For more than two decades Wiley Rein attorneys have represented health plans, health care providers, pharmaceutical companies and other health-related entities in connection with federal and state health care programs, as well as with the application of federal law to commercial health businesses. Our engagements have ranged from health care procurement and contract administration, to regulatory counseling, to the defense of false claims allegations and the prosecution of those who defraud our clients. Many of our clients are contractors under the Medicare, Medicaid, Federal Employees Health Benefits (FEHB) and the U.S. Department of Defense (DOD) TRICARE programs. As Washington lawyers, we offer an uncommon depth and breadth of regulatory experience and understanding of the myriad laws and regulations governing these programs.
Federal and State Health Care Programs: Procurement and Regulatory Counseling | Commercial Health Care Programs and Regulatory Counseling | Health Care Transactions | Health Care Fraud and Corporate Compliance | Privacy | Health Care/FDA | Contact Us
Federal and State Health Care Programs: Procurement and Regulatory Counseling
We handle the full spectrum of matters relating to the procurement of health care, from the solicitation of requests for proposals to defending awards, filing protests, and counseling on contract administration matters. Our lawyers negotiate and draft contracts with government agencies, subcontractors, and vendors, including pharmacy benefit managers and behavioral health companies. With contracts in place, we represent our clients in cost report and contractor performance audits and contest audit findings at the administrative level, before the Armed Services Board of Contract Appeals (ASBCA), and in federal court. We also represent our clients in government surveys and investigations and defend them in false claims investigations, litigation, and other program integrity-related proceedings.
Our work under the Medicare program has been extensive, and our clients have been in the forefront of Medicare reform. They are fiscal intermediaries, carriers, and providers across the country. We have represented them on many procurement and regulatory matters, including those that have addressed issues in the following areas:
- Contract amendment, transfer, and termination
- Program operations and certifications
- Compliance with state and federal privacy laws and the Health Insurance Portability and Accountability Act (HIPAA) Standards for Electronic Transactions
- Contractor budgeting and budget performance
- Contractor reimbursement (allowability) and allocation of costs
- Fiscal intermediary and carrier payment safeguards
- Provider audit and reimbursement activities
- Internal investigations
- System Tracking for Audit and Reimbursement (STAR) and Contractor Performance Evaluation Program (CPEP) reporting
- Contractor Performance Evaluation (CPE) audits and Chief Financial Officers Act of 1990 (CFO) reviews
- Corrective action plans
- Medicare secondary payer
- Alleged kickbacks and Stark self-referrals
- Provider overpayments
- Appeals before the Provider Reimbursement Review Board
- Corporate mergers, acquisitions, reorganizations, and bankruptcies
- Successor liability
- Pension plan contributions and plan terminations
- Medicare reform, including participation in new programs authorized by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, in particular contractor reform, Medicare Advantage and Part D
We have broad Medicaid procurement experience for both managed care companies and providers. We negotiate contracts between managed care plans and state Medicaid offices, health plans and pharmacy benefit managers, and between providers and management service companies. Our lawyers also counsel our clients on maintaining contract and program compliance. We have worked on a wide range of matters and issues addressing:
- Contract negotiation with federal and state agencies
- Bid protests and related litigation
- Provider licensure requirements
- Provider audit and reimbursement
- Provider surveys and program certification
- Statements of deficiencies and plans of correction
- Quality of care
- Network development, provider contracting, and provider reimbursement on behalf of health plans
- State waiver program requirements
- Procurement of pharmacy benefits and related management services
- Compliance with state and federal privacy laws and the HIPAA Standards for Electronic Transactions
- Corporate reorganizations, mergers, and asset sales
- Internal investigations
- Government investigations
- State waiver program requirements
Federal Employees Health Benefits Program
We serve as outside counsel to a major carrier association participating in the FEHB Program. In that capacity, we have participated in contract negotiations between the association and the U.S. Office of Personnel Management (OPM) and subcontractors in the drafting of the member brochure and in day-to-day contract compliance issues. We also represent this association in its contract negotiations with retail and mail service pharmacy benefit management (PBM) vendors and in related pharmacy benefits matters arising under those contracts. Finally, we have assisted community-rated plans with entry into the FEHB Program with preparation of benefit package proposals, annual rate submissions, and with rate reconciliation matters. More specifically, we have provided counsel on regulatory issues under the FEHB Program that has addressed:
- Cost principles under the Federal Acquisition Regulation (FAR) Part 31
- Subcontracting obligations under the FAR
- Pharmacy benefits
- Member benefit design
- OPM cost report audits
- Coordination of benefits and subrogation
- Affiliate transactions
- Vendor agreements and joint ventures
- Compliance with the state and federal privacy laws and the HIPAA Standards for Electronic Transactions
- Preemption of state law
- Patients’ Bill of Rights
- Denial of benefits and related litigation
In addition, on behalf of our FEHB Program clients, we have successfully appealed final OPM audit decisions to the ASBCA that raised issues of unallowable costs, defective pricing, defective community rating, improper loadings, lost investment income, and federal subcontracting obligations.
We provide counseling and litigation services to TRICARE contractors on pre-award, bid protest, and procurement issues. Our lawyers have brought and defended bid protests and handled related litigation. We also have a well-established practice assisting TRICARE contractors after contract award. Given the government’s historic propensity to modify contracts, either constructively or through change orders that fail to include adequate financial adjustments, we have developed an active practice representing clients in the preparation and negotiation of requests for equitable adjustments (REA) and claims against the government.
Commercial Health Care Programs and Regulatory Counseling
Our representation of health care entities extends to providing counsel and advice on a wide array of statutory, regulatory, and general compliance issues affecting commercial health care products. In this regard we have:
- Represented health care companies in regulatory matters arising under state law (including preparing licensure applications and providing representation in regulatory audits).
- Provided counsel on the application of federal law and regulation, including the Employee Retirement Income Security Act (ERISA) (e.g., concerning access and portability issues arising under Title I) and corresponding U.S. Department of Labor (DOL) regulations.
- Developed and negotiated administrative service organization (ASO) contracts, full and partial risk contracts for commercial products, and contracts for pharmacy benefit management services.
- Provided extensive analyses of state laws and pending legislation affecting commercial plans, including providing advice regarding the extent to which such laws might be preempted under applicable federal requirements.
Health Care Transactions
We counsel providers, insurers, and other law firms on the regulatory requirements (including reporting, disclosure, and licensure obligations) arising out of corporate reorganizations, mergers and acquisitions, and bankruptcies of health care businesses. In providing this advice, we often work as a team with our colleagues in the firm’s Corporate Practice, reviewing and drafting agreements and undertaking specific due diligence assignments. We also provide counsel on related issues addressing successor liability, indemnification, document retention, government reimbursement of related transaction costs, and ongoing provider services and post-transaction cooperation of the parties.
Health Care Fraud and Corporate Compliance
Health care fraud enforcement continues to be a top priority of the U.S. Department of Justice (DOJ) and a variety of other state and federal law enforcement organizations. Coupled with this priority status is an enhanced set of resources, including hundreds of new health care fraud prosecutors and investigators and new enforcement tools, such as the federal crime of health care fraud, asset forfeiture remedies, and stricter civil, criminal, and administrative penalties.
Our attorneys have represented health care entities in a wide variety of health care fraud matters, including representing health insurers that have been defrauded by health care providers. In this regard, we have worked closely with law enforcement officials around the country on joint investigations and are able to provide a unique insight into the government’s enforcement activity in terms of how they work and where their priorities lie. Because of this work, we have a unique perspective when asked to assist health care clients, whether health insurers or health care providers, in the defense of government fraud investigations or qui tam suits. Our recent anti-fraud-related matters have included:
- Representation of groups of health insurers in major national Racketeer Influenced and Corrupt Organizations Act (RICO), ERISA, and state-law-based insurance fraud suits and investigations involving health care fraud by psychiatric hospitals, home care providers, rehabilitation hospitals, clinical laboratories, dialysis companies, and dental groups.
- Representation of property/casualty insurers in RICO and fraud litigation against chiropractic clinics, medical mills, and personal injury attorneys.
- Representation of insurers in smaller cases involving fraudulent activities by individual physicians and insureds.
- Representation of insurer victims in criminal RICO cases.
- Defense of malicious prosecution, defamation, and invasion of privacy suits around the country.
- Evaluation of national RICO suits against various health care providers, attorneys, and other insurance claimants.
- Filing of amicus curiae briefs before the Supreme Court, lower federal courts, and state supreme courts, on restitution, waiver of copayment, victim participation, and other fraud-related issues.
We also have extensive experience defending health care providers and insurers accused of fraudulent conduct including the following representative engagements:
- On behalf of a major carrier that underwrote group health benefits for the FEHB Program, we won the dismissal of the relators (former inspector general auditors) in a $30 million qui tam suit filed under the False Claims Act (FCA).
- We also successfully defended a $100 million class-action fraud suit brought against a carrier that involved provider discount, coinsurance, and civil RICO issues.
- We have successfully defended numerous Medicare fiscal intermediaries and other health care contractors in false claims investigations, resolving the matters before litigation ensued or the government intervened in a qui tam suit. One parallel criminal and civil investigation involved allegations of provider overpayments and the submission of false Medicare cost reports and false certifications to the government. Another dealt with allegations of fraudulent reporting of contractor performance under Medicare secondary payer regulations.
- In conjunction with the global settlement of a false claims investigation, we negotiated the first corporate integrity agreement (CIA) for the Medicare+Choice program.
- In many of these representations, we have advised and guided health care contractors through issues pertaining to voluntary self-disclosure, debarment and exclusion, the negotiation and amendment of CIAs, CIA violations and material deficiencies, and contract termination, transfer, and novation.
We have drawn upon these experiences in leading compliance reviews and audits at numerous health care companies in which we have implemented or updated existing compliance programs and designed interactive compliance training modules for company employees. We tailor each compliance program to the specific operations and business culture of the client to facilitate its becoming an integral part of each employee’s day. When necessary we have assisted clients in undertaking internal investigations into allegations of fraud or wrongdoing and have helped them successfully navigate the intricacies of a government investigation.
Many of our lawyers bring to our Health Care Practice valuable insight gained while employed by the government. That experience includes the investigation and litigation of major health care fraud cases on behalf of U.S. Attorneys’ offices and service on the DOJ's Health Care Fraud Working Group. In that capacity, our lawyers prosecuted allegations of fraud and regulatory noncompliance and reviewed model compliance programs. Those experiences offer our clients an important perspective when they must defend fraud cases or conduct internal investigations.
Insurers and providers have been directly or indirectly at the heart of most of the visible public debate on privacy. As part of the financial services industry, insurers recently faced compliance obligations related to the first national statute regulating privacy across an industry, the Gramm-Leach-Bliley Act (GLBA). The health care industry as a whole now faces enormously complicated privacy requirements stemming from HIPAA. With the advent of e-commerce and the increasing globalization of the insurance marketplace, insurers and many providers also must master Internet privacy rules and the increasingly complex international privacy environment. In our work for the health care industry, we have focused attention on all aspects of the privacy debate as it affects the industry. This integrated privacy effort has allowed us to understand and analyze the broad public policy debate on privacy, and to advise our clients both on the rules as they stand today and where they likely will be moving in the future. Wiley Rein is nationally ranked as a top-tier firm in the Privacy & Data Security: Healthcare category by Chambers USA (2010). The directory’s sources single out Kirk J. Nahra, the firm’s Privacy chair and Health Care co-chair who has consistently been ranked as a top-tier privacy attorney by Chambers USA (2010-2013), as “an expert on HIPAA and other healthcare-related governed by privacy laws” who “brings more than just his tremendous knowledge of current data privacy and security law—he also brings practical knowledge of what other healthcare organizations are doing.” Mr. Nahra is rated as one of “The Best Lawyers in America” in the area of Health Care Law as well.
We are assisting numerous companies in meeting their immediate compliance obligations under the GLBA, the HIPAA Privacy Rule, and the HIPAA Standards for Electronic Transactions. For both insurers and providers we are:
- Conducting privacy audits.
- Advising on critical strategic and compliance issues arising from the GLBA and HIPAA.
- Evaluating business options for meeting privacy challenges.
- Drafting privacy forms and notices, including consent forms, authorization forms, and business associate and trading partner agreements.
- Providing risk management and litigation advice.
- Identifying state privacy laws and performing HIPAA preemption analyses.
In addition to projects for clients, we have been at the forefront of the effort to alert insurers and providers to these issues and to educate the health care industry on the compliance and implementation challenges associated with this developing area. As part of these education and awareness efforts, we publish and speak regularly to a wide variety of audiences on privacy issues both inside and outside the health care industry. With more than a dozen partners with significant privacy expertise, we have one of the most complete privacy practices in the country.
Our firm’s Food & Drug Law Practice offers a full range of regulatory and litigation services to manufacturers of pharmaceuticals, medical devices, foods, and other consumer products. In areas where health care and U.S. Food and Drug Administration (FDA) concerns intersect, we have addressed:
- Health fraud, antitrust, and reimbursement issues arising from business relationships with pharmacy benefit managers.
- FDA and health fraud issues arising from promotional practices involving pharmaceutical companies, PBMs, pharmacists, doctors, and health maintenance organizations.
- Antitrust ramifications of alliances between sectors of the health care industry.
- Reimbursement and rebate issues under Medicare, Medicaid and the Veterans Health Care Act, addressing Average Wholesale Price (AWP), Average Manufacturer Price (AMP), Best Price, Most Favored Customer (MFC) Price, and the Federal Supply Schedule.
- Creation of, or relations with, disease management entities.
- Due diligence for acquisition and mergers of pharmaceutical companies.
- Structuring transactions involving other sectors of the health care industry to comply with requirements of the anti-kickback, self-referral, antitrust, and FDA laws and regulations.
ISSUE: FEBRUARY 2015
IN THIS ISSUE
- Why the 114th Congress Will Not Be Business as Usual for Data and Cybersecurity Legislation
- President Obama Issues Executive Order on Information Sharing; Reiterates Needed Attention to Privacy
- President Obama Issues Presidential Memorandum on UAS Privacy
- Summary of NPRM on Operation and Certification of Small Unmanned Aircraft Systems
- Team Member Spotlight: Shawn H. Chang
- Speeches & Events
Lessons to Be Learned from the Sony Breach
By Kirk J. Nahra
March 2015 | ABA Corporate Compliance Committee Newsletter
Privacy, Research and the Evolution of Health Care in the 21st Century
By Kirk J. Nahra
March 18, 2015 | Bloomberg BNA's Medical Research Law & Policy Report
Round Up of Notable Medicare Reporting and Reimbursement Developments for Property and Casualty Insurers
By Kathryn Bucher, Laura A. Foggan, Richard L. McConnell, Edward R. Brown and Frederick H. Schutt
February 13, 2015
RECENT NEWSKirk Nahra Discusses U.S. House Data Security and Breach Notification Draft Bill
March 18, 2015
Kirk Nahra Featured in Bloomberg BNA Webinar on Top Health Privacy and Security Issues of 2015
March 12, 2015
CMS Final Rule Establishing Right of Appeal for Medicare Secondary Payer Determinations Raises Important Issues for Liability Insurers
March 6, 2015