Healthcare Law – Solve & Win

Health care law encompasses health care regulations, licensing and practice issues, privacy and confidentiality/HIPAA, sale acquisition of practice, telemedicine and e-wellness, kickback rules, bioethics, and Medicare/Medicaid regulations. By drawing on the Law Office’s talents and experiences, clients will be aware of nuances of health law and will comply with the requirements of state and federal fraud and abuse laws and other statutory and regulatory challenges unique to health care professional entities. With both in-house and firm experience, the Law Office provides comprehensive array of legal services to health care providers, including:

Legal Review & Advice Relating to the Practice
Malpractice liability risks relating to therapies the practitioner offers.
Risk of prosecution for unlicensed practice of medicine or other professions.
Claims and/or guarantees made in the practice.
Use of any potential “medical devices” under the federal Food, Drug & Cosmetic Act.
Dietary supplement recommendations.
Dietary supplements sales.
FDCA risks relating to off-label or experimental therapies.
Primary/integrative vs. CAM-only care (for MD/DO).
Disciplinary issues (including standard of care).
Scope of practice issues.
Insurance (Medicare) issues (par v. non-par v. opted out).
Insurance (CPT and E&M coding for super-bill; issues of upcoding, unbundling, medical necessity, scope of practice, discounts and waivers, fraud and abuse “incident to” billing
Facilities license (if applicable).
Professional liability insurance (coverage of CAM; medically necessary v. experimental)
General liability insurance (e.g., spa liability; general business liability; employee benefits liability; group health insurance; healthcare billing errors and omissions; directors and officers; employment practices; workers compensation).
Vicarious liability for acts of associated practitioners.
“Medical mall” vs. “center” model.
Analysis of Stark and federal anti-kickback issues for illegal business arrangements (such as splitting fees between MD, Center and practitioner).
Write memo analyzing Stark, anti-kickback and fee-splitting issues and outlining compliant compensation arrangements.
State self-referral and anti-kickback issues and design of flow-of-payments.
Contract between MD/DO and Center/Clinic/Practice/Spa.
Legal and contractual issues involving service as medical director.
Contract between non-medical Practitioner and Center/Clinic/Practice/Spa.
Medical supervision issues (e.g., Botox, spa therapies).
Legal Review & Advice Relating to Marketing Materials (including brochures and main website).
FDA (Food and Drug Administration) issues concerning claims and labeling
FTC (Federal Trade Commission) issues concerning claims, testimonials & endorsement
Draft Legal Forms.
General Informed Consent Form for medicine, chiropractic, acupuncture, massage, etc. (or non-licensed practitioner if state law mandates disclosures).
Nutrition Notice (if applicable—e.g., CA).
FTC/FDA Disclaimer for main website and marketing materials.
Privacy Form (non-HIPAA, mirror form; or HIPAA manual if billing electronically).
Medicare ABN Notice and Patient Assignment or Waiver Forms.
Non-participation letter for insurance companies with whom MD/DO has contract through medical school or hospital affiliation, managed care or MSO contracts.
Letter to malpractice carrier regarding coverage of CAM.
Recommended Additional Services: Advice and Drafting
Advice on Choice of Entity & Incorporation (including professional service or professional medical corporation).
Advice on intellectual property protection (copyright, trademark, trade secrets).
HIPAA Manual and Forms (including Business Associate form).
Agreements covering speaking/consulting, distribution, other services.
Chart review (MD/DO only).
Specialized consent forms (e.g., Lyme disease, IV therapies, IPT, heavy metal challenge diagnostic testing, etc.).
Review of facilities lease.
Develop or review credentialing & quality assurance plan for practitioner selection, and documentation.
CLIA advice (chemical services, lab tests, blood fluids); scope of practice and standard of care issues regarding lab tests.
Physician Employment Agreements
Management Services Organizations (MSO) Agreements

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If you have additional questions or would like to schedule an appointment with Ms. Natbony to discuss your healthcare law related question, please fill out the form below and click “Submit Message.”