge of general employment laws and, particularly, the employment laws' application to health care facilities allows us to assist health care employers in all aspects of employment, human resources, and labor relations. We represent employers in any employment or labor disputes in federal and state courts as well as in administrative hearings, including employee or physician disciplinary issues, grievances, and the hiring or firing of employees. Additionally, we provide preventative advice, prepare appropriate policies and procedures, assist in the resolution of benefit issues, and negotiate employment contracts or physician associations.

Health Care Compliance

We advise providers on important elements of an effective health care compliance program in order to respond to guidelines preferred by the Department of Health and Human Services Office of the Inspector General and other governmental agencies. First and foremost, an effective compliance program provides safeguards to ensure that providers are complying with applicable federal and state regulations. In addition, a successful compliance program improves the quality of patient care, creates a centralized location for important information, demonstrates the organization's commitment to legal and ethical conduct, establishes procedures for reporting and investigation of improper conduct and reduces the provider's exposure to legal sanctions. Specifically, on Medicare and Medicaid issues, we handle reimbursement disputes with federal and state agencies. Our firm also addresses various compliance issues relating to EMTALA, HIPAA, Stark, and anti-kickback laws.

Health Care Fraud and Abuse

We have a broad range of experience defending companies and individuals against fraud and abuse claims on both the federal and state levels. Our lawyers have substantial trial experience and defend as well counsel companies, physician groups, hospitals, and other health care providers in health care fraud cases. We have defended our clients against all types of fraud and abuse allegations, including claims pertaining to Medicare, Medicaid, Tricare (the U.S. Department of Defense's Military Health Care System) and Champus (the health care program that covers medical necessities). We have attorneys who have previously served as federal prosecutors, state prosecutors, and as counsel for the Florida Department of Health, who bring to our firm invaluable knowledge of fraud and abuse regulations.

Health Facility Representation

Carlton Fields has over a century of experience in representing a number of hospitals and hospital systems, nursing homes, hospice organizations, home health agencies, pharmacies and professional providers. Our clients are both not-for-profit and for-profit, and include public hospital authorities, teaching hospitals, children's hospitals, home health agency chains, physicians and physician groups, and other licensed health care professionals. We represent health care facilities in interpreting state and federal reimbursement statutes and regulations, investigations of health care facilities, accreditation issues, corrective action plans, contract procurements, and rule challenges. We also represent hospitals in medical staff issues, including peer review investigations and in preparing professional service and employment agreements with physicians.

We are experienced in representing clients before Florida 's Agency of Health Care Administration (AHCA) on matters relating to licensure and certificates of need for medical facilities. We have worked with AHCA attorneys and staff to resolve issues in a manner favorable to our clients in both the judicial and administrative forums.

Health Insurance and Managed Care

Carlton Fields' representation of health insurance and managed care company interests gives those clients access to a comprehensive array of quality advocacy services within the executive, legislative, and judicial branches of Florida government. Attorneys and government consultants in the Health Care Practice Group have extensive knowledge of health care insurance and managed care regulation, reimbursements, political advocacy, and the health care delivery system as a whole.

The firm's government affairs and lobbying team vigorously advocates health insurance and managed care issues on behalf of its clients before the Florida Legislature, Cabinet and executive agencies, including the Office of Insurance Regulation, and the firm is an active member of the Florida Managed Care Coalition.

The scope of Carlton Fields' health insurance and managed care regulatory representation includes licensure, coverage matters, subscriber assistance claims, bad faith, and litigation. Other areas where the firm has depth includes:

• Rate-making, including administrative rate proceedings, judicial proceedings, and rate arbitration
• Form and product filing approvals
• Statutory accounting, admitted asset, diversification and solvency issues
• Insurance taxation, including premium tax, corporate income tax, retaliatory tax, and special purpose assessments
• Administrative rule challenge proceedings
• Market conduct investigations and cases
• Solvency and receivership actions against regulated entities
• Ongoing compliance issues

Health Professional Regulation

We handle licensure and disciplinary issues before all the health practitioner professional boards in Florida and the Florida Department of Health. We are prepared to represent your interests before any one of the boards to obtain a professional license in Florida. In the event of professional disciplinary investigations, we can represent your interests, and if formal charges are filed against you, we will aggressively defend your case in order to eliminate or minimize any action taken against your professional license. Our attorneys have handled state-wide investigations and litigation of complex medical regulatory cases, including emergency suspension and restrictions of licenses. Our attorneys are knowledgeable in a variety of health care issues, including medical errors, practitioner profiling, internet medicine and prescribing, peer review, coding, physician impairment, sexual misconduct, and numerous patient care issues in most medical specialties. Our firm also assists individual health professionals with health compliance issues in an effort to resolve issues before the state agencies get involved. We can also appear before the boards to address proposed rules that may affect your practice.

Medical Malpractice

Our vast medical malpractice experience includes acute care hospitals, physicians in every specialty, nurses, respiratory therapists, nursing homes and pharmacists. We represent several pharmaceutical houses, HMO's, medical universities and clinics. We have been instrumental in establishing favorable case law for health care providers. Moreover, our attorneys routinely respond to notices of investigation issued under the Agency for Health Care Administration (AHCA), representing licensed health care professionals in the ensuing administrative process.

Pharmaceutical and Medical Device Industry

We have extensive knowledge and experience in litigating pharmaceutical and medical device cases for our national and international clients. We have defended a diverse group of manufacturers and sellers with respect to a wide variety of products in jurisdictions throughout the state of Florida.

Through our representation of numerous industry leaders, we understand their business environment, and efficiently and effectively represent their interests. Carlton Fields has been a leader in developing the law in Florida on such key issues as the learned intermediary doctrine, preemption, market share and the statute of limitations. On the cutting edge, and with more than 30 years of experience working with the pharmaceutical and medical device industries, our lawyers take pride in our client focused strategies.

Services Available

REPRESENTATIVE MATTERS

Anti-kickback Laws

• Represented major hospital chain in anti-kickback investigation conducted by Department of Justice
• Advised healthcare providers on compliance with federal and state anti-kick back laws

Antitrust

• Represented hospital in defense of antitrust claims brought by medical staff physician
• Advised hospital in connection with potential merger with competing health care facility
• Represented hospital in connection with government investigation of proposed merger of area hospitals
• Advised hospitals in developing and implementing antitrust compliance programs

Appellate & Trial Support Representation

• Represented health insurance company in securing reversal of $79.6 million jury verdict, the largest punitive damages award obtained by an individual plaintiff in Florida history
• Represented hospital regarding whether Consent for Medical and Surgical Treatment form constitutes an express contract between hospital and patient
• Represented hospitals in obtaining reversal of jury verdicts in favor of physicians
• Represented nursing homes on peer review claims where plaintiffs sought to avoid agreements to arbitrate and limitation of liability
• Provided legal issues support to nursing homes at trials resulting in defense verdicts, and upheld those verdicts on appeal
• Provided legal issues support to hospital in negligent credentialing trial that resulted in a defense verdict, and upheld that verdict on appeal
• Provided legal issues support in numerous medical malpractice actions and handled appeals Provided advice and representation on caps constitutional issues of statutory medical malpractice

Certificate of Need

• Represented numerous health care providers in Certificate of Need filings, including projects for new hospitals, hospice programs, hospice inpatient facilities, nursing homes, open-heart surgery, comprehensive medical rehab beds, psychiatric and substance abuse beds, long-term acute care hospitals and transplant services
• Represented hospital system in Certificate of Need matter involving a $100+ million hospital project in Brevard County, Florida
• Represented hospital system in Certificate of Need matter involving a $90+ million hospital project in Duval County, Florida

Clinical Research

• Assisted hospitals within national chain to negotiate clinical trial agreements, including appropriate indemnification provisions
• Advised hospitals concerning compliance issues related to clinical trials
• Negotiated agreements on behalf of hospitals with various national foundations that operate data collection registries for certain illnesses
• Provided advice to hospitals concerning data collection concerns related to research, including privacy and security issues related to disease registries

Compliance Programs

• Advised clients on corporate compliance guidelines
• Advised physician and pharmaceutical clients on compliance matters, including fraud and abuse issues
• Advised pharmaceutical clients concerning reimbursement from Medicare and Medicaid, including the implementation of Medicare Part D
• Assisted clients in filing for Medicaid and Medicare certification
• Advised providers on effective health care compliance programs in response to guidelines from the Department of Health and Human Services Office of the Inspector General

Development and Land Use

• Assisted hospitals and their associated development before state and local government in development activities, including negotiation of development and concurrency agreements

eHealth

• Advised hospitals concerning use of medical screening software, prepared agreements aimed at bringing vendor's software into HIPAA security compliance and reduce hospital's HIPAA risks
• Worked with national hospital chain to prepare documents and address compliance risks associated with a data collection project involving medical devices for quality assurance purposes
• Discussions with representative from the Universal Service Administrative Company regarding reimbursement of telecommunications costs in rural and underserved areas for the purposes of implementing telemedicine and eHealth programs

Employment & ERISA

• Represented hospital against claims by physician that denial of request to take specialty call was discriminatory
• Obtained summary judgment on behalf of hospital against claims by physician that he was "employed" by the hospital and that the non-renewal of an exclusive contract with client was result of discrimination
• Represented hospital client in connection with employee claims of multiple chemical sensitivity disorder/indoor air quality issues

EMTALA

• Advised and represented hospital clients regarding EMTALA inquiries and alleged violations

Environmental

• Advised and represented hospital clients regarding alleged violation of biomedical and radioactive waste rules (civil and criminal allegations)
• Advised and represented medical waste incinerator regarding permitting and compliance issues
• Advised hospitals regarding pre-purchase due diligence issues, including mold, asbestos and other indoor air quality issues related to purchase of existing structures
• Represented hospital in connection with employee claims of multiple chemical sensitivity disorder/indoor air quality issues

False Claims Act

• Represented pharmacy chain in connection with federal False Claims Act investigation involving the partial filling of prescription medicine
• Represented ambulance management company in False Claims Act investigation
• Represented provider in False Claims Act lawsuit filed by state

Fraud and Abuse

• Defended anesthesiology practice group in federal False Claims Act investigation
• Defended oxygen durable medical equipment provider in federal Medicare fraud investigation
• Defended health care provider in Attorney General's Office Medicaid fraud investigation
• Defended large physician group in federal False Claims Act investigation
• Defended health care provider of prison medical services in attorney general's office Medicaid fraud investigation
• Obtained approximately $11 million jury verdict on behalf of national insurance company relating to allegations of health care billing fraud in personal injury protection (PIP) claims by medical providers

Health Insurance and Managed Care

• Handled various corporate matters for a major insurance provider in Florida, its subsidiaries and affiliates
• Represented HMO in Medicaid recoupment claims with the Florida Medicaid Program
• Represented HMO in lawsuit to receive over payments made to health care provider
• Representation before the Office of Insurance Regulation

Health Facility Representation

• Represented hospitals in lawsuits filed by former patients under the Fair Credit Reporting Act and Fair Debt Collecting Practices Act and its state counterparts
• Provided large nationwide hospital chain with advice on how to comply with the Fair Credit Reporting Act and Fair Debt Collecting Practices Act and its state counterparts in its billing and collections efforts
• Represented hospitals in lawsuits brought by former patients alleging excessive charging or charges in excess of usual and customary levels
• Represented hospitals in wide variety of contract and business tort lawsuits relating to relationships between the hospital and vendors/providers of goods and services
• Advised hospice with regard to physician contract issues
• Corporate transactions for major state university's health sciences center and faculty practice plan
• Advised mental health centers
• Home health care transactions
• Handled a broad range of licensure and regulatory issues for Florida hospitals, hospice organizations, nursing homes, home health agencies, assisted living facilities, pharmacies, and physicians
• Represented hospitals in litigation and arbitration proceedings enforcing physician recruiting agreements
• Represented hospitals in litigation and arbitration proceedings enforcing employment agreements
• Represented hospitals in litigation and arbitration proceedings enforcing practice management agreements
• Represented hospitals in litigation enforcing lease agreements
• Represented hospitals in actions collecting funds owed by physicians and medical practices

HIPAA

• On-going advice to three national hospital chains regarding HIPAA privacy and security compliance
• Assisted hospital in conducting internal investigation, including staff interviews, following HIPAA privacy complaint
• Counseled national hospital chains concerning investigations of HIPAA complaints by the federal Office for Civil Rights
• Prepared a multi-state HIPAA - State law preemption analysis for national hospital chain
• Reviewed and updated HIPAA policies and procedures for national hospital chain
• Assisted national hospital chain with HIPAA compliance concerns related to its creation of a clearinghouse to perform claims and billing functions in-house
• Advised hospitals concerning use of medical screening software; prepare agreements aimed at bringing vendor's software into HIPAA security compliance
• Counseled individual health care professionals on compliance with HIPAA, including advice on what to produce in litigation that involves patient medical information
• Counseled health care providers about compliance with HIPAA, including how to comply if they are in violation
• Provided proactive counsel to health care providers to prevent HIPAA violations

Intellectual Property

• Represented health care providers in trademark, trade secret, and non-competition matters
• Defended medical equipment companies in trademark matters
• Defended medical equipment manufacturers and distributors against patent infringement claims

Lobbying and Legislation

• Insured adequate funding of State of Florida Employees Group Insurance Trust Fund for client that provides health insurance coverage to those employees
• Drafted and secured passage of general bill enabling addition of hospital beds in high growth counties by legislative fiat notwithstanding the requirements of Certificate of Need
• Drafted and secured passage of local bill creating the North Sumter County Hospital District
• Drafted portions and helped secure passage of bill relating to substantial reform of Certificate of Need
• Substantially amended bill relating to codification of National Association of Insurance Commissioners' standards into Florida's Insurance Code

Medical Malpractice
Litigated matters relating to medical malpractice claims involving a variety of clinical issues, including cases alleging:

• Negligent credentialing of physicians by hospitals and other health care entities
• Negligent supervision by network and contract providers of clinical employees
• Negligent performance of lab work which resulted in unnecessary surgery
• Negligent surgical laceration of major organs and vessels during laparoscopic surgery
• Negligence of code team
• Negligence of operating room nurses and surgeons in failure to count instruments/sponges
• Failure to administer sufficient anesthesia before and during surgery
• Failure of clinical laboratory to report in a timely manner specimen test results
• Failure of clinical laboratories to obtain immediate intervention when testing results fall within the range of panic values
• Failure of nurses to intervene during physician's inappropriate use of mid- or high-forceps
• Failure of nurses to recognize impending hypoxia in post-surgical, newborn, and psychiatric patients
• Failure of nurses to recognize the complications of intra-operative anesthesia in a recovery room patient
• Failure of hospital in permitting, or failing to monitor properly, allegedly controversial spine surgery (posterior and anterior lumbar interbody fusion) resulting in a series of bad results
• Nursing failure to implement physician orders regarding patient restraint
• Nursing failure to notify physician of clinical changes and abnormal lab reports
• Nursing negligence in draping the wrong limb, and presenting wrong baby for circumcision
• Negligent diagnosis of vascular compromise in blood vessels to the eye
• Negligent neonatal ward supervision and treatment of premature infants

Medical Staff/Peer Review Issues

• Provided detailed advice in connection with peer review due process procedures
• Represented hospital against claims by physician that disciplinary action taken by hospital was otherwise motivated by personal animus and other improper reasons
• Represented hospital against claims by physician that disciplinary action by hospital resulted in defamation and was improperly taken
• Represented hospital against claims by physician that disciplinary action taken by hospital was not medically justified
• Represented hospital against claims by physician for denial of application for privileges
• Represented hospital against claims by physician that revocation of medical staff membership was improper
• Represented hospital against claims by physician that summary suspension of clinical privileges violated medical staff bylaws
• Represented hospital against claims by physician that summary suspension of clinical privileges was motivated by malice
• Represented hospital against claims by physician that disciplinary action by hospital tortiously interfered with physician's patient, physician and managed care relationships
• Represented medical executive committees in peer review proceedings
• Represented boards of trustees in connection with appeals from peer review hearings

Medical Waste

• Advised and represented hospitals regarding alleged violation of biomedical and radioactive waste rules (civil and criminal allegations)

Mergers & Acquisitions

• Transfer of psychiatric hospital
• Acquisitions of nursing homes
• Transfer of mental health center
• Represented client in the sale of a hospital owned by county, and in negotiation of complex indigent care plan
• Represented hospital system in purchase of hospital
• Represented client in sale of two community hospitals

Pharmaceutical and Medical Device Industry
Managed products liability cases on behalf of large national and international corporations for a wide variety of medical devices, including:

• Personal injury claims arising from knee and hip implants
• Fractured titanium rod during fusion surgery
• Contact lenses personal injury claims
• Alleged injury caused by leakage due to failure of circular stapling device during gastric bypass procedure
• Claims of infertility from IUD's
• Florida counsel in connection with litigation relating to stent device
• Florida counsel regarding recall of acetabular shells (management of statewide mass tort litigation)
• Personal injury claims arising from pedicle screws
• Silicone gel breast implant litigations claiming the implants caused systemic diseases
• Claim of disability caused by allergy allegedly developed from exposure to latex gloves
• Fen Phen diet drug class action litigation
• HRT class action litigation
• Claim against pioneer drug manufacturer for injury caused by generic version of drug
• Claim for negligent labeling on child's medicine
• Negligent Design claim based on allegedly defective penile implant

Physician Self Referral

• Advised clients in regards to compliance with Physician Self Referral and Regulations

Stark Laws

• Advised clients in regards to compliance with Stark Laws and Regulations

State Licensing & Disciplinary Proceedings

• Extensive experience handling emergency suspensions and restrictions of healthcare practitioners' licenses, including pharmacies, pharmacists, medical and osteopathic physicians, dentists, chiropractors, nurses, psychologists, and mental health professionals
• Defended physician in disciplinary investigation relating to his responsibilities as medical director
• Represented multiple physicians, nurse practitioners, and nurses in licensure proceedings before the Florida Department of Health, Florida Board of Medicine and Florida Board of Nursing
• Handled multiple standard of care cases before Department of Health
• Handled multiple sexual misconduct cases before Department of Health
• Handled multiple improper prescribing cases before Department of Health
• Handled multiple impaired practitioner cases before Department of Health

State Regulatory & Administrative Proceedings

• Represented several national pharmacies regarding their regulatory needs in Florida, including numerous change of ownership/licensure filings before the Board of Pharmacy and provider enrollment filings with Florida Medicaid
• Represented various providers in Medicaid recoupment proceedings
• Represented pharmacies in audit disputes with Florida Medicaid program
• Represented physician in Medicare fraud investigation
• Represented pharmaceutical company in Medicaid audit
• Defended pharmacy during governmental investigation
• Handled multiple hearings on behalf of HMOs before statewide Subscriber Assistance Panel