Health Care Regulatory
In a constantly changing health care regulatory environment, health care providers, vendors, service providers, and investors need a team that will put them in their best position to take advantage of regulatory opportunities and avoid or successfully defend regulatory violations. We work with our clients to develop strategies to identify and maximize opportunities, manage risks, and comport with government policies and considerations. Our team can work collaboratively with your team to ensure compliance with the ever-changing complex federal and state regulations covering Medicare and Medicaid, fraud and abuse, payment and reimbursement, licensure, accreditation and certification, HIPAA privacy and confidentiality, and more.
Compliance and Operations
In virtually every aspect of the industry, our team provides sophisticated counsel on health care compliance matters, including Medicare and Medicaid regulatory compliance; hospital, physician, and every other type of care provider payment and reimbursement; day-to-day operational compliance; value-based care; EMTALA; facility survey and accreditation responses; HIPAA privacy and security; No Surprises Act (NSA) compliance; and provider enrollment and credentialing. Our health care practice lawyers are well-versed in the design/assessment of appropriate infrastructure, development of written policies and procedures, development of compliance training, and the design and implementation of monitoring and reporting systems. We also have significant experience in internal investigations, self-disclosures, negotiation and implementation of corporate integrity agreements, and resolving identified overpayments with various payers including the federal health care programs. We are often asked to conduct transactional due diligence and assessment of regulatory risk of a target entity, where our deep and broad experience can quickly provide an accurate risk picture for investors and acquirers alike.
With one of the most sophisticated reimbursement practices in the country, we are dedicated to assisting clients with reimbursement strategies, reimbursement litigation (including audit appeals and dispute resolution), and managed care contracting issues. We identify creative options to maximize revenue streams, respond to changes in the state or federal environment, and challenge reimbursement cuts and audit disallowances. We also routinely advise clients on dealing with identified overpayments and address enforcement risks implicated by those overpayments.
The ability to anticipate, understand, and respond to the complex and changing rules of payers, including the Medicare and Medicaid programs, is crucial. Our team has extensive industry and government experience in Medicare Parts A, B, C, and D; Medicaid; commercial reimbursement; research payments; and the fraud and abuse issues associated with reimbursement rules. We work daily with hospitals, facilities, institutions, suppliers, and providers on questions relating to billing processes, enrollment, credentialing/licensing issues, claims appeals, and related matters.
We keep ahead of new developments in the Medicare and Medicaid arena because of our daily national work with stakeholders across the health care industry, our leadership roles in health law professional associations, and our tracking of trends in the innovative work we do for our clients across the industry and across the country. We keep our clients informed with regular blogs and podcasts on current health care issues, available at healthcarelawtoday.com.
Fraud and Abuse
Our deep experience with the governmental payer requirements, the federal anti-kickback statute, the Stark Law, the Civil Monetary Penalties Law, EKRA, and various similar state provisions allows us to work with our clients to design effective compliance and audit programs, as well as structure compliant business arrangements. Where defense or disclosure is necessary, our attorneys have positive relationships with many government agents and attorneys to facilitate such discussions and present. We work in tandem with our Government Enforcement colleagues to defend against allegations of false claims act violations. Our strong understanding of the applicable reimbursement framework provides us with unique insights into the intricacies of these analyses.
- Represented hospitals and physician practices in self-disclosures to the Centers for Medicare and Medicaid Services related to Federal Physician Self-referral (Stark) Law violations.
- Represented DME and orthotics companies in the development of their compliance programs (policies and training), advice regarding client contracting, and sales agent contracting issues.
- Served as compliance effectiveness review expert for OIG Corporate Integrity Agreement.
- Represented one of the largest global private equity firms in connection with its acquisition of a health care information technology service, including regulatory, fraud and abuse, and reimbursement related services in the United States.
- Advised public hospitals regarding affiliation strategies with potential hospital and clinic partners and related regulatory issues in the context of federal and state Medicaid financing and payment requirements. Our advice included payments analysis, legislation involving the creation and possible implementation of a standalone hospital authority, physician-hospital organization strategies, delivery organization and financing, and antitrust.
- Counsel to multiple entities setting up COVID-19 testing for employers, sports teams, schools/universities, and freestanding or temporary site laboratories, now including audits and investigations relating to the receipt of governmental funding.
- Represented defendant clinical laboratory in government investigation of sales, billing, and collection practices.