The Complete Health Lawyer's Quick Answer Book
Answers to More Than 130 Questions in 13 Areas of Health Law
CHAPTER 1
Corporate Law for Healthcare and Wellness Companies
- What is the corporate practice of medicine doctrine? Are there exceptions?
- Can a corporation or LLC owned by non-physicians employ physicians to provide medical services in Minnesota?
- What types of entities are permitted to practice medicine in Minnesota, and who must own them?
- Can a non-physician own or operate a medical spa or similar healthcare business?
- What services must be performed by a licensed physician versus a chiropractor, nurse practitioner, or other practitioner? Can medical services be delegated to non-licensed staff in a spa or wellness setting?
- Do treatments like IV therapy, hormone therapy, aesthetic injections, or “medical devices” require medical supervision?
- Is alternative healing subject to the corporate practice of medicine doctrine? Are there special laws that apply?
- What liability risks do providers face when offering alternative, experimental, or wellness-based services?
– Zachary J. Crain
CHAPTER 2
Health Insurance – Fully Insured Group Health Plans and the Individual Health Plans
- What are the fully insured group and individual health plan markets?
- What are the major types of health insurance companies and products in the fully insured group and individual markets?
- How are fully insured group and individual health plans regulated?
- Who purchases fully insured group and individual health plans, and how is eligibility determined?
- How are fully insured group and individual health plans paid for?
- What are the key features of fully insured group and individual health plans?
- What consumer protections are required for fully insured group and individual health plans?
- What benefits are required for fully insured group and individual health plans?
- What rights do consumers have when coverage is denied or limited under a fully insured group or individual health plan?
- What transparency requirements apply to fully insured group and individual health plans regarding coverage, pricing, and benefits?
– Caitlyn E. Francois
CHAPTER 3
Medicare
- What are the various “parts” of Medicare and why do those parts matter?
- Medicare seems to have its own language; I hear terms like “provider”, “supplier”, “prospective payment”, “DMEPOS”, “IDTF”, “unbundling”, the “72 hour rule”, “anti-markup rule” and all sorts of other technical terms. What do these mean and why do I need to care about them?
- Talk to me about how different kinds of providers enroll in the Medicare program. Do the same requirements apply to everyone? What kinds of obligations do providers need to think about when enrolling?
- What is the difference among being a “participating,” “non-participating,” and “opt-out” Medicare physician, and why does it matter?
- What kinds of services are covered by Medicare Part B? What services aren’t covered?
- Do I need to comply with Medicare’s “conditions of participation”?
- What does it mean if a physician has a “reassignment”?
- What is the Medicare 36-Month Rule?
- What does it mean to be a provider-based hospital department and what are some of the complexities, if any, associated with provider-based status?
- What does it mean to be “excluded” from Medicare and what are the reasons someone might get excluded?
– Jesse A. Berg
CHAPTER 4
Medicaid
- My practice treats Medicaid patients, but reimbursement rates are very low. Am I required to accept Medicaid, or can I limit the number of Medicaid patients I see?
- What is the difference between Medicaid and Medicare, and why does that difference matter for providers?
- Can I bill a Medicaid patient directly if Medicaid does not fully reimburse me for a service?
- A Medicaid patient gave me private insurance information after the visit. Can I bill the private insurer instead of Medicaid?
- What happens if my practice is accidentally paid twice for the same Medicaid service?
- Can a provider be excluded from Medicaid? If so, what are the most common reasons for exclusion?
- Minnesota uses Medicaid managed care organizations (MCOs). Do different rules apply when billing Medicaid through an MCO?
- Can Medicaid audit my practice? What should I expect if that happens?
- What are my obligations if I discover a billing error or compliance problem involving Medicaid claims?
- Can a provider terminate a Medicaid patient relationship, and if so, what legal steps must be followed?
- Can a provider use a third-party billing company to bill Medicaid? If so, what are the limitations?
- What happens when a provider sells their practice or changes their ownership structure? Do the Medicaid billing rights transfer?
– Jessica M. Anderson & Jennifer A. Forbes
CHAPTER 5
HIPAA & Patient Privacy
- What is “protected health information” (PHI) under HIPAA? Does it include a mere list of patient names?
- What is a “Business Associate” under HIPAA? Am I a Business Associate if I do not collect any PHI in electronic form?
- If I experience a privacy or security incident, when does HIPAA require a written notification to the affected individual(s)?
- Can a patient bring a lawsuit against me for violating HIPAA?
- Complying with the HIPAA Security Rules looks complex and expensive, so how do I start?
- If I provide health care services but only collect fees from patients and never interact with any health insurance, am I regulated by HIPAA or any other federal privacy law?
- How can I de-identify data so that HIPAA no longer regulates my use or disclosure of that data?
- Can I disclose PHI when I receive a subpoena demanding individually identifiable health information?
- Can HIPAA violations be enforced against a Business Associate, or is the provider or health plan always responsible?
- What are the potential civil and criminal penalties for HIPAA violations?
– Ross D’Emanuele
CHAPTER 6
False Claims Act
- What is the False Claims Act, and what types of conduct does it prohibit in healthcare?
- What does it mean to submit a “false” or “fraudulent” claim under the False Claims Act and how does “cause to be presented” affect liability?
- What level of intent or knowledge is required for False Claims Act liability, and what is the difference between the various scienter standards?
- Who can be held liable under the False Claims Act?
- What are some of the more common False Claims Act theories?
- What are some recent trends in False Claims Act cases?
- What are the recent Constitutional challenges to the False Claims Act?
- What is the Circuit split over the causation standard in a False Claims Act case premised on Anti-Kickback Statute violations?
- What are some of the most successful False Claims Act defenses?
- What penalties and damages may be imposed for False Claims Act violations, and how does the Excessive Fines clause impact the analysis?
– Chad A. Blumenfield, Nicholas Scheiner & Kristen Rau-Yamashiro
CHAPTER 7
The Stark Law (Physician Self-Referral Law)
- What is the Stark Law and who does it apply to?
- What are “Designated Health Services,” and why are they central to Stark Law compliance?
- What types of “financial relationships” trigger the Stark Law?
- How does the Stark Law differ from the Anti-Kickback Statute?
- What exceptions permit otherwise prohibited referrals under the Stark Law?
- What are common Stark Law risk areas for Minnesota health care providers?
- Can unintentional or technical mistakes still result in a Stark Law violation?
- What are the potential consequences of Stark Law noncompliance?
- What happens if a Stark Law violation is discovered after claims have already been submitted or paid?
- What steps can providers take to reduce the risk of a Stark Law violation?
– David M. Glaser & Ethan C. Wold
CHAPTER 8
Anti-Kickback Statute
- What is the federal Anti-Kickback Statute, and what conduct does it prohibit?
- What is an Anti-Kickback Statute safe harbor, and what are the most common safe harbors used in health care arrangements?
- What are the key provisions to include in physician services agreements to mitigate risk under the AntiKickback Statute?
- Why is documenting fair market value and commercial reasonableness in arrangements with referral sources important, and what valuation methods best support fair market value and commercial reasonableness to withstand Anti-Kickback Statute scrutiny?
- How does the government enforce Anti-Kickback Statute violations, and who can be held liable?
- What elements must the government prove to establish a criminal violation of the Anti-Kickback Statute?
- When can an Anti-Kickback Statute violation give rise to a False Claims Act violation?
- My company/client received a civil investigative demand from the Office of Inspector General. What are the immediate steps to take in response to the civil investigative demand?
- What best practices and tools should my organization implement to comply with the AKS?
– Aaron T. Dobosenski & Larissa Morgan
CHAPTER 9
Physician Employment Issues
- What should I watch out for when completing job applications and credentialing forms?
- What key terms in a physician employment contract deserve the most attention?
- Who is responsible if a malpractice claim arises—and what should I understand about malpractice coverage, tail insurance, and indemnification?
- What should I know about forgivable loans, signing bonuses, and repayment provisions?
- If concerns are raised about my patient care, can I resign before the matter becomes reportable to the Minnesota Board of Medical Practice or the NPDB?
- If I raise patient-safety concerns at work, does Minnesota law protect me from retaliation?
- Can my employer change my compensation, schedule, or duties after I’ve signed my contract?
- Can I take medical or family leave—and what employment or licensure risks should I be aware of?
- What should I do if the employment relationship isn’t working?
- If I leave my practice, can my employer restrict where I practice or which patients I contact?
– Timothy S. Christensen & Peter G. Christian
CHAPTER 10
Medical Certification in Employee Benefits
- What employee benefit programs most commonly require physician involvement or certification?
- What is a physician's legal role in certifying medical leave under the federal Family and Medical Leave Act (FMLA)?
- How does Minnesota’s Paid Family and Medical Leave program affect physician certification and documentation obligations?
- Can a physician refuse to complete FMLA, paid leave, or disability paperwork for a patient?
- What legal risks arise from inaccurate, incomplete, or inconsistent medical certifications?
- How do group medical plans determine medical necessity?
- What role does physician certification play in group medical plan determinations of medical necessity?
- What role do physicians play in short-term and long-term disability benefit determinations?
- What privacy and consent issues arise when physicians communicate with employers, insurers, or government agencies about patient benefits?
- What common disputes or legal issues arise when patients, employers, or benefit programs challenge a physician’s certification or opinion?
– Thomas B. Henke
CHAPTER 11
Medical Malpractice
- What is medical malpractice under Minnesota law?
- What duty of care is owed to patients under Minnesota law?
- How is the standard of care determined in a malpractice lawsuit?
- What does it take to show causation in a medical malpractice claim?
- What types of damages may be recovered in a medical malpractice case under Minnesota law?
- What is the role of expert witnesses in Minnesota medical malpractice cases?
- What constitutes an informed consent claim under Minnesota law?
- How is vicarious liability established in a Minnesota medical malpractice case?
- What defenses are commonly raised by healthcare providers in medical malpractice cases?
- What timing considerations exist in Minnesota medical malpractice cases?
– Rachel L. Barrett
CHAPTER 12
Telemedicine
- What is telemedicine, and how does Minnesota law distinguish telemedicine from in-person care?
- Do providers need to be licensed in Minnesota to provide telemedicine services to Minnesota patients?
- How is a provider–patient relationship established in telemedicine, and why does it matter legally?
- Are there special informed consent requirements for telemedicine visits?
- Can providers prescribe medications through telemedicine and what legal limits apply?
- How do privacy and data security laws apply to telemedicine services?
- How is telemedicine reimbursed, and do the same payment rules apply as in-person care?
- What standards of care apply to telemedicine, and can telemedicine increase malpractice risk?
- Can telemedicine be used to provide ongoing or chronic care, or is it limited to one-time visits?
- What are the most common legal risks and compliance pitfalls associated with telemedicine?
– Jason K. Engelhart
CHAPTER 13
FDA Regulation in Healthcare
- What is the role of the U.S. Food and Drug Administration (FDA) in regulating healthcare and why does it matter to providers?
- How does the FDA regulate drugs, biologics, and medical devices differently?
- What is “off-label” use, and is it legal for physicians to prescribe drugs or use devices off-label?
- How do FDA approval and clearance processes affect what products providers may use in patient care?
- What restrictions apply to the marketing and promotion of FDA-regulated products, and how can those rules affect providers?
- What obligations do providers have when using investigational or experimental products?
- How do FDA regulations intersect medical malpractice and standards of care?
- What role do FDA warnings, recalls, and safety communications play in provider responsibilities?
- How do FDA regulations affect emerging technologies such as digital health tools, software, and artificial intelligence used in patient care?
- What obligations do healthcare providers have when patients request or inquire about FDA-unapproved treatments or products?
– Theodore M. Thompson
