Healthcare Regulatory Compliance

At Healthwise Legal, we know how to guide national healthcare companies, as well as local medical practices and healthcare ventures, on difficult corporate practice of medicine issues.

The corporate practice of medicine doctrine prohibits a corporation from practicing medicine. This derives from the statutory prohibition against the unlicensed practice of medicine. However, the extent of the prohibition differs from state to state. This can make it difficult for healthcare companies offering national services, to navigate expansion and operations across the country.

We understand the different collaborations that can exist between physicians and non-physicians both locally and across the country, to ensure both parties can mitigate risk and move forward in a venture with confidence and ease.

We advise on the many intricacies of both state and federal self-referral, anti-kickback and fee-splitting prohibitions and help our clients navigate the numerous ways these prohibitions may affect their business.

Given the significant penalties that can ensue from a violation of fraud and abuse laws, we carefully analyze statutes, Office of the Inspector General (OIG) advisory opinions, judicial opinions, policy statements, and safe harbors to ensure our clients understand the clear boundaries surrounding their ventures while creatively finding innovative ways to move forward.

These laws include:

• Stark law

• State self-referral laws (such as California’s Physician Ownership and Referral Act, or PORA)

• The federal anti-kickback statute (AKS)

• State anti-kickback and fee-splitting laws

From advising hospitals on patient data breaches, to creating HIPAA compliance policies for healthcare organizations and self insured companies, Healthwise Legal understands the federal and state laws governing data privacy and security including HIPAA, HITECH Act, CMIA, and CCPA.

Navigating best practices for mitigate risk we advise on the collection, storage, use, disclosure and sharing of patient information and related data and compliance regarding how that information is created, stored, and utilized.

Digital health modalities are expanding now more than ever as the country sees just how necessary telemedicine and digital health products are for the delivery of healthcare services.

It is crucial in this expanding area of healthcare that providers stay current with the various areas of relevant law that impact their ventures, including supervision requirements, scope of practice issues, corporate practice of medicine compliance (including the PC-MSO model) and privacy and data security compliance.

The legal and regulatory challenges in the digital health space can be very different from state to state. At Healthwise Legal we have a deep understanding of this landscape, whether you are in the planning phases of a tele-health venture, creating a digital product, or looking for new options to provide efficient care. We will provide the detailed, representation you need to avoid enforcement activity, understand compliance and strategically grow your business.

At Healthwise Legal we advise on a range of Medicare and Medi-Cal-related issues.

Helping healthcare providers avoid accusations of overpayment and fraud, structuring patient service agreements, advising on reimbursement, developing compliance programs, advising on Medicare Manuals, physician fee schedules and assisting both physicians and entities with participation in the Medicare and Medi-Cal programs.

Whatever the challenge, we will help you navigate the complex Medicare and Medi-Cal landscape.

Whether you are building a home health agency, surgery center or tissue bank, we help you identify the local, state and federal licenses your business needs and seamlessly walk you through each step of the licensing process.

With a longstanding relationship corresponding with the California Department of Public Health, The Department of Healthcare Services, The Board of Behavioral Sciences and the Clinical Laboratory Improvements Amendments division of the Centers for Medicare and Medicaid Services, we get you the answers you need to advance your business forward.