Counseling Healthcare Facilities
Healthcare facilities face an array of legal and regulatory challenges in today’s ever-changing healthcare legal environment.
Our healthcare and FDA lawyers counsel a variety of licensed and non-licensed healthcare facilities and ventures on regulatory and corporate compliance issues. Our clients include:
- Addiction treatment centers
- Ambulatory care facilities
- Clinical laboratories
- Clinical research organizations (CROs)
- Cord blood banks
- Diagnostics and screening facilities (including IDTFs)
- Clinical laboratories (CLIA and state law clinical laboratory issues)
- Home health agencies
- Hospices
- Hospitals
- Information technology companies
- Long-term care facilities
- mHealth, telemedicine, and information technology companies
- Outpatient service providers
- Psychiatric facilities
- Rehabilitation facilities
- Residential treatment facilities
- Senior services facilities
- Skilled nursing facilities
- Sober living facilities
- Urgent care centers
Our transactional practice includes mergers and acquisitions, restructurings, financings, joint ventures, and other arrangements.
California has a confusing landscape of regulatory definitions, including: “adult residential facility,” “clinic,” “community care facility,” “crisis nursery,” foster family agency,” “group home,” “health facility,” “residential care facily for the elderly” (RCFE), “residential care facility for the chronically ill,” “social rehabilitation facility,” and “transitional housing placement program.”
- We advised several healthcare facilities on data breaches involving theft of electronic and/or paper records.
- We counseled a provider of ambulatory EEG services on Medicare IDTF, billing, and fraud and abuse issues.
- We developed an informed consent process for a healthcare facility specializing in the needs of patients with autism.
- We counseled a hospital on whether it could bill the patient’s insurance provider in circumstances under which the admitting physician could not obtain the patient’s signature at the time of admission.
- We drafted and negotiated an agreement for a physician group to provide telemedicine, remote healthcare services, including primary care services, to a hospital’s inpatients.
We also advise on corporate practice of medicine, Physician/provider contracts, Professional Services agreements, medical staff bylaws, risk mitigation, Stark, anti-kickback and fee-splitting, rural/underserved areas and related regulatory issues, which affect healthcare facilities seeking to grow their market share.
Regulatory Issues for Healthcare Facilities
The regulatory issues on which our healthcare facility clients seek legal counsel, can range from HIPAA compliance to California Department of Public Health licensing issues to FDA regulations.
- For example, we assisted one of our clients in responding to an investigation by the California Department of Public Health’s Laboratory Field Services Blood Bank and Biologics Section. This Section enforces various sections of California’s Health & Safety Code which include, for example, provisions for periodic inspection of health facility for which a license or special permit has been issued. Among other penalties, the statute provides for suspension, denial, or revocation of licenses, and for prosecution by district and city attorneys upon evidence of violations within their respective jurisdictions submitted by the Department. We were able to clear misunderstandings, resolve deficiencies in the client’s documentation, and negotiate for lesser enforcement penalties.
- We advised another client on a plan to create a clinic to provide patients with cord blood-based, stem cell injections. Here our counsel required knowledge of relevant FDA regulation of biologics and drugs; FDA regulation of cord blood and stem cell products (principally through the FDA guidance on Human Cells, Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations and related guidance); FDA and FTC rules about substantiation, state law licensing requirements for biologics products and/or stem cell products; and consumer protection laws.
- A healthcare facility asked us to opine on whether its business model met California’s statutory definition of a “congregate health facility” and related regulatory requirements. According to California law, such a facility is “a residential home with a capacity, except as provided in paragraph (4), of no more than 18 beds, that provides inpatient care, including the following basic services: medical supervision, 24-hour skilled nursing and supportive care, pharmacy, dietary, social, recreational, and at least one type of service specified in paragraph (2). The primary need of congregate living health facility residents shall be for availability of skilled nursing care on a recurring, intermittent, extended, or continuous basis. This care is generally less intense than that provided in general acute care hospitals but more intense than that provided in skilled nursing facilities.”
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
