The following are examples of recent work completed on behalf of health care clients in the area of regulatory compliance. The examples demonstrate the extensive experience the lawyers in the health care practice:
Antitrust
Clinical trials
Contract agreements
Corporate transactional analysis
Emergency Medical Treatment and Labor Act
Fraud and abuse
Litigation
Health facility compliance
HIPAA, data security, data breaches
Managed care
Pharmaceutical and device
Reimbursement
Antitrust
Alston & Bird has one of the largest antitrust practice groups in the United States and has been active in providing antitrust counseling and defense to clients in the health care industry for over 30 years. Given the increasingly severe statutory sanctions for criminal violations of the antitrust laws (10 years imprisonment, $100 million in fines for corporations, and $1 million in fines for individuals) and the onerous civil penalties for antitrust violations (treble damages), recovery of reasonable attorneys fees, and expensive discovery because of the voluminous document production usually involved in antitrust cases, Alston & Bird has proactively and successfully advised clients to avoid or lessen the likelihood for successful antitrust claims. When clients have been named as defendants in antitrust cases or have been served with federal grand jury subpoenas or Civil Investigative Demands, Alston & Bird has successfully defended clients against claims of price-fixing, group boycotts, market allocations, refusals to deal, illegal tying arrangements, monopolization, and attempts to monopolize markets. Alston & Bird has also advised health care clients in a wide variety of joint ventures and mergers and acquisitions.
- When the Department of Justice Antitrust Division and Federal Trade Commission issued their "Statements of Antitrust Enforcement Policy in Health Care," with express client permission the firm served as both counsel to the American Hospital Association and consultant to the Antitrust Division in developing the Policy Statements
- Representing hospital in West Virginia in Department of Justice investigation into allegations of market allocation with competing hospital
- Defending Florida physician group against allegations of price-fixing, group boycott and monopolization arising from formation of outpatient clinic
- Representing Northeastern medical school in a consortium of hospitals exploring various joint venture opportunities
- Defending numerous hospitals throughout the country in antitrust claims arising from terminating or denying physicians staff privileges
- Representing pharmaceutical clients and medical equipment manufacturers in successfully obtaining government approval of multibillion-dollar mergers and acquisitions
- Advising major university hospital system in joint venture with proprietary hospital system (back to list)
Clinical trials
Alston & Bird represents sponsors, research sites and physician-investigators in all aspects of the clinical trial process. Our clients participate in Phase I, Phase II, Phase III, and Phase IV, drug, device and data studies, as well as disease management and pharmaco/economic outcome studies. We advise clients on reimbursement requirements, fraud and abuse issues, and compliance with FDA and other state and federal government regulations.
- Internal review of clinical trial program for major hospital chain
- Drafting and reviewing hundreds of clinical trial agreements on behalf of pharmaceutical companies, principal investigators, and study sites
- Advising large laboratory client on the implications of federal and state fraud and abuse, and clinical conduct and privacy laws on clinical trial sponsorship
- Conducting daily contract reviews and providing regulatory advice for the research department of a large private hospital system, including negotiation of clinical trial agreements with sponsors, site management organizations and contract research organizations (back to list)
Contract agreements
Health care providers and organizations must adapt their business practices regularly to an ever-evolving array of regulatory and financial regulations. The Alston & Bird regulatory compliance team is composed of seasoned attorneys well-skilled at drafting and reviewing all types of business agreements to allow its clients to enter into novel, sophisticated arrangements without running afoul of their wide range of compliance obligations. Alston & Bird provides contracting services to a variety of health care clients, including academic medical centers, clinical laboratories, medical products and DME suppliers, health care providers of all types, health information technology companies, health plans, hospitals and health systems, insurers and managed care organizations, medical billing and clearinghouse companies, medical device and pharmaceutical manufacturers, nursing homes, physicians and physician groups, and professional trade associations, as well as investment banks, venture capital firms, and other institutions that finance the health care industry.
- Corporate documents for a variety of business combinations, including mergers, tender offers, asset and stock purchases, leveraged transaction, recapitalizations, spin-offs, joint ventures, bankruptcy acquisitions and competitive auctions Medical director agreements Management services agreements employment agreements
- Patient transfer agreements
- Physician recruitment agreements
- Clinical trial agreements
- HIPAA-compliant provisions in a wide range of agreements
- Physician syndication documents
- Medicare discount and rebate program agreements
- Participating pharmacy agreements
- Hospital services agreements and multifacility agreements (back to list)
Corporate transactional analysis
Alston & Bird’s corporate health care lawyers work side by side with members of our firm’s Regulatory Compliance, Tax, Government Investigations, Technology, Life Sciences, and other groups to assemble top-notch teams to accomplish our clients’ transactional objectives.
Regulatory Compliance counsel play a key role in reviewing any transaction involving a health care entity. Our Regulatory Compliance lawyers assist in due diligence efforts, such as document, policy and contract reviews. They advise on pricing and potential compliance issues and can dramatically affect the course of the transaction in a positive manner. Regulatory Compliance lawyers counsel buyers and sellers on the various change of ownership requirements that must be met at the federal, state and local levels in order to “transfer” licenses and to obtain the proper consents to engage in a transaction. Regulatory Compliance counsel also advise on potential fraud and abuse issues in a given transaction and assess the various risks for breach for warranties and indemnification.
- Advising health care entities (including hospitals, hospices, dialysis centers, CCRC’s, youth centers) on change of ownership, health care facility state licensure issues in all 50 states
- Representing large physician group practice associated with an academic medical center in establishing a joint venture among its medical center and its physician provider groups for consolidated billing and collection services
- Serving as primary corporate and regulatory counsel to top dialysis company in several dozen acquisition transactions around the country
- Advising in multiple corporate transactions involving hospice facilities including advice relating to complex billing issues and navigating the certificate of need and licensure process
- Counseling in the sale of continuing care retirement community licensure and certificate of need process where community had not previously obtained certificate of need as required by law (back to list)
Emergency Medical Treatment and Labor Act of 1986
Alston & Bird advises hospitals and physicians located across the country in responding to the Emergency Medical Treatment and Labor Act of 1986 (“EMTALA”) actions, and is recognized as a leader in the defense of EMTALA-related Medicare termination actions. EMTALA requires that hospitals meet certain screening, stabilization and transfer obligations for all patients presenting for care of a suspected emergency medical condition. The failure of a health care provider to comply with these obligations poses the risk that the hospital or physician may be fined or even excluded from participation in federal health care programs.
Alston & Bird helps clients understand the EMTALA survey process and can furnish hands-on guidance during an investigation. Our attorneys advise health care systems in drafting and implementing corrective measures and providing on-site education and compliance training. The depth of our EMTALA experience allows our attorneys to prepare a credible and effective response to EMTALA investigations. In addition to representing clients during the investigation phase, Alston & Bird routinely helps clients revise and implement EMTALA policies and procedures, handle QIO proceedings and civil monetary penalty demands.
- Assisting a Midwestern multi-hospital health system in responding to allegations that it failed properly to screen a gunshot victim
- Assisting an academic medical center in responding to charges that it failed to accept the transfer of a patient needing highly specialized neurosurgical care.Representing a health system in responding to allegations that it failed to accept and treat a pregnant minor
- Assisting an academic medical center in responding to citations that it failed to screen a patient properly where the patient presented and then left the facility in a taxicab
- Assisting a rural hospital in responding to allegations that it improperly locked its emergency department
- Advising a trauma center against allegations it improperly refused transfer of trauma victims when it had capability and capacity (back to list)
Fraud and abuse
Alston & Bird’s Health Care Regulatory Compliance and Governmental Investigations teams advise clients daily on whether certain activities may implication the fraud and abuse laws – including the Anti-Kickback Statute, the Stark Law and the False Claims Act, as well as corresponding state laws.
Our regulatory attorneys also work closely with our corporate team in structuring health care joint ventures, and providing guidance in connection with corporate due diligence. Our Regulatory Compliance Group develops compliance programs, employee training manuals and web-based modules to assist client in their regulatory compliance.
Our Government Investigations Team is one of the most experienced in the country. With more than 20 attorneys who have federal prosecution and defense trial experience, we believe our group gives a decided edge to clients faced with the prospect of a government investigation, enforcement action, or whistleblower lawsuit. Our experience, depth, and understanding of government prosecution perspectives lets us aggressively protect our clients from overreaching authorities, manage the risks inherent in any investigation, coordinate the defense of parallel criminal, civil, and administrative actions, and proactively resolve these matters more economically and efficiently.
- Obtained the dismissal of an indictment against our client in a major federal health care investigation
- Represented a client in a major civil False Claims Act investigation where the relater was barred from any share of the settlement, and we have been involved in many legal challenges to provision of the FCA
- Defended a hospital in connection with parallel criminal and civil government investigations and a related qui tam lawsuit
- Represented a government scientist in connection with a U.S. Congressional investigation
- Represented a national laboratory in connection with a nationwide criminal and civil Department of Justice investigation
- Served as counsel in group appeals for more than 200 hospitals in reimbursement disputes with Medicare
- Conducted internal review of whistleblowers allegations that employees were forging physicians signatures in order to complete medical records (back to list)
Litigation
Alston & Bird specializes in all types of health care litigation. From products liability class actions to medical staff hearings, our attorneys have the expertise and skill to represent your interests. Below are some of the types of disputes we handle on a regular basis.
- EMTALA Medicare and Medicaid appeals
- Medical malpractice
- Medical staff hearings
- Professional liability suits
- Certificate of Need appeals
- Antitrust analysis and litigation
- Trade litigation, trademark, trade name and copyright disputes
- Products liability
- Managed care contract arbitration (back to list)
Health Facility Compliance
Alston & Bird’s Regulatory Compliance practice is one of the largest and oldest in the country – drawing on over 60 years of experience in regulatory matters affecting the health care industry at large. Alston & Bird knows facility compliance law. We are intimately familiar with the statutes and regulations that affect health systems, ambulatory surgery centers; dialysis centers, hospice, laboratories, skilled nursing facilities, home health agencies, continuing care retirement communities (to name a few types of entities) and have the practical experience to apply these laws in any given situation. Our Regulatory Compliance lawyers are in daily contact with traditional health care entities, their in-house counsel and compliance officers to advise them on the issues that affect their day-to-day operations.
Our lawyers are unique in that they not only know the law - they are forefront in making the law. We work with Congress and various state legislatures to play a primary role in revising legal, regulatory and policy requirements to address our clients’ needs.
Our attorneys also closely monitor new statutes, regulations and policy developments and stand ready to counsel clients on the issues that concern them. To ensure that our clients stay informed about important regulatory developments, we lecture at national and state seminars, provide educational presentations at our clients’ own compliance meetings, publish client alerts and advisories, and create extranets that allow us to provide secure, individualized compliance counseling in a timely and efficient way.
- Representing over 40 hospitals for day-to-day compliance needs
- Advising hospitals across the country regarding various risk management and compliance issues, including end of life decisions; withdrawal of life-sustaining treatment; do not resuscitate orders, involuntary commitments based on mental health or alcohol/drug issues, privacy, obtaining court orders for blood transfusions; search of patient rooms and belongings due to suspicion of illegal drugs or weapons; surrogate births, adoptions, sentinel events, medical staff issues (including appointment/reappointment), corrective actions, revocation of privileges and fair hearing process; release of medical records, confidentiality of peer review, minors, duty to warn, payment disputes with payors; contracting, uninsured patients, and managed care issues
- Serving as counsel in group appeals for more than 200 hospitals in reimbursement disputes with Medicare.
- Successfully defending over 16 hospitals in Medicare termination and loss of “deemed status” proceedings.
- Representing major hospital chain in JCAHO accreditation denial actions and appeals
- Advising two major hospital chains regarding scope of practice issues for nurse practitioners and physicians assistants in numerous states
- Representing hospital in investigation by multiple state agencies, including Medicaid, regarding psychiatric services
- Representing several hospitals in investigations by state Medicaid Inspector General.
- Acting as primary outside regulatory counsel to top renal dialysis company.
- Drafting a significant number of health care statutes, including one of the first “no code” laws in the country and one of the nation’s most progressive peer review statutes
- Serving as legislative policy counsel and lobbyists for Georgia Hospital Association for over 50 years.
- Conducting internal review of whistleblower’s allegations that employees were forging physicians’ signatures in order to complete medical records
- Advising multiple client regarding internal investigations relating to drug diversions by various health care professionals
- Advising clients on infectious disease lookbacks, including HIV, cyptospira, and hepatitis.
- Representing several hospital systems in graduate medical education contracting and regulatory compliance issues
- Acting as primary outside regulatory counsel to 2 national home health companies
- Successfully representing national hospice company in Medicare fast track decertification proceedings
- Representing clinical laboratories on billing, reimbursement and coding and other regulatory and fraud and abuse issues. Issues covered include whether a service is covered by hospital billing requirements, several different clinical laboratories on coding and billing issues
- Advising one a large provider of air ambulance services, with regard to fraud and abuse issue
- Advising a large medical device manufacturer on coverage of its device and assisted in obtaining a National Coverage Decision
- Advising a manufacturer of a wound care product with its reimbursement and coding strategy for Medicare
- Conducting an internal investigation of an Independent Diagnostic and Testing Facility with regard to its personnel policies (back to list)
HIPAA, data security, data breaches
The federal government enacted extensive privacy and security regulations governing the use and disclosure of patient’s protected health information under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Certain companies must also comply with the HIPAA Transaction and Code Set Standards for the uniform processing of health care claims. These regulations impose stringent requirements on health care providers, health care clearinghouses, health plans, and, indirectly, on the companies with which they share health information.
Our attorneys have advised all types of providers on compliance with HIPAA, including those listed above, as well as EDI companies and financial institutions. Alston & Bird remains at the forefront of national law firms in developing compliance programs for companies affected by HIPAA.
Alston & Bird is also experienced in advising clients in the event of an inadvertent or malicious security breach. From small hospital providers to large for-profit companies, we have navigated companies through the various state and federal laws and reporting requirements relating to privacy and security breaches of health and financial data.
- Developing a comprehensive HIPAA Privacy and Security Compliance Program for state hospital associations and various health care providers and health plans, including preparation of 500 pages of policies and procedures, all form documents, an Internet-based training program, monthly teleconference presentations and a HIPAA hotline
- Advising national health care clearinghouses and physician practice billing and management company on their compliance with HIPAA Privacy, Security and Transaction Standards Regulations
- Advising national package carrier on its compliance with privacy requirements through agreements with its customers that are subject to the HIPAA Privacy Regulations
- Advising international supplemental insurance company on its compliance with HIPAA Privacy Regulations.
Conducting 50 state survey on electronic signature laws
- Counseling for-profit corporation on compliance with HIPAA and state health and financial data security laws in 48 states after potential theft of 50,000 patient records and successfully representing client in corresponding government investigation
- Advising various entities and collaborative ventures on the use and development of electronic medical records systems
- Advising financial institutions and data processing companies regarding the evolving legal landscape for electronic health transactions (back to list)
Managed care
Alston & Bird has been active in advising a wide variety of clients in every aspect of managed care. Our clients include health plans, hospitals and health systems, academic medical centers, non-health facilities, provider networks, including physician-hospital organizations (PHOs), independent practice associations (IPAs), practice management companies and other entities involved in managed care. Our lawyers have broad experience in advising clients on managed care payor licensure, Medicare Advantage Plans, prescription drug plans under Medicare Part D, risk contracting, antitrust issues, managed care network formation, corporate structuring, and mergers and acquisitions.
- Legislative and public policy analysis of issues affecting managed care organizations
- Representation of provider network licensed as health insurer in connection with issues relating to its managed care products, including a Medicare Advantage Program
- Representation of Georgia Hospital Association and its members in connection with new Medicaid managed care program initiated by the State in 2006
- Representation of major national health system in connection with the multistate review of any willing provider laws
- Representation of major national health insurer in connection with its HMO activities in the state of Florida
- Representation of major national health system in connection with HMO licensure and contracting issues in the state of New Mexico
- Representation of major health system in connection with OIG investigation of its managed care activities
- Representation of a number of health insurers in connection with their prescription drug plans under Medicare Part D (back to list)
Pharmaceutical and device
Pharmaceutical manufacturers, distributors, wholesalers, retailers and professionals face a maze of health care laws and regulations. Alston & Bird has extensive experience in the interpretation of professional and entity licensure laws, mail order laws, fraud and abuse laws, and industry guidance such as the PhRMA and AdvaMed Codes and is well-suited to help any company navigate these treacherous waters.
We also have vast experience in health care policy and legislative issues. We were actively involved in representing a variety of health care providers and other health care companies during the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. We routinely advise clients on the implications of Medicare Part B and D coverage and marketing issues.
- Counseling pharmaceutical clients on application of Medicare Part D regulations - including marketing practices, contracting issues, and fraud and abuse compliance programs
- Assisting pharmaceutical wholesaler in interpreting pharmacy regulations regarding credit for unused, expired drugs
- Advising nuclear pharmaceutical company on the applicability of state physician referral restrictions and fraud and abuse laws to their physician relationships
- Advising national pharmaceutical and device manufacturers on the applicability of federal and individual state laws to their marketing and other business activities
- Successfully defending seven health care providers in a state criminal and a Board investigation regarding the alleged use of pre-printed prescriptions by nurse practitioners for professional and personal use
- Working with DEA and state licensure agencies regarding alleged drug diversion by health care professionals from numerous provider pharmaceutical entities
- Obtaining verbal opinions from a Board of Pharmacy and Board’s enforcement agency and advising major pharmaceutical manufacturer, wholesaler and distributor on pharmacy licensure issues relating to mail orders
- Lobbying state legislature for change to pharmaceutical laws relating to mail orders
- Obtaining written and verbal opinions from a Board of Pharmacy regarding the interpretation of various regulations relating to the emergency use of pharmacy and the borrowing of pharmaceuticals
- Drafting comments to proposed Board of Pharmacy regulations on behalf of pharmaceutical claims clearinghouse addressing the purchase of de-identified data from various pharmaceutical entities
- Working with State Medicaid Agency to advise major pharmaceutical company on issues relating to obtaining Medicaid reimbursement for various pharmaceuticals
- Representing pharmaceutical manufacturer in Board of Pharmacy investigation for drug sales representative’s alleged improper drug sampling
- Advising major national pharmaceutical companies with regard to compliance with the discount safe harbor and corresponding state laws
- Counseling international pharmaceutical company on participation in the Medicaid Drug Rebate Program and the intricacies of the Federal Supply Services contracting system
- Advising various payors and Pharmaceutical Benefit Managers concerning compliance with Part D of the Medicare Prescription Drug Program
- Advising several prescription drug manufacturers concerning the impact of the Proposed Rule on Average Manufacturer Price Reporting (back to list)
Reimbursement
Payment for health care items and services, like other areas of health care, involves its own unique and often difficult requirements. To be paid, providers must understand the implications of a host of acronyms, including CPT, HCPCS, ICD-9, APC, PPS, RUC and DRG, to name a few. At Alston & Bird, our attorneys understand the various reimbursement schemes that affect health care providers and can assist clients in understanding how these systems will affect their ability to get paid for their services.
- Serving as counsel in group appeals for more than 200 hospitals in reimbursement disputes with Medicare
- Advising major health care providers with regard to the handling of Medicare, Medicaid and VA overpayments, audits and recoupment actions
- Advising international pharmaceutical manufacturer regarding its participation in the Medicaid Drug Rebate Program
- Drafting comments for a number of trade associations and drug manufacturers regarding the implications of the AMP regulations
- Advising several trade associations, including those representing physicians, imaging providers, laboratories, hospice providers, nursing homes, home health agencies, and pharmaceutical manufacturers, on Medicare reimbursement and payment issues
- Assisting the developer of a new, innovative genetic laboratory test in developing its reimbursement and coding strategy, to obtain Medicare payment
- Providing assistance to a manufacturer of a medical device used in weight reduction surgery in obtaining payment and coverage for its product
- Advising companies specializing in anatomic pathology services on billing requirements for their services and likely payment issues
- Advising a manufacturer of a medical device in the preparation and submission of its request for a New Technology Ambulatory Patient Classification, under the Hospital Outpatient Prospective Payment System
- Advising a provider of long term rehabilitation services on recent changes in Medicare reimbursement issues (back to list)