The complex web of regulatory and compliance requirements placed upon healthcare providers, practitioners, payers, and suppliers continues to significantly affect the industry on the whole. Because it can be overwhelming to comprehend the full impact of these requirements, you need counsel who understands the unique regulatory regimes that apply to both healthcare providers and government contractors.
Drawing on substantial government and industry experience, our team of healthcare attorneys and policy advisers are nationally recognized for providing compliance and enforcement representation to healthcare providers and companies in federal and state healthcare matters. We provide you with strategic advice on public policy, legislative issues, and business development, as well as on a broad range of regulatory activities, including rulemaking, interpreting regulations, and compliance efforts.
To keep you apprised of the latest developments, we actively monitor regulatory agencies, including implementation of legislation and changes of agency rules and regulations. Our relationships with regulators allow us to proactively meet your needs while preserving the integrity necessary to continue to do business with strategic government partners in the future.
How We Can Help
Blank Rome’s attorneys and advisers have guided healthcare clients in the following areas:
- Structuring of arrangements for compliance with the Stark Law, the federal Anti-kickback Statute, and the federal False Claims Act
- Compliance with increasingly complex healthcare privacy and security requirements (EU- and U.S.-based multi-national corporations)
- Provider (institutional) and supplier (individual) licensing activities
- Agency hearings, medical board inquiries, and tribunal representation
- Drafting comprehensive compliance policies and guidance documents
- Prepayment and post-payment audits and investigations before federal and state regulatory agencies, Medicare and Medicaid Administrative Contractors, and other government auditors and contractors
- Clinical research compliance, including informed consent documents, and storage and use of human biological samples
- Sarbanes-Oxley compliance
- Tax-exempt compliance
The healthcare policy and compliance team regularly interacts with various state and federal agencies such as the U.S. Department of Health and Human Services (“HHS”), including its principal operating components, the Centers for Medicare and Medicaid Services (“CMS”), the Office of Inspector General (“OIG”), the Food and Drug Administration (“FDA”), and the components that comprise the Secretary’s Office, such as the Office of General Counsel.
What Sets Us Apart
- Our attorneys have served on the National Governor’s Association and Joint Committee, and the Pennsylvania Joint State Government Commission (“JSGA”) Advisory Committee to review public health laws, as well as commissions such as the Long-Term Care Work Group of the Governor of Virginia’s Health Reform Commission and the current Governor’s Health Care Transition Team.
- We were one of only 20 government contracts practices ranked nationally in 2018 Chambers USA, where editors praised us for our “depth and breadth of expertise in the government area” and for serving as “good business and legal advisers in the government law arena.”