The Arent Fox Health Care practice, with attorneys and professionals in Washington, DC, New York, and Los Angeles, is a true national practice, focusing on the key areas that define and drive the health care marketplace. Our team of highly experienced health law attorneys and professionals comprises one of the oldest, most respected health care practices, providing counsel and representation on all legal and regulatory aspects of large-scale transactions, regulatory compliance, investigations, and litigation.
Arent Fox’s Health Care attorneys and professionals have long served as trusted advisors to an array of prominent institutional health care providers, including hospital and integrated health systems, long term care facilities, clinical laboratories, dialysis facilities, ambulatory surgery centers, hospice and homecare agencies. We also provide counsel to pharmaceutical and medical device manufacturers on a broad range of issues, including coverage, reimbursement, pricing, regulatory compliance and enforcement actions. In all of our engagements, we work to understand our clients’ needs and anticipate the legal, financial and regulatory challenges they face on a daily basis. Utilizing an integrated, multidisciplinary approach and relying on a deep understanding of the health care industry, we offer clients insights on innovative and cost-effective strategies to help them excel in an increasingly complex and competitive environment.
Our attorneys have experience working in key government policy-making and enforcement agencies, including the US Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), HHS Office of Inspector General (OIG), the Food and Drug Administration (FDA), the US Department of Justice and key congressional committees. We also have a number of attorneys with clinical practice experience.
Arent Fox’s commitment to excellence and dedication to its clients has been widely recognized by some of the most prominent legal ranking organizations in the world. The 2012 joint US News & World Report/Best Lawyers review of “Best Law Firms” named Arent Fox a leading national health care practice. In 2011, Chambers USA and Legal 500 USA recognized the Arent Fox health care as a “leading practice.” In addition, several of our attorneys have been recognized as leading health lawyers by organizations such as Chambers USA, Legal 500 USA and Nightingale’s Healthcare News, among others.
Certification, Accreditation & Licensure
Arent Fox has significant experience advising clients regarding Medicare certification and compliance with the Medicare Conditions of Participation. We have represented clients in decertification actions, and have reviewed and drafted plans of correction to appropriately address deficiencies noted by the Centers for Medicare and Medicaid Services (CMS) and state survey agencies. A number of our attorneys also have clinical experience and a strong understanding of the operational requirements necessary to comply with Medicare regulations.
CMS increasingly relies on accrediting bodies in many health care industries, and Arent Fox lawyers have experience representing health care providers and suppliers before these various entities. We have advised health care providers on The Joint Commission (TJC) accreditation and assist clients in preparing for surveys, answering Requirements for Improvement and challenging adverse recommendations. We have successfully represented hospitals in overturning Preliminary Denial of Accreditation recommendations in appeal hearings. We have also drafted comments to proposed TJC Standards and Elements of Performance to ensure that TJC creates rules that appropriately address health care industry concerns.
Arent Fox attorneys also regularly advise clients regarding state licensing issues, and interface with state licensing agencies on a variety of matters. We advise on compliance with licensing requirements, review statements of deficiency, assist in preparing plans of correction, defend licenses in revocation actions, and represent parties in challenging or attempting to uphold agency decisions. We have also been involved in Certificate of Needs (CON) issues across the United States, and have analyzed the applicability of CON requirements to particular transactions, sought CON requirement clarifications from the responsible agencies, submitted applications, and been involved in hearings both in support of and in opposition to CON applications.
Clinical Trials, Research & IRBs
Arent Fox represents sponsors, contract research organizations, site management organizations, and clinical trial sites, including hospitals and academic medical centers, in clinical trial contracting and compliance.
Arent Fox also represents clients when presenting to institutional review boards (IRBs) for permission to commence research, as well as following discovery that research may have occurred without appropriate permissions. We further advise clients regarding multiple aspects of IRB operations and compliance, including preparation and review of policies and procedures, and issues related to bioethics.
Arent Fox attorneys have conducted investigations on behalf of clients relating to potential research misconduct. As a result of our broad-based health care industry experience, we also understand and advise regarding issues that may overlap with research misconduct, including scope of practice and medical staff issues. As enforcement actions increase, we offer our clients the benefit of such broad-based experience and knowledge related to clinical trials and compliance to assist them in avoiding problems, ensuring they are appropriately protected when problems arise, and resolving and defending enforcement actions.
Compliance Program Development & Counseling
Internal compliance programs are health care companies’ first line of defense in preventing misconduct. Government enforcement actions, revisions to the US Sentencing Guidelines, a series of compliance program guidelines issued by OIG, and mandatory compliance programs issued by some state Medicaid programs should prompt providers to review and update their current compliance programs. Arent Fox assists health care providers and manufacturers in navigating this complex, ever-changing world of government regulation and enforcement.
Our services include:
- Compliance Program Development
- Ongoing Compliance Counseling and Program Assessment
- Compliance Training
- Internal Reviews and Audits
- Investigation Defense
- Corporate Integrity Agreements
- Voluntary Disclosures
Arent Fox provides advice to companies and their officers, boards of directors, board committees, and individual directors in creating and maintaining corporate compliance and governance programs, conducting internal investigations, and responding to allegations of criminal and civil misconduct. We have particular experience in advising nonprofit hospital boards.
False Claims Act
Arent Fox has assembled a formidable team of health care regulatory experts, former federal and state prosecutors, civil litigators, and related professionals to help health care providers and suppliers of all types with False Claims Act (FCA) investigations, compliance issues, and related government program integrity matters. The resulting combination of regulatory and litigation expertise gives our clients substantial resources to respond to a difficult enforcement environment. The health care, pharmaceutical, and device industries are facing heightened scrutiny from the Centers for Medicare and Medicaid Services (CMS), the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS), Office of Civil Rights (OCR), the Department of Justice (DOJ), state Medicaid Fraud Control Units (MFCU), state and federal health care program administrative agencies, and a broad range of government contractors tasked with various program integrity and auditing functions.
This heightened enforcement has had meaningful consequences. In 2011 and 2012, CMS revoked the billing privileges of more than 14,000 providers and suppliers, which is more than double the number revoked in the previous two years. In some states the number of revocations has quadrupled. In 2012, the government recovered a record-breaking $4.2 billion from providers, suppliers, and manufacturers bringing total fraud recoveries for the past four years to $14.9 billion dollars — more than twice the prior four-year period.
The Arent Fox team is highly experienced in the settings in which FCA cases often arise. Our team includes professionals with deep experience both in counseling clients in complex regulatory compliance matters and investigations, and in litigating when necessary. On the regulatory side, our lawyers include former HHS and OIG counsel, a Medicaid Inspector General, certified professional coders and clinicians as well as nationally recognized experts in Medicare regulations, the anti-kickback statute, and the Stark Law. Our litigators include a former federal district court judge, a US Attorney, the former Chief of Government Fraud Section (Los Angeles), assistant US attorneys and an assistant district attorney, and an OIG Senior Trial Attorney. All of them have been at the forefront of health care criminal, civil, and administrative enforcement actions. With both government and private practice experience, the Arent Fox team knows how to navigate enforcement and regulatory matters.
Where our clients have been unable to avoid litigation, we have won and successfully settled many major cases in the health care and pharmaceutical areas. We have advised hospitals, nursing homes, hospices, home care agencies, medical device and pharma manufacturers, academic medical centers, and a broad range of other health care providers and suppliers, as well as clinical researchers and health care practitioners who have faced FCA allegations.
Our areas of concentration include the following:
- Compliance Program Development and Counseling
- Coverage and Reimbursement
- Fraud and Abuse Audits and Investigations
- Government Enforcement/ False Claims Defense
- Overpayments, RAC & Payment Appeals
- Pharmaceutical Pricing and Compliance
- DOJ, OIG, OMIG, ZPIC, OCR, RAC, MIC and MAC Medical Reviews, Audits, and Investigations
We have experience defending allegations of the following:
- Billing and coding fraud
- Failure to comply with Medicare and Medicaid payment and coverage requirements
- Anti-Kickback Act violations
- AWP, Best Price, 340B, ASP, and other pricing manipulation
- Off-label marketing
- Physician self-referral (Stark Law) violations
- False certification of medical necessity
- Clinical research fraud
- Whistleblower retaliation
- Privacy breaches
Some of the services we provide include the following:
- Representing providers in Department of Justice (DOJ) investigations and litigation.
- Representing providers in audits and investigations by the Office of the Inspector General (OIG), Office of the Medicaid Inspector General (OMIG), Zone Program Integrity Contractors (ZPIC), Recovery Audit Contractors (RAC), Medicaid Integrity Contractors (MIC) and Medical Administrative Contactors (MAC), and Office of Civil Rights (OCR) for HHS (HIPAA).
- Representing drug and device manufacturers in Medicare and Medicaid fraud and pricing investigations and litigation, including managing responses to state and federal investigative subpoenas.
- Performing audits, identify compliance risks and formulate Corrective Actions Plans.
- Preparing clients for on-site visits by government investigators, auditors and surveyors.
- Challenging billing privilege suspension, revocation or program enrollment termination.
- Guiding clients through new provider program enrollment and revalidation of existing provider eligibility.
- Conducting internal compliance investigations and, when necessary, assist with voluntary disclosures and repayments.
- Providing independent review and assessment of claims, and counsel on reimbursement, coding and billing issues.
- Providing compliance training, whether generalized or tailored to a specific need or issue.
Our practice includes counseling and advising clients in the development and implementation of strategies to minimize FCA exposure. Arent Fox works proactively with clients to develop effective compliance programs and training tailored to each client’s regulatory environment. We audit and evaluate existing compliance programs to identify and correct potential weak points. We also guide clients through government program audits, preempting unnecessary disputes and litigation. We also work with our employment law colleagues to help clients address the disruptive effect of whistleblowers within their organizations without running afoul of the FCA’s anti-retaliation provisions. When necessary, we assist our clients with repayments, voluntary disclosures, settlement negotiations, and the implementation of corporate integrity agreements or corporate monitoring programs. Our attorneys understand the collateral consequences that can result from FCA litigation, and we help clients avoid or defend against exclusion, suspension, or debarment.
Arent Fox also offers a full suite of proactive compliance assessment and advisory services to identify and address potential problems and vulnerabilities before the government investigators are at the door. Our team of health care compliance professionals and attorneys is uniquely qualified to prepare clients for the overwhelming challenges they will confront with full implementation of the Affordable Care Act.
Fraud & Abuse Compliance
Arent Fox is an industry leader on the numerous complex legal requirements that apply to relationships among providers, suppliers and other companies doing business in the health care industry, as well as their relationships with physicians. Our lawyers are nationally recognized for their expertise and experience counseling clients on the Anti-Kickback Statute, the Stark Law, the False Claims Act, the laws relating to beneficiary inducement prohibitions, civil monetary penalties, exclusion, fee splitting, the corporate practice of medicine, and their State counterparts. In addition, Arent Fox attorneys have deep experience with the myriad Medicare and Medicaid reimbursement issues that often form the basis for fraud and abuse enforcement.
We have advised hospitals and health systems (including specialty hospitals such as LTACHs, children’s hospitals and AMCs), nursing homes, hospices, home care agencies, medical device and pharmaceutical manufacturers, ambulatory surgery centers, clinical laboratories, therapy companies, and a broad range of other health care providers and suppliers, as well as clinical researchers and health care practitioners.
Our team is at the forefront of health care compliance and includes professionals with decades of experience counseling clients on complex regulatory matters, including former HHS and OIG counsel, a Medicaid Inspector General, certified professional coders and clinicians as well as nationally recognized experts in the fraud and abuse laws and Medicare requirements.
Our practice includes advising clients on the development and implementation of strategies to minimize exposure under the fraud and abuse laws; working proactively with management, employees and Board members to develop effective compliance programs, policies and training tailored to the specific regulatory environment. We help conduct internal audits to evaluate specific regulatory issues as well as overall compliance program effectiveness. Arent Fox attorneys frequently assist clients in determining when a compliance failure creates overpayment liability, assessing the scope of potential liability and making disclosures to the appropriate government entity.
Another key part of our practice involves guiding clients through government-initiated audits, limiting the audit’s scope where possible, and preempting unnecessary disputes and litigation. Where our clients have been unable to avoid litigation, we have won and successfully settled many major cases.
We have experience defending matters related to:
- Billing and coding errors (or alleged fraud) related to Medicare and Medicaid payment and coverage requirements (on issues ranging from inpatient admission/observation status to the DRG payment window, appropriate level of supervision, use of modifiers, and services furnished by excluded providers)
- Government medical reviews, audits and investigations initiated by agencies such as the Department of Justice (DOJ), the Office of Inspector General of the Department of Health and Human Services (OIG), the Medicare Administrative Contractors (MACs), the Recovery Audit Contractors (RACs), the Zone Program Integrity Contractors (ZPICs), and Medicaid Fraud Control Units (MFCUs)
- Challenging overpayment determinations (especially by RACs) through administrative appeals
- Clinical research fraud
- Challenging billing privilege suspension, revocation or program enrollment termination.
Our attorneys understand the collateral consequences that can result from fraud and abuse investigations, and we help clients avoid or defend against exclusion, suspension, or debarment.
Government Investigations & Litigation
Arent Fox has assembled a formidable team of health care regulatory experts, former federal and state prosecutors, seasoned litigators, and related professionals to help health care providers and suppliers in all types with civil, criminal, and administrative investigations and litigation related to the False Claims Act (FCA) and other federal and state statutes. Our litigators include a former federal district court judge, a US Attorney, the former Chief of Government Fraud Section (Los Angeles), assistant US attorneys, an assistant district attorney, an OIG Senior Trial Attorney, and a JAG Chief Judge. Our regulatory experts also include numerous former government officials, who have spent decades developing expertise on the applicable Medicare, Medicaid requirements, the Stark Law, the Anti-Kickback Statute and other state and federal fraud and abuse laws, and are recognized experts in the field. The resulting combination of regulatory and litigation expertise gives our clients substantial resources to respond to an extremely difficult enforcement environment. In addition, Congressional investigations of health care providers, suppliers, and manufacturers are becoming commonplace. Our firm is based in the nation’s capital, making us a preferred law firm for clients needing Washington, DC experience, and our Government Relations practice includes two former Senators, a former Congressman, and former Congressional senior staff who routinely advise clients on their interactions with Capitol Hill, including in the context of investigations.
We routinely counsel clients under investigation by numerous federal and/or state agencies, including the DOJ — both Main Justice and US Attorneys’ offices throughout the country, the FBI, the OIG, Medicaid Fraud Control Units, and state Attorney General offices. These investigations have involved allegations of billing for medically unnecessary services, allegations of fraudulent billing, upcoding, improper inpatient admissions, kickbacks, Stark Law and kickback violations, wrongdoing during clinical research, and violations of the Prescription Drug Marketing Act. Increasingly, many of these investigations have both a criminal, as well as a civil, component, span multiple years and require the review and production of hundreds of thousands of documents including ESI. Arent Fox attorneys frequently work with the government to limit the scope of the required production to decrease the risk of exposure and dramatically reduce the cost for clients. Further towards this end, we have attorneys and other professionals help identify the best and most cost-effective technology platforms to expedite the document review process. Depending on the needs of the case and client, we also frequently use our trained teams of paralegals and attorneys to perform the document review as expeditiously as possible.
Bringing together experienced advisers from our health care, litigation/white collar, and government relations practices, Arent Fox has helped clients resolve many investigations early in the process through a cooperative effort leading to favorable settlements or, in some cases, no liability whatsoever.
HIPAA / Health Privacy & Security
Arent Fox began advising clients in matters involving the privacy and security of health information long before the final promulgation of the Privacy and Security Standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In fact, we represented clients before Congress and HHS throughout the negotiations of the Administrative Simplifications Provisions of HIPAA and the crafting of the final regulations. We also developed a comprehensive model HIPAA compliance program that enables health care providers to implement the Federal Privacy Standards in a systematic and efficient manner.
Given the depth of our HIPAA experience, we are uniquely positioned to provide our clients with a comprehensive, cost-effective means to incorporate new HIPAA and HITECH requirements into existing compliance programs, assess their obligations under the new data breach notification requirements, and unravel the complex HIPAA issues that frequently arise in the context of clinical research. Clients facing a HIPAA enforcement action can turn to Arent Fox with confidence knowing that one of our attorneys was involved in the resolution of the largest HIPAA enforcement case to date.
Home Health Care
The Arent Fox Health Care practice group is a leading legal services provider to Home Health Agencies throughout the United States. We advise them on regulatory matters, fraud and abuse issues (e.g., anti-kickback statute, Stark Law, False Claims Act, exclusions), audits, investigations, surveys, reimbursement, contracts, compliance programs, training, corporate structuring, transactions, administrative appeals, state and Federal litigation, government relations, HIPAA and HITECH, and managed care relationships. We represent Home Health Agencies on licensure, certification, coverage and billing issues; conduct internal investigations; defend against Federal and state investigations and audits, involving the Department of Justice, state Departments of Health, the Office of the Inspector General, state Offices of Medicaid Inspector Generals, Medicaid Fraud Control Units, Zone Program Integrity Contractors, Medicaid Integrity Contractors, Recovery Audit Contractors; respond to survey and certification or accreditation deficiencies; and act as general counsel, including labor and employment matters. We conduct compliance audits, and implement compliance programs and training.
Arent Fox also assists Hospitals, Health Care Systems, and free-standing Home Health Agencies in establishing appropriate corporate ownership structures and relationships that maximize new service capabilities and revenue potential. These projects include personal care companies, home infusion partnerships, private duty nursing companies, and management companies. In the area of professional services agreements, management agreements, and joint ventures, Arent Fox has assisted numerous HHAs in constructing or analyzing relationships to minimize the legal risks of failure to comply with state and Federal anti-kickback statutes and Stark laws prohibiting certain physician referrals.
Hospices and Palliative Care
The Arent Fox Health Care practice group is a leading provider of legal services to Hospices and Palliative Care Programs throughout the United States. We advise them on a broad array of matters, including regulatory advice, fraud and abuse issues (e.g., anti-kickback statute, Stark Law, False Claims Act, exclusions), audits, investigations, surveys, reimbursement, contracts, compliance programs, training, corporate structuring, transactions, administrative appeals, state and Federal litigation, government relations, HIPAA and HITECH, and managed care relationships. We represent Hospices and Palliative Care Programs on licensure, certification, coverage and billing issues; conduct internal investigations; defend against Federal and state investigations and audits, involving the Department of Justice, state Departments of Health, the Office of the Inspector General, state Offices of Medicaid Inspector Generals, Medicaid Fraud Control Units, Zone Program Integrity Contractors, Medicaid Integrity Contractors, Recovery Audit Contractors; respond to survey and certification or accreditation deficiencies; and act as general counsel, including labor and employment matters. We conduct compliance audits and implement compliance programs and training. We advise providers on how to establish different types of Palliative Care Programs, and comply with a complex and ever-changing regulatory landscape.
Arent Fox is on the forefront of the palliative care initiative, working with state and Federal regulators in an effort to lobby for changes in laws and regulations. We were instrumental in New York State’s amending its Hospice licensure law to include Palliative Care Programs. Arent Fox partners have served on the Regulatory and Public Policy Committees of the National Hospice and Palliative Care Organization (NHPCO), and have worked with the Center to Advance Palliative Care (CAPC).
Litigation & Alternative Dispute Resolution
Our health care litigators represent clients before administrative and judicial forums dealing with survey and certification appeals, coverage and reimbursement appeals, and individual and institutional licensure hearings. We also litigate a broad range of business disputes for our health care clients, including contract disputes, actions to enforce noncompetition agreements and employment actions. Arent Fox litigators are skilled in the arts of advocacy and informal dispute resolution, and our team of trial lawyers has won verdicts in state and federal courts throughout the country. We also have an active appellate practice and have successfully argued cases before state and federal appellate courts and the US Supreme Court.
Arent Fox has a multidisciplinary taskforce to help clients navigate all phases of electronic discovery while minimizing risk and cost. Our attorneys work with clients to design and implement comprehensive litigation response plans that include: pre-litigation risk assessments; preparation and implementation of litigation holds and protocols designed to control the costs associated with identification, collection, and storage of data; implementation of methods for the efficient identification and preservation of evidence; supervision of crisp data collection; review and production procedures; and strategies to protect the attorney-client privilege.
Medical Staff Credentialing & Peer Review Law
As members of a profession, physicians and other health care providers have long embraced an obligation to not only provide care that meets professional standards, but to evaluate and, if necessary, take steps to improve the practices of colleagues. These professional undertakings provide the foundation for the credentialing, peer review, and quality improvement programs that are at the core of the modern medical staffing.
As a result of ever more demanding legal and accreditation standards, medical staffs have been assigned even more responsibility for — and are more accountable to — rigorous credentialing, meaningful peer review, and continuous steps toward quality improvement.
Arent Fox attorneys are known for their broad experience guiding hospital medical staffs. We have advised on questions of:
- Medical staff organization
- Governance and leadership
- Bylaws, rules, and policies
- Peer review
- Investigations and formal hearings
- Appellate reviews
- Practitioner well-being and behavior
- Allied health professionals
- Standards of the Joint Commission on Accreditation of Health Care Organizations
Our team has extensive experience in providing key advice and representation to the medical staff leaders in formal hearings and subsequent governing body appellate reviews, and we have been counsel of record in a number of precedent-setting appellate court decisions. Our experience and background allow us to educate medical staff about their rights and responsibilities, and thereby assist them in reaching the “quality of care” goals that are vitally important to physicians, hospitals, and patients.
Physician Employment and Contracting
The experience we have gained through advising hospitals and medical staffs has positioned us to provide the necessary guidance for medical group employment, physician contracting, accountable care organizations, physician practice in ambulatory care settings, and numerous other comparable new practice arrangements.
As society and the legal system have come to appreciate the importance of the physician’s access to practice settings outside hospital medical staff, the courts, accreditation agencies, and other powerful organizations have extended the requirements of fair procedure and due process to the credentialing and peer review activities of these other entities.
Further, as society transitions from traditional fee-for-service and reimbursement models to various at risk and pay-for-performance schemes, effective health care provider credentialing and peer review not only remain ethically important, but become the keys to medical group, surgery center, and accountable care organization (ACO) sustainability.
In assisting provider groups to create employment relationships or other contracting models, we draw upon our experience in the practice of law as well as our decades of close, collegial working relationships with physicians. We guide groups as they both acknowledge the newer requirements of employment and other contracting relationships, while retaining all that is worthy in traditional physician credentialing and peer review programs.
Patient Safety Organizations
With increased interest in patient safety, laws have developed both at the federal and the state level regarding reporting, aggregating, analyzing, disclosing and protecting information regarding adverse events, near misses and other patient safety concerns. Building on its strong track record of advising clients regarding clinical operational and patient safety issues generally, Arent Fox has developed significant expertise in patient safety evaluation systems (PSES) and protecting patient safety work product (PSWP). This includes assisting hospitals and other providers in setting up a PSES, reporting to a patient safety organization (PSO) and protecting or disclosing PSWP as appropriate. Arent Fox attorneys also have extensive experience in analyzing clinical patient safety incidents, and we regularly assist clients with effectively reporting and responding to information requests from state licensing entities and accreditation bodies regarding such incidents.
Payer Disputes & Reimbursement
Arent Fox draws experience from its leading Health Care and Litigation practice groups to provide both a deep and broad understanding of the industry and the specialized know-how to get payer disputes and reimbursement issues resolved.
Our substantive experience runs the gamut from ERISA, COBRA, FEHB, HIPAA, ACA, state insurance laws, Medicare Advantage, and the MSP Act, to federal and state health care regulatory law. Our group also boasts a roster of talented litigators whose strategic capabilities enable us to steer matters through all forums of dispute resolution in order to successfully achieve our clients’ goals. Our team of seasoned lawyers is complemented by non-lawyer specialists with billing, coding, and coverage skills. Additionally, our proprietary case management system developed specifically for this practice allows us to funnel and track large case volumes with efficiency, while providing the highest level of client service and attention to detail.
A large portion of our work in this area involves the representation of health care providers in disputes with commercial payers, where we have recovered millions of dollars for our clients. The matters we regularly handle include out-of-network reimbursement disputes, managed care contracting disputes, federal preemption issues, coverage disputes, coordination of benefits issues, network and preferred provider disputes, single patient agreement breaches, repricer challenges, “usual, customary, and reasonable” calculations, and recoupment demands.
We routinely handle administrative claims and appeals under ERISA, as well as through the Office of Personnel Management. In court, we pursue both state law provider claims and ERISA assignee-based claims. We recently prevailed in a case for one of our clients in which we asserted ERISA claims for fiduciary breaches and benefits, and ultimately obtained reimbursement at nearly 100% of billed charges, plus an award of attorneys’ fees.
Other engagements on behalf of health care providers have included:
- ERISA administrative claims and appeals challenging benefit denials.
- Pursuing OPM and FOIA claims with respect to FEHB Plan disputes.
- Negotiating with plan sponsors with respect to alleged illegal plan terms.
- Enforcing commercial insurer contractual compliance with preferred provider network arrangements and treatment agreements.
- Challenging audit findings, overpayment demands, and recoupment actions issued by third-party administrators, insurers, and health plans.
- Representing providers in disputes with large insurers, including terminations of provider agreements.
- Challenging plan fiduciaries for failure to follow proper claims and appeals procedures.
- Counseling providers on out-of-network “usual, customary, and reasonable” ERISA class action litigation.
- Drafting and providing counseling with respect to insurance verification, intake, and assignment of benefits documentation.
- Challenging commercial payers who violate the MSP Act and other coordination of benefits rules.
- Representing out-of-network providers in reimbursement disputes with self-insured and insured health plans.
Our attorneys also regularly advise our clients on a vast array of areas that impact managed care relationships. We provide guidance on benefit plan interpretation and requirements, and assist clients in negotiating issues such as withhold pools, filing grievances regarding “slow pay,” “down-coding,” and other allegations against commercial payers with state insurance departments, and developing shared risk agreements with physician-hospital organizations and others.
In addition, our Health Care attorneys regularly guide clients through issues related to overpayments by Medicare, Medicaid, and other government payers. These issues can take many forms, including responding to audits and inquiries by the Office of Inspector General (OIG) or any of a number of government contractors tasked with identifying and recovering funds paid to providers. For providers and suppliers, the acronyms can be disorienting: Recovery Audit Contractors (RACs), Zone Program Integrity Contractors (ZPICs), Medicare Administrative Contracts (MACs), Medicaid Integrity Contractors (MICs), Medicaid Fraud Control Units (MFCU). Arent Fox attorneys can bring some clarity to the regulatory alphabet soup, assisting clients with responding to audit requests and inquiries and, where appropriate, and challenging overpayment determinations through administrative appeals.
Following enactment of the Patient Protection and Affordable Care Act (PPACA), providers now have an affirmative obligation to self-report and repay Medicare and Medicaid overpayments within 60 days of identifying an overpayment. Arent Fox attorneys frequently assist clients in determining when a compliance failure creates overpayment liability, assessing the scope of potential overpayment liability and making disclosures to the appropriate government entity.
Pharmaceutical & Device Compliance
The pharmaceutical and medical device industries are increasingly subject to intense government scrutiny. Arent Fox helps these companies navigate the rough waters by providing fraud and abuse risk assessments related to the sales and marketing of prescription drugs and medical devices under both federal and state fraud and abuse laws, as well as compliance program development, monitoring, auditing, and training tailored for the drug and device arena. We assist with “Sunshine Act” compliance, both under the federal Physician Sunshine Act and under state laws mandating reporting of advertising and marketing costs. We counsel companies related to all forms of patient assistance programs, including free goods, charities, and manufacturer-sponsored “coupon” or co-payment assistance programs. We also track state law developments relating to price reporting, registering of clinical trials and reporting of trial results, limitations on prescription data-mining and licensing or other oversight of field sales representations.
Prescription Drug Pricing & Government Price Reporting
Arent Fox is one of only a handful of US firms that can provide sophisticated counsel to the prescription drug industry on the full range of complex pricing issues, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program, and non-FAMP and FCP reporting to FA/FSS. We also assist pharmaceutical manufacturers in navigating the Coverage Gap Discount Program under Medicare Part D, NADAC, and the AAC methodologies currently being adopted by state Medicaid programs. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with CMS, the Office of Pharmacy Affairs at HRSA and the VA, and representing clients facing enforcement actions tied to their price reporting obligations.
Product Coverage & Payment
The successful launch and sale of a health care product or service depends largely on the availability of adequate Medicare, Medicaid, and third-party payer coverage and reimbursement. Whether a product or service is a state-of-the-art emerging technology or considered an established standard of care, Arent Fox attorneys have the experience to develop and implement local and national strategies to champion new reimbursement and to address existing coverage and payment inequities. We work with clients to ensure that clinical trials are designed to collect data critical to address the safety and efficacy standards for FDA approval as well as the medical necessity standards of payers. We also assist clients determine the most advantageous regulatory approval strategy to position a product for third-party reimbursement.
Telemedicine & E-health
The use and sharing of electronic medical records, the transmission of health care information by electronic communications, and E-health are some of the hottest issues in health care today. With the enactment of the HITECH Act on the federal side and numerous initiatives at the state level, all health care providers will need to use electronic medical records over the next few years. Arent Fox has a long history as a leader in this area, frequently assisting clients in licensing, contracting, advertising, fraud and abuse, reimbursement, and privacy issues that arise in the E-health world.
Transactions & Regulatory Due Diligence
Our attorneys have significant experience in the structuring and closing of complex corporate transactions in the health care industry. In recent years, we have completed several hundred M&A transactions with multistate providers of health care services.
At Arent Fox, we provide a multidisciplinary team-approach to address all aspects of contract negotiations and transactions, including tax, antitrust, bond financing, labor and employment, benefits, regulatory compliance, government approvals, and real estate. Our experience enables us to identify quickly key business and regulatory issues and facilitate the development of appropriate legal structures for a targeted transaction or relationship. We represent numerous health care entities in mergers, acquisitions, divestitures, and joint ventures. We have vast experience advising clients on how to structure these arrangements to comply with the Anti-kickback Statute, the Stark Law, the False Claims Act, and other federal and state laws governing relationships among health care providers.
We also represent private equity funds and other sources of equity to the health care industry, as well as lenders to public and private businesses that operate skilled nursing, assisted living, continuing care, and retirement and independent living facilities. We represent buyers and sellers of nursing homes, assisted living and independent living facilities, and a variety of ancillary service businesses in hundreds of transactions throughout the country. Our attorneys have years of experience in starting, financing, and growing early stage, venture-backed health care companies. We also advise clients on the regulatory and transactional legal issues faced by companies during accelerating growth.
Our goal in negotiating contracts and transactions is to understand and help our clients reach their business goals while remaining sensitive to compliance with federal fraud and abuse laws, Medicare conditions of participation, and state licensing requirements. For our pharmaceutical and medical device clients, we also handle contracting and other interactions with wholesales, managed care organizations, pharmacy benefits managers, Medicare and Medicare Part D plans, and patient assistance foundations.
In addition, our team conducts health care regulatory due diligence for merger, acquisition, and financing transactions. For acquiring companies, venture capital firms, lenders, and underwriters, we put our regulatory knowledge and extensive investigative experience to work in assessing target companies in a health care context. We look at issues such as licensure, certification, coverage and reimbursement, billing and coding, marketing, and financial relationships with physicians and other referral sources (anti-kickback and Stark law compliance) to evaluate a target’s compliance with applicable laws, rules, and regulations. We identify and assess a target’s regulatory risks and communicate them to clients.
Contracts are everywhere in the health care industry. Our attorneys also have significant experience in the structuring, negotiating, drafting, reviewing, and closing of contracts that arise in the context of health care transactions, vendor arrangements, physician employment, and independent contractor arrangements, managed care, joint ventures, and many other areas. In recent years, we have completed several hundred M&A transactions with multistate providers of health care services.
Wholesaler & Pharmacy Benefits Compliance
Entities within the pharmaceutical supply chain, including pharmacies, wholesalers and pharmacy benefit managers, face many regulatory, reimbursement and compliance challenges. In addition, they must deal with commercial and operational challenges within pharmaceutical distribution networks.
Arent Fox helps these companies navigate these challenges by providing:
- Fraud and abuse assessments and counseling
- Advocacy to FDA, CMS, and state agencies involving regulatory proposals that may significantly impact pharmacy and pharmacy benefit operations
- Compliance program design and implementation
- Negotiation of rebates agreements, in-network pharmacy provider agreements, and pharmacy benefit management services agreements
- Counsel on commercial and statutory pricing issues, including Average Wholesale Price, Maximum Allowable Cost methodologies, Actual Acquisition Cost, National Average Drug Acquisition Cost, Medicaid Drug Rebate Program, and the Federal Upper Limit
- Assistance with formulary development and plan design in accordance with Medicare Part D, the Affordable Care Act, and state statutory and regulatory requirements
- Counsel on therapeutic interchanges in long-term-care facilities and otherwise
- Consultation on the development of medication therapy management or patient adherence programs and the legal and compliance implications that are associated
- Assistance in the design of generic substitution and drug utilization management programs
- Assistance with pharmacy licensure, third party administrator, and utilization review agency licensure
- Counsel on e-prescribing requirements
- Counsel on 340B program administration and requirements
- Advise on FDA, FTC, and state regulatory compliance for private label products
- Counsel on state licensure issues
- Defense of enforcement actions initiated by state Boards of Pharmacy
Medicare Part D
Arent Fox advises and counsels pharmaceutical manufacturers, pharmacy benefit managers, pharmacies, and others in the pharmaceutical supply chain on a wide range of complex legal, regulatory, and legislative issues, many of which stem from the Medicare Prescription Drug Improvement and Modernization Act of 2003. Our advice extends to various program requirements, including:
- Fraud, waste and abuse
- Compliance Program development
- Plan design and formulary development
- Marketing practices
- Relationships with first tier, downstream, and related entities
- Beneficiary rights and safeguards, such as appeals and grievances
- The Coverage Gap Discount Program
- Development and implementation of corrective action plans
We advocate on behalf of our clients before CMS and help clients prepare for and respond to CMS and OIG audits and inquiries.